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    Veranova Methylphenidate Hydrochloride

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    xyz-pharma-m-2025-01-20

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    ACTIVE PHARMA INGREDIENTS

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    Synopsis

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    Chemistry

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    Also known as: 298-59-9, Centedrin, Centedrine, Methylphenidate hcl, Concerta, Ritalin
    Molecular Formula
    C14H20ClNO2
    Molecular Weight
    269.77  g/mol
    InChI Key
    JUMYIBMBTDDLNG-UHFFFAOYSA-N
    Methylphenidate Hydrochloride
    A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
    1 2D Structure

    Methylphenidate Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl 2-phenyl-2-piperidin-2-ylacetate;hydrochloride
    2.1.2 InChI
    InChI=1S/C14H19NO2.ClH/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12;/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3;1H
    2.1.3 InChI Key
    JUMYIBMBTDDLNG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC(=O)C(C1CCCCN1)C2=CC=CC=C2.Cl
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Centedrin

    2. Concerta

    3. Daytrana

    4. Equasym

    5. Hydrochloride, Methylphenidate

    6. Metadate

    7. Methylin

    8. Methylphenidate

    9. Phenidylate

    10. Ritalin

    11. Ritalin Sr

    12. Ritalin-sr

    13. Ritaline

    14. Tsentedrin

    2.2.2 Depositor-Supplied Synonyms

    1. 298-59-9

    2. Centedrin

    3. Centedrine

    4. Methylphenidate Hcl

    5. Concerta

    6. Ritalin

    7. Methylphenidate.hcl

    8. Metadate

    9. Methylin

    10. Metilfenidat Hydrochloride

    11. Ritalin Sr

    12. H-tic-otbu.hcl

    13. Threo-methylphenidate Hydrochloride

    14. Daytrana

    15. Methylin Er

    16. Methylphenidylacetate Hydrochloride

    17. Ritalin La

    18. Methylphenidate (hydrochloride)

    19. Ritalin Hydrochloride

    20. Ritalin-sr

    21. Methyl 2-phenyl-2-piperidin-2-ylacetate;hydrochloride

    22. Nsc-169868

    23. Ncgc00091942-01

    24. Rilaline

    25. Dsstox_cid_886

    26. Dsstox_rid_75843

    27. Dsstox_gsid_20886

    28. Methyl Phenyl(piperidin-2-yl)acetate Hydrochloride

    29. Quillichew

    30. Quillivant

    31. Aptensio

    32. Foquest

    33. Meridil Hydrochloride

    34. Oros Mph

    35. Aptensio Xr

    36. Rilatine

    37. Quillivant Xr

    38. Quillichew Er

    39. Chebi:31836

    40. Cas-298-59-9

    41. Nsc 169868

    42. Ccris 6258

    43. Methyl 2-phenyl-2-(piperidin-2-yl)acetate Hydrochloride

    44. Einecs 206-065-3

    45. Spd544

    46. Spd-544

    47. Methylphenidate Hydrochloride Er

    48. Concerta (tn)

    49. Metadate (tn)

    50. Methyl Phenidate Hcl

    51. Ritalin (tn)

    52. Methyl Alpha-phenyl-2-piperidineacetate Hydrochloride

    53. Quillivant Xr (tn)

    54. Methylphenidate Hydrochloride [usp:jan]

    55. Methylphenidate(ritalin)

    56. Methyl .alpha.-phenyl-2-piperidineacetate Hydrochloride

    57. Chembl1722

    58. Schembl41067

    59. Mls003922100

    60. Dtxsid8020886

    61. Methylphenidate Hydrochloride Cii

    62. Hy-b1091a

    63. Pharmakon1600-01505907

    64. Bcp34044

    65. Tox21_111186

    66. Tox21_200309

    67. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride

    68. Mfcd00058191

    69. Nsc169868

    70. Nsc759278

    71. Akos016010356

    72. Ccg-213572

    73. Cs-4658

    74. Nsc-759278

    75. Sb13180

    76. Wln: T6mtj Byr & Vo1 & Gh

    77. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester, Hydrochloride, (r*,r*)-(+-)-

    78. Methylphenidate Hydrochloride (jan/usp)

    79. Ncgc00257863-01

    80. Smr000058998

    81. Ft-0672045

    82. Ft-0672046

    83. Ft-0672048

    84. Ft-0672050

    85. D01296

    86. 298m599

    87. 2-piperidineacetic Acid, Methyl Ester, Hydrochloride

    88. Methylphenidate Hydrochloride(ritalin Hydrochloride)

    89. Methylphenidate Hcl;threo-methylphenidate Hydrochloride

    90. Q26840773

    91. Methyl 2-phenyl-2-(piperidin-2-yl)acetate Hcl

    92. Methylphenidate Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    93. Methylphenidate Hydrochloride Solution, (racemic Mixture), Ampule Of 1 Ml, 1.0 Mg/ml In Methanol (as Free Base), Certified Reference Material

    2.3 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 269.77 g/mol
    Molecular Formula C14H20ClNO2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass269.1182566 g/mol
    Monoisotopic Mass269.1182566 g/mol
    Topological Polar Surface Area38.3 Ų
    Heavy Atom Count18
    Formal Charge0
    Complexity249
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 16  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 16  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    3 of 16  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    4 of 16  
    Drug NameMethylin er
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    5 of 16  
    Drug NameMethylphenidate hydrochloride
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release; Tablet; Capsule, extended release; Solution
    Routeoral; Oral
    Strength10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyCorepharma; Vintage Pharms; Actavis Labs Fl; Sun Pharm Inds; Barr Labs; Mallinckrodt; Watson Labs; Actavis S Atlantic; Teva Pharms; Caraco; Ucb; Kudco Ireland; Tris Pharma

    6 of 16  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    7 of 16  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    8 of 16  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    9 of 16  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    10 of 16  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    11 of 16  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    12 of 16  
    Drug NameMethylin er
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    13 of 16  
    Drug NameMethylphenidate hydrochloride
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release; Tablet; Capsule, extended release; Solution
    Routeoral; Oral
    Strength10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyCorepharma; Vintage Pharms; Actavis Labs Fl; Sun Pharm Inds; Barr Labs; Mallinckrodt; Watson Labs; Actavis S Atlantic; Teva Pharms; Caraco; Ucb; Kudco Ireland; Tris Pharma

    14 of 16  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    15 of 16  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    16 of 16  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Drug Indication

    Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Central Nervous System Stimulants

    A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)

    Dopamine Uptake Inhibitors

    Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]

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    GDUFA

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    GDUFA

    DMF Review : Complete

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    Methylphenidate Hydrochloride EP/USP

    Date of Issue : 2022-08-25

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm : Plot No. 3102/B, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat I...

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    methyl phenidate hcl EP/USP

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0045nA2

    Address of the Firm : Plot No. E-7, 8, 9 MIDC, Industrial Area, Chikalthana, Aurangabad-431006

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    Biperiden Hydrochloride (Ph. Eur./USP)

    Date of Issue : 2019-08-13

    Valid Till : 2022-08-12

    Written Confirmation Number : WC-0228

    Address of the Firm : Sy No.505 Padmati Somaram Road Bibinagar Village and Mandal Nalgonda Dist AP

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    05

    Sriam Labs

    India
    Duphat
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    Sriam Labs

    India
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    Duphat
    Not Confirmed
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    Biperiden hydrochloride Ph.Eur.USP

    Date of Issue : 2018-10-01

    Valid Till : 2021-10-01

    Written Confirmation Number : WC-288

    Address of the Firm : Sy.No.505 Padmati Somaram Road, Bldinagar Village and Mandal Nalgonda District T...

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    06

    Sun Pharmaceutical Industries Limited

    India
    Duphat
    Not Confirmed
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    Sun Pharmaceutical Industries Limited

    India
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    Methylphenidate Hydrochloride USP/EP

    Date of Issue : 2022-08-08

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0168

    Address of the Firm : Plot No. 24/2, & 25, Phase -IV, GIDC, Industrial Zone, At & Post - Panoli, Dist....

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    Listed Suppliers

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    01

    Veranova

    U.S.A
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    Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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    Methylphenidate Hydrochloride

    About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

    Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
    Veranova

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    02

    SCI Pharmtech

    Taiwan
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    Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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    Methylphenidate Hydrochloride

    About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...

    SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and production facilities are fully equipped, and our experienced team ensures high-quality results. We work with pharmaceutical and specialty companies around the world to create important intermediates, APIs, and tailored products. Our facility meets FDA, EDQM, and Taiwan TFDA standards for versatile, large-scale manufacturing, ensuring reliable and compliant production processes.
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    03

    Cohance Lifesciences

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Methylphenidate Hydrochloride

    About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

    Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.
    Cohance

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    04

    Malladi Drugs & Pharmaceuticals Lim...

    India
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    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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    Methylphenidate Hydrochloride

    About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...

    Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine and pseudoephedrine salts. Today, it is the leading manufacturer of APIs in the cough and cold segment. It also has a dominant presence in several therapeutic segments like antihistamines, anti-convulsants, anti-depressants and anxiolytics (CNS). Malladi exports its products to around 60 countries and over 85% of its revenue is generated from exports. Its manufacturing facilities have been approved by the FDA, EDQM, KFDA, TGA and various other regulatory agencies.
    Malladi

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    05

    HRV Global Life Sciences

    India
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    Not Confirmed
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Methylphenidate Hydrochloride

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    06

    Noramco

    U.S.A
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    Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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    Methylphenidate Hydrochloride

    About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...

    Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and manufacturing, Noramco offers services like supply-chain integration for high-purity controlled substances, efficient routes to APIs, analytical data, stability studies, regulatory help, formulation-friendly particle size grades, extended technical packages, DEA-compliant security and production capacity from kilos to multi-ton supply. Noramco also offers world-class supply security for controlled substances, from Schedule I to Schedule III.
    Noramco

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    07

    Tenatra Chemie

    India
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    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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    Methylphenidate Hydrochloride

    About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

    Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Chemie Private Limited (TCPL) was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
    Tenatra

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    08

    Dishman Carbogen Amcis

    India
    BIO Partnering at JPM
    Not Confirmed
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    Dishman Carbogen Amcis

    India
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    Methylphenidate Hydrochloride

    About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

    We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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    09

    Harman Finochem

    India
    BIO Partnering at JPM
    Not Confirmed
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    Harman Finochem

    India
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Methylphenidate Hydrochloride

    About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...

    Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of which 10 are Essential Drugs as per the WHO Model List. We deliver top quality products to more than 35 countries across the globe. Harman Finochem ensures that its customers worldwide are delighted by receiving APl’s which are safe, efficient and of highest quality. We adhere to principles of cGmp and our team at all levels is committed to achieving this corporate excellence goal.
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    10

    Mallinckrodt Pharmaceuticals

    Ireland
    BIO Partnering at JPM
    Not Confirmed
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    Mallinckrodt Pharmaceuticals

    Ireland
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    Not Confirmed
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    Methylphenidate Hydrochloride

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

    Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696617000,"product":"SAP CODE:2021237 HARMLESS PHARMACEUTICALBULK DRUG METHYLPHENIDATE HYDROCHLORIDEPH. EUR. B.NO.PEMTNNF017, 016, 011.","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"DEVELCO PHARMA GMBH, GRIENMATT 27","customerCountry":"GERMANY","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"605","totalValueFC":"190906.3","currency":"USD","unitRateINR":49653.125,"date":"07-Oct-2023","totalValueINR":"15889000","totalValueInUsd":"190906.3","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"4467292","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715625000,"product":"HSN CODE : 29333323 SAP CODE : 2021237 HARMLESS PHARMACEUTICAL BULK DRUG METHYLPHENIDATE HYDROCHLORIDE PH. EUR.PACK : KG","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"M\/S.","customerCountry":"SWITZERLAND","quantity":"320.00","actualQuantity":"320","unit":"KGS","unitRateFc":"510","totalValueFC":"159766.6","currency":"USD","unitRateINR":41616.278124999997,"date":"14-May-2024","totalValueINR":"13317209","totalValueInUsd":"159766.6","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"9848852","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"METHYLPHENIDATE HYDROCHLORIDE (TAXINV#91201010 DT:10.07.2024 GSTN#27AABCH3223J1ZS-HARMAN FINOCHEM LIMITED)**","address":"150 Adarsh Industrial Estate","city":"Mumbai","supplier":"VRUDHI LIFESCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"TEHRAN","customer":"VANA DAROU GOSTAR","customerCountry":"IRAN","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"62402.7","totalValueFC":"221624.3","currency":"INR","unitRateINR":61752.720000000001,"date":"12-Jul-2024","totalValueINR":"18525816","totalValueInUsd":"221624.3","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"2365747","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"IRAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"150 Adarsh Industrial Estate, Mumbai","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"PHARMACEUTICAL-ACTIVE PHARMACEUTICAL INGREDIENT.........METHYLPHENIDATE HYDROCHLORIDE EP B.NO.MPH2200324 CAS NO:298-59-9","address":"401 FIFTH FLOOR, NAINDHARA APARTME","city":"AHMEDABAD, GUJARAT","supplier":"MOLKEM CHEMICALS PRIVATE ","supplierCountry":"INDIA","foreign_port":"GUARULHOS","customer":"TO THE ORDER","customerCountry":"BRAZIL","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"750","totalValueFC":"367.5","currency":"USD","unitRateINR":61588.139999999999,"date":"03-Sep-2024","totalValueINR":"30794.07","totalValueInUsd":"367.5","indian_port":"Ahmedabad Air","hs_no":"29333323","bill_no":"3732393","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"401 FIFTH FLOOR, NAINDHARA APARTME, AHMEDABAD, GUJARAT","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712082600,"product":"METHYLPHENIDATE HYDROCHLORIDE-METHYLPHENIDATE HCI(US23600557)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CURIA","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"VIATRIS","customerCountry":"INDIA","quantity":"200.53","actualQuantity":"200.53","unit":"KGS","unitRateFc":"1100","totalValueFC":"221915.5","currency":"USD","unitRateINR":"92412.9","date":"03-Apr-2024","totalValueINR":"18531566.06","totalValueInUsd":"221915.5","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"2863206","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"2460 W BENNETT STREET SPRINGFIELD MO 65807- USSDNF United States","customerAddress":"564\/A\/22, ROAD NO.92"}]
    07-Oct-2023
    03-Sep-2024
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    Drugs in Development

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    • Development Update
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Dr. Reddy's Laboratories Announces the Launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, in the U.S. Market

    Details:

    Dr. Reddy’s Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in strengths of 18 mg, 27 mg, 36 mg, and 54 mg tablets in bottle count sizes of 100.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Methylphenidate Hydrochloride-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 03, 2020

    Dr Reddy Company Banner

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    Dr. Reddy's Laboratories

    India
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    Booth #9.1B48
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories Announces the Launch of Methylphenidate Hydrochloride Extended-Release Ta...

    Details : Dr. Reddy’s Methylphenidate Hydrochloride Extended-Release Tablets, USP are available in strengths of 18 mg, 27 mg, 36 mg, and 54 mg tablets in bottle count sizes of 100.

    Brand Name : Methylphenidate Hydrochloride-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 03, 2020

    Dr Reddy Company Banner

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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Tris Pharma Expands Global ADHD Drug Availability with New Approvals

    Details:

    Quillivant (methylphenidate HCl) is a dopamine/norepinephrine reuptake inhibitor, which is indicated for the treatment of attention deficit hyperactivity disorder in patients aged 6 to 65 years.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Quillivant

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 19, 2024

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    02

    Tris Pharma Inc

    U.S.A
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Tris Pharma Expands Global ADHD Drug Availability with New Approvals

    Details : Quillivant (methylphenidate HCl) is a dopamine/norepinephrine reuptake inhibitor, which is indicated for the treatment of attention deficit hyperactivity disorder in patients aged 6 to 65 years.

    Brand Name : Quillivant

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 19, 2024

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    Collegium Completes Acquisition of Ironshore Therapeutics

    Details:

    Collegium will acquire Ironshore, which will help to expand into neurology, which includes JORNAY PM (methylphenidate HCl). It is indicated for the treatment of ADHD in patients 6 years and older.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Jornay PM

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Collegium Pharmaceutical

    Deal Size: $525.0 million Upfront Cash: $525.0 million

    Deal Type: Acquisition September 04, 2024

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    03

    Ironshore Pharmaceuticals

    U.S.A
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    Not Confirmed

    Ironshore Pharmaceuticals

    U.S.A
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    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Collegium Pharmaceutical

    Deal Size : $525.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Collegium Completes Acquisition of Ironshore Therapeutics

    Details : Collegium will acquire Ironshore, which will help to expand into neurology, which includes JORNAY PM (methylphenidate HCl). It is indicated for the treatment of ADHD in patients 6 years and older.

    Brand Name : Jornay PM

    Molecule Type : Small molecule

    Upfront Cash : $525.0 million

    September 04, 2024

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    Collegium to Acquire Ironshore Therapeutics, Expanding into Neurology

    Details:

    Collegium will acquire Ironshore, which will help to expand into neurology, which includes JORNAY PM (methylphenidate HCl). It is indicated for the treatment of ADHD in patients 6 years and older.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Jornay PM

    Study Phase: DiscoveryProduct Type: Small molecule

    Sponsor: Collegium Pharmaceutical

    Deal Size: $550.0 million Upfront Cash: $525.0 million

    Deal Type: Acquisition July 29, 2024

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    04

    Ironshore Pharmaceuticals

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed

    Ironshore Pharmaceuticals

    U.S.A
    arrow
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    Not Confirmed
    • fda
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    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Discovery

    Partner/Sponsor/Collaborator : Collegium Pharmaceutical

    Deal Size : $550.0 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Collegium to Acquire Ironshore Therapeutics, Expanding into Neurology

    Details : Collegium will acquire Ironshore, which will help to expand into neurology, which includes JORNAY PM (methylphenidate HCl). It is indicated for the treatment of ADHD in patients 6 years and older.

    Brand Name : Jornay PM

    Molecule Type : Small molecule

    Upfront Cash : $525.0 million

    July 29, 2024

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    Alora Pharmaceuticals, LLC Announces the Availability of Once-Daily Relexxii® for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

    Details:

    Relexxii (methylphenidate HCl) is a dopamine/norepinephrine reuptake inhibitor, small molecule drug candidate, which is currently being evaluated for the treatment of attention deficit hyperactivity disorder in patients aged 6 to 65 years.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Relexxii

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 19, 2023

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    05

    Alora Pharmaceuticals

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed

    Alora Pharmaceuticals

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Alora Pharmaceuticals, LLC Announces the Availability of Once-Daily Relexxii® for the Treatment o...

    Details : Relexxii (methylphenidate HCl) is a dopamine/norepinephrine reuptake inhibitor, small molecule drug candidate, which is currently being evaluated for the treatment of attention deficit hyperactivity disorder in patients aged 6 to 65 years.

    Brand Name : Relexxii

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 19, 2023

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    Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Defici...

    Details:

    Quillivant ER (methylphenidate) Oral Suspension and Chewable Tablet R is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Quillivant ER

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 25, 2023

    blank

    06

    Tris Pharma Inc

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed

    Tris Pharma Inc

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP
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    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER...

    Details : Quillivant ER (methylphenidate) Oral Suspension and Chewable Tablet R is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder.

    Brand Name : Quillivant ER

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 25, 2023

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    Tris Pharma Announces US District Court Upholds Validity of QuilliChew ER® Patents; Rules Teva Infringes Tris Patents

    Details:

    QuilliChew ER (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: QuilliChew

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Teva Pharmaceutical Industries

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 18, 2022

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    07

    Tris Pharma Inc

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed

    Tris Pharma Inc

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Tris Pharma Announces US District Court Upholds Validity of QuilliChew ER® Patents; Rules Teva In...

    Details : QuilliChew ER (methylphenidate hydrochloride) is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older.

    Brand Name : QuilliChew

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 18, 2022

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    Brand Institute Partners on Brand Name Development for FDA Approved Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

    Details:

    RELEXXII® (methylphenidate hydrochloride extended-release tablets) is an oral medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults up to the age of 65 and pediatric patients 6 years of age and older.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Relexxii

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Osmotica Pharmaceuticals

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 11, 2022

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    08

    Brand Institute

    Country
    arrow
    PharmaVenue
    Not Confirmed

    Brand Institute

    Country
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    PharmaVenue
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Osmotica Pharmaceuticals

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Brand Institute Partners on Brand Name Development for FDA Approved Treatment for Attention Defici...

    Details : RELEXXII® (methylphenidate hydrochloride extended-release tablets) is an oral medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults up to the age of 65 and pediatric patients 6 years of age and older.

    Brand Name : Relexxii

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 11, 2022

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    Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA in Europe

    Details:

    Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the SODAS (Spheroidal Oral Drug Absorption System) technology.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Ritalin LA

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Societal CDMO

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 05, 2022

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    09

    InfectoPharm Drugs and Consilium

    Germany
    arrow
    PharmaVenue
    Not Confirmed

    InfectoPharm Drugs and Consilium

    Germany
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Societal CDMO

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA...

    Details : Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the SODAS (Spheroidal Oral Drug Absorption System...

    Brand Name : Ritalin LA

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    May 05, 2022

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    Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA® in Europe

    Details:

    Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the proprietary SODAS® technology.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Ritalin LA

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: InfectoPharm Drugs and Consilium

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement May 05, 2022

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    10

    Societal CDMO

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed

    Societal CDMO

    U.S.A
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Methylphenidate Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : InfectoPharm Drugs and Consilium

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA...

    Details : Ritalin LA is indicated for the treatment of attention deficit hyperactivity disorder. The product is an extended-release formulation of methylphenidate hydrochloride with a bi-modal release profile using the proprietary SODAS® technology.

    Brand Name : Ritalin LA

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    May 05, 2022

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    01

    Cohance Lifesciences

    India
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    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate Hydrochloride

    Brand Name :

    Dosage Form : Extended Release Capsule

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Cohance Lifesciences

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate Hydrochloride

    Brand Name :

    Dosage Form : Extended Release Capsule

    Dosage Strength : 20MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    03

    Cohance Lifesciences

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate Hydrochloride

    Brand Name :

    Dosage Form : Extended Release Capsule

    Dosage Strength : 30MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

    Product Web Link

    Virtual Booth

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    04

    Cohance Lifesciences

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate Hydrochloride

    Brand Name :

    Dosage Form : Extended Release Capsule

    Dosage Strength : 40MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    05

    Cohance Lifesciences

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate Hydrochloride

    Brand Name :

    Dosage Form : Modified Release Pellet

    Dosage Strength : 11%

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

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    Digital Content

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    06

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : METHYLPHENIDATE HYDROCHLORIDE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 30MG

    Packaging :

    Approval Date : 2011-12-01

    Application Number : 78458

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    07

    Dr. Reddy's Laboratories

    India
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    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : METHYLPHENIDATE HYDROCHLORIDE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 40MG

    Packaging :

    Approval Date : 2011-12-01

    Application Number : 78458

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    08

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
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    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : METHYLPHENIDATE HYDROCHLORIDE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 60MG

    Packaging :

    Approval Date : 2016-06-23

    Application Number : 78458

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    09

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
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    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : METHYLPHENIDATE HYDROCHLORIDE

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2018-02-26

    Application Number : 200886

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    10

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI WW Frankfurt
    Booth #9.1B48
    • fda
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    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Flag India
    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : METHYLPHENIDATE HYDROCHLORIDE

    Dosage Form : TABLET, EXTENDED RELEASE;ORAL

    Dosage Strength : 27MG

    Packaging :

    Approval Date : 2020-07-29

    Application Number : 213473

    Regulatory Info : RX

    Registration Country : USA

    Dr Reddy Company Banner

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    01

    Cohance Lifesciences

    India
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    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate Hydrochloride

    Brand Name :

    Dosage Form : Extended Release Capsu...

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    01

    Cohance Lifesciences

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
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    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Methylphenidate Hydrochloride

    Dosage : Extended Release Capsu...

    Dosage Strength : 10MG

    Brand Name :

    Approval Date :

    Application Number :

    Registration Country : India

    Cohance

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    02

    Cohance Lifesciences

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate Hydrochloride

    Brand Name :

    Dosage Form : Extended Release Capsu...

    Dosage Strength : 20MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

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    Virtual Booth

    Digital Content

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    02

    Cohance Lifesciences

    India
    arrow
    PharmaVenue
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Methylphenidate Hydrochloride

    Dosage : Extended Release Capsu...

    Dosage Strength : 20MG

    Brand Name :

    Approval Date :

    Application Number :

    Registration Country : India

    Cohance

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 10187

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    DOSAGE - TABLET;ORAL - 20MG

    USFDA APPLICATION NUMBER - 10187

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 10187

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 18029

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    DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORA...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML

    USFDA APPLICATION NUMBER - 202100

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 205831

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

    USFDA APPLICATION NUMBER - 205831

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG

    USFDA APPLICATION NUMBER - 205831

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG

    USFDA APPLICATION NUMBER - 205831

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG

    USFDA APPLICATION NUMBER - 205831

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG

    USFDA APPLICATION NUMBER - 205831

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG

    USFDA APPLICATION NUMBER - 205831

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    DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;O...DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG

    USFDA APPLICATION NUMBER - 207960

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    DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;O...DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG

    USFDA APPLICATION NUMBER - 207960

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    DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;O...DOSAGE - TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG

    USFDA APPLICATION NUMBER - 207960

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 18MG

    USFDA APPLICATION NUMBER - 21121

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 27MG

    USFDA APPLICATION NUMBER - 21121

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 36MG

    USFDA APPLICATION NUMBER - 21121

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 54MG

    USFDA APPLICATION NUMBER - 21121

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 21259

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG

    USFDA APPLICATION NUMBER - 21259

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG

    USFDA APPLICATION NUMBER - 21259

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 40MG

    USFDA APPLICATION NUMBER - 21259

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG

    USFDA APPLICATION NUMBER - 21259

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG

    USFDA APPLICATION NUMBER - 21259

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    DOSAGE - SOLUTION;ORAL - 10MG/5ML

    USFDA APPLICATION NUMBER - 21419

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    DOSAGE - SOLUTION;ORAL - 5MG/5ML

    USFDA APPLICATION NUMBER - 21419

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    DOSAGE - TABLET, CHEWABLE;ORAL - 10MG **Feder...DOSAGE - TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21475

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    DOSAGE - TABLET, CHEWABLE;ORAL - 2.5MG **Fede...DOSAGE - TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21475

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    DOSAGE - TABLET, CHEWABLE;ORAL - 5MG **Federa...DOSAGE - TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21475

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    US drug shortages hit record high in Q1 2024, impacts cancer, ADHD drugs; Lilly, Novo ramp up production

    US drug shortages hit record high in Q1 2024, impacts cancer, ADHD drugs; Lilly, Novo ramp up production

    Drug shortages are threatening healthcare systems the world over. Be it the US, Canada, Europe or Africa, drug scarcities are straining healthcare systems and costing lives.In the US, the first quarter (Q1) of 2024 saw a staggering 323 drug shortages, the highest number recorded since the American Society of Health-System Pharmacists (ASHP) began tracking such data in 2001. However, Q2 2024 saw active drug shortages reduce to 300 drugs.While the shortages span a wide range of medications, five categories have been severely impacted in the US — central nervous system drugs, antimicrobials, hormone agents, injectable fluids and electrolytes, and chemotherapy drugs. Other critical medications in short supply include drugs to treat attention deficit hyperactivity disorder (ADHD).View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available)Chemo scarcities spark concerns; vaccine shortage hampers mpox response in AfricaIn the US, shortage of at least 21 chemotherapy drugs has impacted cancer treatments. A survey undertaken by the National Comprehensive Cancer Network found 89 percent of participating centers reporting shortages of at least one critical systemic anticancer therapy. These included drugs like vinblastine, etoposide and topotecan. Since early 2023, supply issues have led to what’s now known as the “carboplatin shortage”, a key platinum-based chemo drug that is impacting cancer treatment. Carboplatin is crucial for treating various cancers, including ovarian, lung, and breast cancer.The good news is that there has been a reduction in shortages of platinum-based chemo drugs such as carboplatin and cisplatin. In fact, the FDA website now mentions the shortage of cisplatin as resolved. However, the shortage of carboplatin persists.Meanwhile, Africa is facing an acute shortage of diagnostic kits, treatments and vaccines to fight the outbreak of monkeypox (mpox). The Africa Centers for Disease Control and Prevention estimates it would need 10 million vaccines to stop the outbreak. Bavarian Nordic’s Jynneos is currently the only widely approved mpox vaccine, and countries like the US, Spain, France and Germany have pledged doses of Jynneos to help Africa fight the outbreak.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Drug shortages impacts ADHD patients in US; Canada implements tiered systemThe US Food and Drug Administration (FDA) first reported a shortage of Adderall, a common ADHD treatment, in October 2022. Since then, the shortage has spread to other crucial medications like Ritalin, Vyvanse, and Focalin. This is a significant issue for the roughly 10 million adults and six million children in the US who rely on such drugs to manage their ADHD symptoms.An already concerning shortage of ADHD medications in the US has the potential to worsen due to some recent events. The Centers for Disease Control and Prevention (CDC) issued a health advisory in June, warning that the arrest of two telehealth executives from Done Global, a digital health company, could exacerbate the ADHD medication shortage. Done Global was accused of illegally distributing Adderall online. The arrests could disrupt care not only for Done Global patients but also for those who use other telehealth services.Meanwhile, Canada has implemented a tiered system for addressing drug shortages, with tier 3 shortages being those with the greatest potential impact on the country’s drug supply and healthcare system. Currently, there are 20 drugs listed under tier 3.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) GLP-1 drug shortages create US$ 1 bn shadow industry; Lilly, Novo expand capacitiesThe shortage of glucagon-like peptide-1 (GLP-1) receptor agonists, such as Ozempic, Saxenda, Trulicity, Victoza, Mounjaro, and Zepbound, has been grabbing headlines. These drugs are used in the treatment of diabetes and in weight management.The shortage of these drugs has led to a surge in demand for compounded versions of these medications, creating both opportunities and significant risks. While the FDA’s Food, Drug, and Cosmetic Act allows it to turn a blind eye to pharmacists producing and selling non-approved compounded versions under certain circumstances, this practice has led to a billion-dollar shadow industry of compounded GLP-1 drugs.Eli Lilly has discovered compounded drugs advertised as tirzepatide (Mounjaro and Zepbound) with significant safety, sterility, and efficacy issues. In response to the safety risks, Lilly has taken legal action against several wellness centers, medical spas, and other sellers in the US.To address the supply issues, Lilly has announced its largest manufacturing investment yet, investing an additional US$ 5.3 billion at its Indiana site. Similarly, Novo Nordisk’s parent company is acquiring Catalent for US$ 16.5 billion to increase Wegovy production. Novo is also investing US$ 4.1 billion to develop a new manufacturing facility in Clayton, North Carolina (US).The FDA website continues to list Novo and Lilly’s GLP-1 drugs as “Currently in Shortage”, even though the drugmakers say otherwise. The EMA website says the shortage of Novo’s Wegovy has been resolved but Lilly’s Trulicity and Novo’s Saxenda continue to be in shortage.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) FDA works closely with cancer drugmakers; France introduces roadmap to address drug shortagesApart from pharma companies, health authorities and governments are also taking steps to reduce drug shortages. FDA is working closely with five cancer drug manufacturers to increase production capacities. It has also facilitated the re-entry of a previously discontinued cisplatin product into the market.On the legislative front, the US Senate Finance Committee has proposed a draft of a policy that would incentivize generic drug manufacturers to prioritize production of essential medications. These incentives include minimum three-year contracts with stable pricing, contingency contracts with alternate manufacturers, transparency in quality control issues, and modifications to the Medicaid Drug Rebate Program. France, like most European nations, is also facing shortages of medicines like insulin and anti-cancer drugs. But most problematic are its shortages of antibiotics, paracetamol and corticoids. The French government has introduced a new three-year "roadmap" (from 2024 to 2027) to address these shortages. A significant step in this direction is the planned opening of the first European paracetamol factory in Toulouse in 2025, which will help reduce Europe’s dependence on China, India, and the US for this widely used medication.View Our Interactive Dashboard on Drug Shortages So Far in 2024 (Free Excel Available) Our viewThe global drug shortages underscore the fragility of pharmaceutical supply chains and the urgent need for reform. Longstanding drug shortages, particularly those affecting cancer treatments, antibiotics, and essential medications often stem from the low profitability of generic drugs.While investments in manufacturing capacity and regulatory measures are steps in the right direction, a more comprehensive, concerted global approach is needed to resolve the deep-seated systemic issues in the pharmaceutical industry.  
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    Methylphenidate HCl

    Drug Cost (USD) : 50,133

    Year : 2022

    Prescribers : 41

    Prescriptions : 205

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    Methylphenidate HCl

    Drug Cost (USD) : 6,601,902

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    Drug Cost (USD) : 708,936

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    Prescribers : 240

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    Drug Cost (USD) : 2,538

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    Prescriptions : 17

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    Methylphenidate HCl

    Drug Cost (USD) : 21,091,777

    Year : 2022

    Prescribers : 99305

    Prescriptions : 585567

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    Methylphenidate HCl

    Drug Cost (USD) : 201,077

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    Prescribers : 64

    Prescriptions : 414

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    Methylphenidate HCl

    Drug Cost (USD) : 159,626

    Year : 2022

    Prescribers : 51

    Prescriptions : 244

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    Methylphenidate HCl

    Drug Cost (USD) : 914,489

    Year : 2022

    Prescribers : 1107

    Prescriptions : 7282

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    Methylphenidate HCl

    Drug Cost (USD) : 1,030,144

    Year : 2022

    Prescribers : 287

    Prescriptions : 1821

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    Methylphenidate HCl

    Drug Cost (USD) : 82,078

    Year : 2021

    Prescribers : 50

    Prescriptions : 271

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    Brand Name : METHYLPHENIDATE HYDROCHLORID...

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    BARR LABS INC

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 20MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : DISCN

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    BARR LABS INC

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 30MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : DISCN

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    BARR LABS INC

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 40MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : DISCN

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    BARR LABS INC

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : DISCN

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    SANDOZ

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 20MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : RX

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    SANDOZ

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 30MG

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    Published in :

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    RX/OTC/DISCN : RX

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    SANDOZ

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 40MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : RX

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    SANDOZ

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : RX

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    SANDOZ

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 60MG **Federal Register determination that...

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : DISCN

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    Brand Name : METHYLPHENIDATE HYDROCHLORID...

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    TEVA PHARMS

    Methylphenidate Hydrochloride

    Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

    Dosage Strength : 10MG

    Price Per Pack :

    Published in :

    Country : USA

    RX/OTC/DISCN : RX

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    Brand Name : Methylphenidate Er

    Methylphenidate Hydrochloride

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    Brand Name : Methylphenidate Er

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    Mallinckrodt Plc

    Methylphenidate Hydrochloride

    Main Therapeutic Indication : Neurological/Mental Disorders

    Currency : USD

    2016 Revenue in Millions : 104

    2015 Revenue in Millions : 137

    Growth (%) : -24

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    Brand Name : Methylphenidate ER

    Methylphenidate Hydrochloride

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    Brand Name : Methylphenidate ER

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    Mallinckrodt Plc

    Methylphenidate Hydrochloride

    Main Therapeutic Indication : Neurological/Mental Disorders

    Currency : USD

    2017 Revenue in Millions : 72

    2016 Revenue in Millions : 126

    Growth (%) : -43

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    ABOUT THIS PAGE

    Methylphenidate Hydrochloride Manufacturers

    A Methylphenidate Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylphenidate Hydrochloride, including repackagers and relabelers. The FDA regulates Methylphenidate Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylphenidate Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Methylphenidate Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Methylphenidate Hydrochloride Suppliers

    A Methylphenidate Hydrochloride supplier is an individual or a company that provides Methylphenidate Hydrochloride active pharmaceutical ingredient (API) or Methylphenidate Hydrochloride finished formulations upon request. The Methylphenidate Hydrochloride suppliers may include Methylphenidate Hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Methylphenidate Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Methylphenidate Hydrochloride USDMF

    A Methylphenidate Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylphenidate Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Methylphenidate Hydrochloride DMFs exist exist since differing nations have different regulations, such as Methylphenidate Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Methylphenidate Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Methylphenidate Hydrochloride USDMF includes data on Methylphenidate Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylphenidate Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Methylphenidate Hydrochloride suppliers with USDMF on PharmaCompass.

    Methylphenidate Hydrochloride JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Methylphenidate Hydrochloride Drug Master File in Japan (Methylphenidate Hydrochloride JDMF) empowers Methylphenidate Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Methylphenidate Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Methylphenidate Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Methylphenidate Hydrochloride suppliers with JDMF on PharmaCompass.

    Methylphenidate Hydrochloride KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Methylphenidate Hydrochloride Drug Master File in Korea (Methylphenidate Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Methylphenidate Hydrochloride. The MFDS reviews the Methylphenidate Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Methylphenidate Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Methylphenidate Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Methylphenidate Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Methylphenidate Hydrochloride suppliers with KDMF on PharmaCompass.

    Methylphenidate Hydrochloride CEP

    A Methylphenidate Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Methylphenidate Hydrochloride Certificate of Suitability (COS). The purpose of a Methylphenidate Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Methylphenidate Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Methylphenidate Hydrochloride to their clients by showing that a Methylphenidate Hydrochloride CEP has been issued for it. The manufacturer submits a Methylphenidate Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Methylphenidate Hydrochloride CEP holder for the record. Additionally, the data presented in the Methylphenidate Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Methylphenidate Hydrochloride DMF.

    A Methylphenidate Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Methylphenidate Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Methylphenidate Hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Methylphenidate Hydrochloride WC

    A Methylphenidate Hydrochloride written confirmation (Methylphenidate Hydrochloride WC) is an official document issued by a regulatory agency to a Methylphenidate Hydrochloride manufacturer, verifying that the manufacturing facility of a Methylphenidate Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methylphenidate Hydrochloride APIs or Methylphenidate Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Methylphenidate Hydrochloride WC (written confirmation) as part of the regulatory process.

    click here to find a list of Methylphenidate Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Methylphenidate Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Methylphenidate Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Methylphenidate Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Methylphenidate Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Methylphenidate Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methylphenidate Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Methylphenidate Hydrochloride suppliers with NDC on PharmaCompass.

    Methylphenidate Hydrochloride GMP

    Methylphenidate Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Methylphenidate Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Methylphenidate Hydrochloride GMP manufacturer or Methylphenidate Hydrochloride GMP API supplier for your needs.

    Methylphenidate Hydrochloride CoA

    A Methylphenidate Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Methylphenidate Hydrochloride's compliance with Methylphenidate Hydrochloride specifications and serves as a tool for batch-level quality control.

    Methylphenidate Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Methylphenidate Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Methylphenidate Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Methylphenidate Hydrochloride EP), Methylphenidate Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methylphenidate Hydrochloride USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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