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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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    DMF Number : 19547

    Submission : 2006-06-26

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2009-078 - Rev 00

    Issue Date : 2015-01-27

    Type : Chemical

    Substance Number : 2235

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49812-0020

    Start Marketing Date : 2010-06-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Hwanin Pharmaceutical Co., Ltd.

    Registration Date : 2021-12-17

    Registration Number : 20210427-209-J-837(1)

    Manufacturer Name : Macfarlan Smith Limited@Macfarlan Smith Limited

    Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom@Three Trees Road, Newbie, Annan, DG12 5QH, United Kingdom

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    Available Reg Filing : ROW
    AUDIT
    Veranova

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    09

    Noramco

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-07

    Pay. Date : 2013-07-19

    DMF Number : 27208

    Submission : 2013-07-12

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51634-0114

    Start Marketing Date : 2017-07-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Noramco

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    10

    Noramco

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-09-19

    Pay. Date : 2015-09-15

    DMF Number : 29411

    Submission : 2016-05-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 51634-0114

    Start Marketing Date : 2017-07-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Noramco

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    Veranova Lp

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10137

    Submission : 1993-03-05

    Status : Active

    Type : II

    Veranova

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    02

    Veranova Lp

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

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-31

    Pay. Date : 2013-01-07

    DMF Number : 19547

    Submission : 2006-06-26

    Status : Active

    Type : II

    Veranova

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    03

    Noramco Llc

    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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    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-09-19

    Pay. Date : 2015-09-15

    DMF Number : 29411

    Submission : 2016-05-27

    Status : Active

    Type : II

    Noramco

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    04

    Noramco Llc

    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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    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-07-07

    Pay. Date : 2013-07-19

    DMF Number : 27208

    Submission : 2013-07-12

    Status : Active

    Type : II

    Noramco

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    05

    Noramco Llc

    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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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-03-27

    Pay. Date : 2012-11-23

    DMF Number : 22244

    Submission : 2008-12-19

    Status : Active

    Type : II

    Noramco

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    06

    Medlab Asia & Asia Health
    Not Confirmed

    06

    Boehringer Ingelheim Chemicals Inc

    Germany
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15485

    Submission : 2001-06-20

    Status : Inactive

    Type : II

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    07

    Chattem Chemicals Inc

    U.S.A

    USDMF

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    Not Confirmed

    07

    Chattem Chemicals Inc

    U.S.A
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    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-04

    Pay. Date : 2012-11-16

    DMF Number : 16331

    Submission : 2002-12-20

    Status : Active

    Type : II

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    08

    Specgx Llc

    Ireland

    USDMF

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    Not Confirmed

    08

    Specgx Llc

    Ireland
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    Medlab Asia & Asia Health
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-02-08

    Pay. Date : 2012-11-27

    DMF Number : 12769

    Submission : 1997-11-25

    Status : Active

    Type : II

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    09

    Medlab Asia & Asia Health
    Not Confirmed

    09

    Ciba Geigy Corp Pharmaceutical Divis...

    Switzerland
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 4599

    Submission : 1982-06-16

    Status : Inactive

    Type : II

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    10

    Siegfried Usa Llc

    Switzerland

    USDMF

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    Not Confirmed

    10

    Siegfried Usa Llc

    Switzerland
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    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12989

    Submission : 1998-05-15

    Status : Inactive

    Type : II

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    Macfarlan Smith Limited

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

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    Methylphenidate hydrochloride

    Registration Number : 302MF10009

    Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom

    Initial Date of Registration : 2020-01-17

    Latest Date of Registration : 2020-01-17

    Veranova

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    01

    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 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...

    Cohance

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    02

    Harman Finochem

    India
    CPHI Middle east
    Not Confirmed
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    Harman Finochem

    India
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    Not Confirmed
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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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    03

    Ipca Laboratories

    India
    CPHI Middle east
    Not Confirmed
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    04

    Sriam Labs

    India
    CPHI Middle east
    Not Confirmed
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    Sriam Labs

    India
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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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    Sriam Labs

    India
    CPHI Middle east
    Not Confirmed
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    Sriam Labs

    India
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    CPHI Middle east
    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
    CPHI Middle east
    Not Confirmed
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    Sun Pharmaceutical Industries Limited

    India
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    Not Confirmed
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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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    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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    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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    HRV Global Life Sciences

    India
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    Attending
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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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    Centaur Pharmaceuticals

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Centaur Pharmaceuticals

    India
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    Methylphenidate HCl

    About the Company : Centaur accepts change as a constant, and continuously innovates to remain significant. Centaur has built knowledge sharing relationships with the pharmaceutical majors in areas of...

    Centaur accepts change as a constant, and continuously innovates to remain significant. Centaur has built knowledge sharing relationships with the pharmaceutical majors in areas of product development, custom synthesis, contract research and contract manufacturing. Centaur formulations and API are exported across 5 continents and more than 60 countries including regulated markets. Formulations Centaur ranks among India's TOP 50 pharmaceutical companies by prescriptions (CMarc) and by stockist audit (ORG-IMS). Centaur's All-India network includes a 1000 strong sales force that covers 250,000 doctors and 250,000 retailers every month.
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    Ipca Laboratories

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Ipca Laboratories

    India
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    Methylphenidate Hydrochloride

    About the Company : Ipca Laboratories, headquartered in Mumbai, India, is a prominent pharmaceutical enterprise established in 1949. Over the years, Ipca has emerged as a leading player in India's pha...

    Ipca Laboratories, headquartered in Mumbai, India, is a prominent pharmaceutical enterprise established in 1949. Over the years, Ipca has emerged as a leading player in India's pharmaceutical landscape, specializing in the manufacturing and commercialization of a diverse range of healthcare products, including APIs, formulations, and generic drugs. Renowned for its exceptional research and development capabilities, Ipca is dedicated to delivering high-quality and cost-effective medications across various therapeutic domains, including anti-malarial, anti-infective, anti-inflammatory, cardiovascular, central nervous system, among others.
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    Resonance Laboratories Pvt. Ltd

    India
    Medlab Asia & Asia Health
    Not Confirmed
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    Resonance Laboratories Pvt. Ltd

    India
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    Methylphenidate Hydrochloride

    About the Company : Resonance has been a presence in the API and Specialty Chemicals segment for more than 30 years. After a start in Mumbai, operations moved to Bangalore in 1984. In the 30 years, Re...

    Resonance has been a presence in the API and Specialty Chemicals segment for more than 30 years. After a start in Mumbai, operations moved to Bangalore in 1984. In the 30 years, Resonance has partnered with several multinationals on custom synthesis projects and with our strengths in multi-step synthesis together with focus on quality, we have helped our customers develop their products in a timely fashion. We have brought the same discipline to our API business and in the recent years have developed some complex molecules that are produced in our cGMP plant. Our facility is WHO GMP certified and we follow cGMP as per the ICH Q7 guideline.We have registered DMFs and CEPs for some of our products and are in the process of registering more. We currently sell to the European and other markets on the basis of our DMFs and CEPs.
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1612377000,"product":"METHYLPHENIDATE HYDROCHLORIDE PH.EUR. - BULK DRUG *EXPORT PERMIT NO:P-EXP-15498\/ 2020 DT. 07.12.2020","address":"ACME PLAZA, ANDHERI KURLA ROAD,ANDHERI EAST","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"INDIA","foreign_port":"ZURICH","customer":"DEVELCO PHARMA SCHWEIZ ","customerCountry":"SWITZERLAND","quantity":"160.00","actualQuantity":"160","unit":"KGS","unitRateFc":"660.1","totalValueFC":"104523.2","currency":"USD","unitRateINR":47562.449999999997,"date":"04-Feb-2021","totalValueINR":"7609992","totalValueInUsd":"104523.2","indian_port":"BOMBAY AIR","hs_no":"29333300","bill_no":"8402354","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,ANDHERI EAST, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","year":"2021","qtr":"Q1","strtotime":1613413800,"product":"METHYLPHENIDATE HYDROCHLORIDE (USP) (VID E EXPORT AUTHORIZATION NO.P-EXP-15943\/20 20 DATED 31.12.2020.)","address":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO. 4,WOMENS,S CO-OP. 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LTD","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"500","totalValueFC":"250.5","currency":"USD","unitRateINR":"41225","date":"15-Oct-2022","totalValueINR":"20612.5","totalValueInUsd":"250.5","indian_port":"BOMBAY AIR","hs_no":"29333323","bill_no":"2902228","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"UNIT NO201-204,MAROL,BEHIND MITTAL INDS.COM.GAYATRI COMMERCIAL COMPLEX"}]
    04-Feb-2021
    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

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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

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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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    02

    Ironshore Pharmaceuticals

    U.S.A
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    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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    03

    Ironshore Pharmaceuticals

    U.S.A
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    Ironshore Pharmaceuticals

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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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    Alora Pharmaceuticals

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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

    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

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    Tris Pharma Inc

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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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    Tris Pharma Inc

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    Tris Pharma Inc

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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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    Brand Institute

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    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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    InfectoPharm Drugs and Consilium

    Germany
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    Not Confirmed

    InfectoPharm Drugs and Consilium

    Germany
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    Not Confirmed
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    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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    09

    Societal CDMO

    U.S.A
    arrow
    CPHI Middle east
    Not Confirmed

    Societal CDMO

    U.S.A
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
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    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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    FDA Approves Supplemental New Drug Application for Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII

    Details:

    The sNDA approval was based on data from a randomized, double-blind, parallel-group, placebo-controlled, Phase 3 Adult Laboratory Classroom (ALC) study evaluating the safety and efficacy of Adhansia XR in adult patients diagnosed with ADHD.


    Lead Product(s): Methylphenidate Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Adhansia XR

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 01, 2021

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    10

    Adlon Therapeutics

    U.S.A
    arrow
    CPHI Middle east
    Not Confirmed

    Adlon Therapeutics

    U.S.A
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
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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

    FDA Approves Supplemental New Drug Application for Adhansia XR® (methylphenidate HCl) Extended-Re...

    Details : The sNDA approval was based on data from a randomized, double-blind, parallel-group, placebo-controlled, Phase 3 Adult Laboratory Classroom (ALC) study evaluating the safety and efficacy of Adhansia XR in adult patients diagnosed with ADHD.

    Brand Name : Adhansia XR

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 01, 2021

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    01

    Cohance Lifesciences

    India
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    Medlab Asia & Asia Health
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    • fda
    • EDQM
    • WHO-GMP

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

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    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

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    02

    Cohance Lifesciences

    India
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
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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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    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

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    Cohance Lifesciences

    India
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    Medlab Asia & Asia Health
    Not Confirmed
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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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    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

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    04

    Cohance Lifesciences

    India
    arrow
    Medlab Asia & Asia Health
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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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    Virtual Booth Virtual Booth
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    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

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    05

    Cohance Lifesciences

    India
    arrow
    Medlab Asia & Asia Health
    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.

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    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

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    06

    Dr. Reddy's Laboratories

    India
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    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

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    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
    arrow
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

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

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    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
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • 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
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    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
    Medlab Asia & Asia Health
    Not Confirmed
    • 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
    Medlab Asia & Asia Health
    Not Confirmed
    • fda
    • EDQM
    • 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 : 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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    Product Web Link

    Virtual Booth

    Digital Content

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    Corporate PDF

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    Europe

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    01

    2care4 ApS

    Denmark
    CPHI Middle east
    Not Confirmed
    arrow

    2care4 ApS

    Denmark
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
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    • WHO-GMP
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Norway

    Methylphenidate hydrochloride

    Brand Name : Methylphenidate Aurora Medical

    Dosage Form : Tablet

    Dosage Strength : 10 mg

    Packaging : Blisterpakning 195item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    02

    Medice Arzneimittel P?tter GmbH & Co KG

    Germany
    CPHI Middle east
    Not Confirmed
    arrow

    Medice Arzneimittel P?tter GmbH & Co KG

    Germany
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Norway

    Methylphenidate hydrochloride

    Brand Name : Medikinet

    Dosage Form : Tablet

    Dosage Strength : 10 mg

    Packaging : Blisterpakning 100item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    Mepha Pharma AG

    Switzerland
    CPHI Middle east
    Not Confirmed
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    Mepha Pharma AG

    Switzerland
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Switzerland

    Methylphenidate hydrochloride

    Brand Name : Methylphenidat-Mepha LA

    Dosage Form : Depocaps

    Dosage Strength : 40mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    04

    Orifarm AB

    Denmark
    CPHI Middle east
    Not Confirmed
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    Orifarm AB

    Denmark
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    CPHI Middle east
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Sweden

    methylphenidate hydrochloride

    Brand Name : Concerta

    Dosage Form : PROLONGED-RELEASE TABLET

    Dosage Strength : 18 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    05

    Salmon Pharma GmbH

    Switzerland
    CPHI Middle east
    Not Confirmed
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    Salmon Pharma GmbH

    Switzerland
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    CPHI Middle east
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Switzerland

    Methylphenidate hydrochloride

    Brand Name : Medikinet MR

    Dosage Form : Kaps

    Dosage Strength : 40mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    06

    Sandoz Pharmaceuticals AG

    Switzerland
    CPHI Middle east
    Not Confirmed
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    Sandoz Pharmaceuticals AG

    Switzerland
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    CPHI Middle east
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Methylphenidate hydrochloride

    Brand Name : Methylphenidate Sandoz

    Dosage Form : Ret Tabl

    Dosage Strength : 18mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    Takeda Pharmaceuticals International AG ...

    Japan
    CPHI Middle east
    Not Confirmed
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    Takeda Pharmaceuticals International AG ...

    Japan
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    Not Confirmed
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    Registration Country : Norway

    Methylphenidate hydrochloride

    Brand Name : Equasym Depot

    Dosage Form : Kapsel med modifisert frisetting, hard

    Dosage Strength : 20 mg

    Packaging : Blisterpakning 30item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Takeda Pharmaceuticals International AG ...

    Japan
    CPHI Middle east
    Not Confirmed
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    Takeda Pharmaceuticals International AG ...

    Japan
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    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Methylphenidate hydrochloride

    Brand Name : Equasym Depot

    Dosage Form : Kapsel med modifisert frisetting, hard

    Dosage Strength : 30 mg

    Packaging : Blisterpakning 30item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    09

    Takeda Pharma AG

    Japan
    CPHI Middle east
    Not Confirmed
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    Takeda Pharma AG

    Japan
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    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Methylphenidate hydrochloride

    Brand Name : Equasym XR

    Dosage Form : Straight Cap

    Dosage Strength : 10mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    10

    2care4 ApS

    Country
    CPHI Middle east
    Not Confirmed
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    2care4 ApS

    Country
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    CPHI Middle east
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Sweden

    metylfenidathydroklorid

    Brand Name : Medikinet

    Dosage Form : KAPSEL MED MODIFIERAD FRISÄTTNING, HÅRD

    Dosage Strength : 40 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Canada

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    01

    APOTEX INC

    Canada
    Medlab Asia & Asia Health
    Not Confirmed
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    APOTEX INC

    Canada
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    Medlab Asia & Asia Health
    Not Confirmed
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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : APO-METHYLPHENIDATE

    Dosage Form : TABLET

    Dosage Strength : 20MG

    Packaging : 100

    Approval Date :

    Application Number : 2249332

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    APOTEX INC

    Canada
    Medlab Asia & Asia Health
    Not Confirmed
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    APOTEX INC

    Canada
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    Not Confirmed
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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : APO-METHYLPHENIDATE

    Dosage Form : TABLET

    Dosage Strength : 5MG

    Packaging : 100

    Approval Date :

    Application Number : 2273950

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    03

    ELVIUM LIFE SCIENCES

    Canada
    Medlab Asia & Asia Health
    Not Confirmed
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    ELVIUM LIFE SCIENCES

    Canada
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    Medlab Asia & Asia Health
    Not Confirmed
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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : BIPHENTIN

    Dosage Form : CAPSULE (EXTENDED RELEASE)

    Dosage Strength : 15MG

    Packaging : 100

    Approval Date :

    Application Number : 2277131

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    ELVIUM LIFE SCIENCES

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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : BIPHENTIN

    Dosage Form : CAPSULE (EXTENDED RELEASE)

    Dosage Strength : 20MG

    Packaging : 100

    Approval Date :

    Application Number : 2277158

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    ELVIUM LIFE SCIENCES

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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : BIPHENTIN

    Dosage Form : CAPSULE (EXTENDED RELEASE)

    Dosage Strength : 80MG

    Packaging : 50

    Approval Date :

    Application Number : 2277212

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    ELVIUM LIFE SCIENCES

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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : FOQUEST

    Dosage Form : CAPSULE (CONTROLLED RELEASE)

    Dosage Strength : 55MG

    Packaging : 60

    Approval Date :

    Application Number : 2470322

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    07

    Pharmascience Inc.

    Canada
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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    Methylphenidate Hydrochloride

    Brand Name : PMS-METHYLPHENIDATE ER

    Dosage Form : TABLET (EXTENDED-RELEASE)

    Dosage Strength : 27MG

    Packaging : 100

    Approval Date :

    Application Number :

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    PHARMASCIENCE INC

    Canada
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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : PMS-METHYLPHENIDATE CR

    Dosage Form : CAPSULE (EXTENDED RELEASE)

    Dosage Strength : 30MG

    Packaging :

    Approval Date :

    Application Number : 2536986

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    09

    PHARMASCIENCE INC

    Canada
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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : PMS-METHYLPHENIDATE CR

    Dosage Form : CAPSULE (EXTENDED RELEASE)

    Dosage Strength : 40MG

    Packaging :

    Approval Date :

    Application Number : 2536994

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    10

    TEVA CANADA LIMITED

    Israel
    Medlab Asia & Asia Health
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    Israel
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    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

    METHYLPHENIDATE HYDROCHLORIDE

    Brand Name : ACT METHYLPHENIDATE ER

    Dosage Form : TABLET (EXTENDED-RELEASE)

    Dosage Strength : 27MG

    Packaging : 100

    Approval Date :

    Application Number : 2441942

    Regulatory Info : Schedule G (CDSA III)

    Registration Country : Canada

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    DRUG PRODUCT COMPOSITIONS

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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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