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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 20 USDMF, 16 CEP/COS, 1 JDMF, 6 EU WC, 8 KDMF, 22 NDC API, 18 Listed Suppliers, $ API Reference Price

36 API Suppliers
20 USDMF
16 CEP/COS
1 JDMF
6 EU WC
8 KDMF
22 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

608 FDF Dossiers, 262 FDA Orange Book, 232 Europe, 52 Canada, 30 South Africa, 32 Listed Dossiers

608 FDF Dossiers
262 FDA Orange Book
232 Europe
52 Canada
30 South Africa
32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG, TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG, TABLET, EXTENDED RELEASE;ORAL - 18MG, TABLET, EXTENDED RELEASE;ORAL - 27MG, TABLET, EXTENDED RELEASE;ORAL - 36MG, TABLET, EXTENDED RELEASE;ORAL - 54MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, CAPSULE, EXTENDED RELEASE;ORAL - 60MG, SOLUTION;ORAL - 10MG/5ML, SOLUTION;ORAL - 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET;ORAL - 10MG
TABLET;ORAL - 20MG
TABLET;ORAL - 5MG
TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML
CAPSULE, EXTENDED RELEASE;ORAL - 10MG
CAPSULE, EXTENDED RELEASE;ORAL - 15MG
CAPSULE, EXTENDED RELEASE;ORAL - 20MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG
CAPSULE, EXTENDED RELEASE;ORAL - 40MG
CAPSULE, EXTENDED RELEASE;ORAL - 50MG
CAPSULE, EXTENDED RELEASE;ORAL - 60MG
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 20MG
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 30MG
TABLET, EXTENDED RELEASE, CHEWABLE;ORAL - 40MG
TABLET, EXTENDED RELEASE;ORAL - 18MG
TABLET, EXTENDED RELEASE;ORAL - 27MG
TABLET, EXTENDED RELEASE;ORAL - 36MG
TABLET, EXTENDED RELEASE;ORAL - 54MG
CAPSULE, EXTENDED RELEASE;ORAL - 10MG
CAPSULE, EXTENDED RELEASE;ORAL - 20MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG
CAPSULE, EXTENDED RELEASE;ORAL - 40MG
CAPSULE, EXTENDED RELEASE;ORAL - 50MG
CAPSULE, EXTENDED RELEASE;ORAL - 60MG
SOLUTION;ORAL - 10MG/5ML
SOLUTION;ORAL - 5MG/5ML
TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 8 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 18 DKSH, 1 Jai Radhe Sales, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 3 Pfanstiehl, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 20 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 2 Hayashibara, 15 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 36 Roquette, 9 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 6 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 2 Zhejiang Huakang Pharmaceutical

relatedExcipients
1 Minakem
3 Evonik
8 Rochem International Inc
19 SPI Pharma
2 Seqens
18 DKSH
1 Jai Radhe Sales
2 Pharm-RX Chemical
1 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
15 Gangwal Healthcare
10 Nanjing Well Pharmaceutical
3 Pfanstiehl
4 ACG Worldwide
12 Actylis
1 Aeon Procare
2 Alcedo Pharmachem
8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
38 BASF
1 Bioplus Life Sciences
20 Corel Pharma Chem
6 DFE Pharma
2 Finar
11 Gangwal Chemicals
2 Hayashibara
15 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
39 Kerry
5 Kima Chemical
6 Lonza Capsugel
20 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
3 Novo Excipients
4 Pharmatrans-Sanaq
9 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
36 Roquette
9 Seppic
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
6 The Dow Chemical Company
1 Ulanqab Kema New Material
2 Valens Pharmachem
3 Vasa Pharmachem
3 Vertellus
2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 84 Coating Systems & Additives, 54 Controlled & Modified Release, 50 Thickeners and Stabilizers, 46 Direct Compression, 37 Taste Masking, 32 Solubilizers, 30 Film Formers & Plasticizers, 30 Granulation, 28 Disintegrants & Superdisintegrants, 27 Topical, 27 Parenteral, 27 Lubricants & Glidants, 22 Chewable & Orodispersible Aids, 18 Co-Processed Excipients, 10 Emulsifying Agents, 9 Empty Capsules, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 70 NEWS #PharmaBuzz

media
5 DATA COMPILATION #PharmaFlow
70 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 150 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
9 US Medicaid Prescriptions
150 Finished Drug Prices
1 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

marketPlace
10 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

191 US Patents, 6 US Exclusivities, 25 Health Canada Patents

patents
191 US Patents
6 US Exclusivities
25 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 2 USP , 3 Others

otherSolutions
3 EDQM
2 USP
3 Others

Veranova Methylphenidate Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

Listed Suppliers

API REF. PRICE (USD/KG)

$ 783

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

608

FDF Dossiers

262

FDA Orange Book

232

Europe

Canada

Australia

South Africa

Listed Dossiers

12DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

191

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

30,760,622

Annual Reports (USD Million)

Finished Drug Prices

387 RELATED EXCIPIENT COMPANIES

670EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown

Click the button for full data set

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

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 Formula	C₁₄H₂₀ClNO₂
Molecular Weight	269.77 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	269.1182566 g/mol
Monoisotopic Mass	269.1182566 g/mol
Topological Polar Surface Area	38.3 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	249
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 16
Drug Name	Concerta
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	CONCERTA 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	54mg; 18mg; 27mg; 36mg
Market Status	Prescription
Company	Janssen Pharms

2 of 16
Drug Name	Metadate cd
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 50mg; 60mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ucb

3 of 16
Drug Name	Metadate er
PubMed Health	Methylphenidate (By mouth)
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	20mg
Market Status	Prescription
Company	Ucb

4 of 16
Drug Name	Methylin er
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	Methylphenidate 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	10mg; 20mg
Market Status	Prescription
Company	Mallinckrodt

5 of 16
Drug Name	Methylphenidate hydrochloride
Drug Label	Methylphenidate 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule, extended release; Solution
Route	oral; Oral
Strength	10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; 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 Name	Quillivant xr
Drug Label	QUILLIVANT 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	For suspension, extended release
Route	Oral
Strength	5mg/ml
Market Status	Prescription
Company	Nextwave Pharms

7 of 16
Drug Name	Ritalin
Drug Label	Ritalin 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg; 20mg
Market Status	Prescription
Company	Novartis

8 of 16
Drug Name	Ritalin la
Drug Label	Methylphenidate 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Novartis

9 of 16
Drug Name	Concerta
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	CONCERTA 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	54mg; 18mg; 27mg; 36mg
Market Status	Prescription
Company	Janssen Pharms

10 of 16
Drug Name	Metadate cd
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 50mg; 60mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Ucb

11 of 16
Drug Name	Metadate er
PubMed Health	Methylphenidate (By mouth)
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	METADATE 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	20mg
Market Status	Prescription
Company	Ucb

12 of 16
Drug Name	Methylin er
PubMed Health	Methylphenidate
Drug Classes	CNS Stimulant, Central Nervous System Agent
Drug Label	Methylphenidate 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release
Route	Oral
Strength	10mg; 20mg
Market Status	Prescription
Company	Mallinckrodt

13 of 16
Drug Name	Methylphenidate hydrochloride
Drug Label	Methylphenidate 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet, extended release; Tablet; Capsule, extended release; Solution
Route	oral; Oral
Strength	10mg/5ml; 18mg; 30mg; 27mg; 36mg; 5mg; 54mg; 50mg; 60mg; 10mg; 5mg/5ml; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Corepharma; 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 Name	Quillivant xr
Drug Label	QUILLIVANT 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	For suspension, extended release
Route	Oral
Strength	5mg/ml
Market Status	Prescription
Company	Nextwave Pharms

15 of 16
Drug Name	Ritalin
Drug Label	Ritalin 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg; 20mg
Market Status	Prescription
Company	Novartis

16 of 16
Drug Name	Ritalin la
Drug Label	Methylphenidate 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 Ingredient	Methylphenidate hydrochloride
Dosage Form	Capsule, extended release
Route	Oral
Strength	30mg; 10mg; 40mg; 20mg
Market Status	Prescription
Company	Novartis

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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API Reference Price

[{"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. SOCIETY,ROAD NO.2","city":"BANJARA HILLS HYDERABAD,TELANGANA","supplier":"HRV GLOBAL LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"TEHRAN","customer":"VANA DAROU GOSTAR ","customerCountry":"IRAN","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"1063","totalValueFC":"52598.6","currency":"USD","unitRateINR":76590.551800000001,"date":"16-Feb-2021","totalValueINR":"3829527.59","totalValueInUsd":"52598.6","indian_port":"HYDERABAD AIR","hs_no":"29333300","bill_no":"8678532","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"IRAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO. 4,WOMENS,S CO-OP. SOCIETY,ROAD NO.2, BANJARA HILLS HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q2","strtotime":1624473000,"product":"METHYLPHENIDATE HYDROCHLORIDE USP (LUT A RN NO. - AD240321024334R DATE - 24\/03\/20 21)","address":"ACME PLAZA, ANDHERI KURLA ROAD,ANDHERI EAST","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"APOTEX INC","customerCountry":"CANADA","quantity":"172.52","actualQuantity":"172.52","unit":"KGS","unitRateFc":"590.3","totalValueFC":"99767.5","currency":"USD","unitRateINR":42531.084164154876,"date":"24-Jun-2021","totalValueINR":"7337462.64","totalValueInUsd":"99767.5","indian_port":"BOMBAY AIR","hs_no":"29333300","bill_no":"2637353","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,ANDHERI EAST, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699036200,"product":"METHYLPHENIDATE HYDROCHLORIDE(E\/AUTH.P-EXP-14808\/2023.F. XVI\/4\/4578\/TECH\/PSY\/2023 DT.18.10.23,I\/CERT. 39320 DT.13.09.","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"HARMAN FINOCHEM","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"TO ORDER","customerCountry":"GREECE","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"980","totalValueFC":"1770.2","currency":"USD","unitRateINR":73500,"date":"04-Nov-2023","totalValueINR":"147000","totalValueInUsd":"1770.2","indian_port":"Bombay Air","hs_no":"29333400","bill_no":"5139337","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712169000,"product":"HSN CODE 29333323 ITEM CODE 2021237 HARMLESS PHARMACEUTICAL BULK DRUG METHYLPHENIDATE HYDROCHLORIDE PH. EUR.","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":"160311.3","currency":"USD","unitRateINR":41602.120000000003,"date":"04-Apr-2024","totalValueINR":"13312678.4","totalValueInUsd":"160311.3","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"8899561","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":"Q2","strtotime":1715279400,"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":"160356.9","currency":"USD","unitRateINR":41613.959625000003,"date":"10-May-2024","totalValueINR":"13316467.08","totalValueInUsd":"160356.9","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"9787682","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 10187

DOSAGE - TABLET;ORAL - 20MG

USFDA APPLICATION NUMBER - 10187

DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 10187

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

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

USFDA APPLICATION NUMBER - 202100

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