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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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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

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Methylphenidate Hydrochloride EP/USP

Date of Issue : 2022-08-25

Valid Till : 2025-07-02

Written Confirmation Number : WC-0195

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

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methyl phenidate hcl EP/USP

Date of Issue : 2022-06-08

Valid Till : 2025-07-21

Written Confirmation Number : WC-0045nA2

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

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Sriam Labs

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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

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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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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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01

Veranova

U.S.A
  • fda
  • EDQM
  • WHO-GMP

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

02

SCI Pharmtech

Taiwan
  • fda
  • EDQM
  • WHO-GMP

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

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Methylphenidate Hydrochloride

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

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

  • 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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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

04

  • fda
  • EDQM
  • WHO-GMP

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

05

  • fda
  • EDQM
  • WHO-GMP

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

06

Noramco

U.S.A
  • fda
  • EDQM
  • WHO-GMP

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

07

AMWC Asia-TDAC
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AMWC Asia-TDAC
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Methylphenidate Hydrochloride

About the Company : Back in the year 1973, a team of individuals came up with such an idea – The idea called Alkem. Looking back at our 5 decades, illustrious journey, that one small idea has Not on...

Back in the year 1973, a team of individuals came up with such an idea – The idea called Alkem. Looking back at our 5 decades, illustrious journey, that one small idea has Not only triggered us to become one of India’s largest generic and specialty pharmaceutical company but also, create a foothold in over 40 countries. 29% of our revenue is generated via offshore sales and it has consistently been ranked amongst the top ten pharmaceutical companies in India. They have 20 manufacturing facilities at multiple locations in India and the United States of America.
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08

AMWC Asia-TDAC
Not Confirmed
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Methylphenidate Hydrochloride

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. 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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09

AMWC Asia-TDAC
Not Confirmed
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Methylphenidate Hydrochloride

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

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

AMWC Asia-TDAC
Not Confirmed
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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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API Reference Price

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16-Feb-2021
29-Mar-2025
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Drugs in Development

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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: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 09, 2020

Dr Reddy Company Banner

01

Lead Product(s) : Methylphenidate Hydrochloride

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

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.

Product Name : Methylphenidate Hydrochloride-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 09, 2020

Dr Reddy Company Banner

Details:

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


Lead Product(s): Methylphenidate Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Quillivant XR

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 19, 2024

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02

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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

Product Name : Quillivant XR

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 19, 2024

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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: Approved FDFProduct Type: Other 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

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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.

Product Name : Jornay PM

Product Type : Other Small Molecule

Upfront Cash : $525.0 million

July 29, 2024

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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: Approved FDFProduct Type: Other Small Molecule

Sponsor: Collegium Pharmaceutical

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

Deal Type: Acquisition April 09, 2024

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04

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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.

Product Name : Jornay PM

Product Type : Other Small Molecule

Upfront Cash : $525.0 million

April 09, 2024

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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: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 19, 2023

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05

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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.

Product Name : Relexxii

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 19, 2023

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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 XR

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 25, 2023

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06

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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.

Product Name : Quillivant XR

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 25, 2023

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  • Development Update

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: Approved FDFProduct Type: Other Small Molecule

Sponsor: Osmotica Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 07, 2022

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07

Brand Institute

Country
arrow
AMWC Asia-TDAC
Not Confirmed

Brand Institute

Country
arrow
AMWC Asia-TDAC
Not Confirmed

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.

Product Name : Relexxii

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 07, 2022

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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: Quillivant XR

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Teva Pharmaceutical Industries

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 18, 2022

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08

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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.

Product Name : Quillivant XR

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 18, 2022

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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: Approved FDFProduct Type: Other Small Molecule

Sponsor: InfectoPharm Drugs and Consilium

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 05, 2022

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09

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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.

Product Name : Ritalin LA

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

May 05, 2022

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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: Approved FDFProduct Type: Other Small Molecule

Sponsor: Societal CDMO

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement May 05, 2022

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10

AMWC Asia-TDAC
Not Confirmed
AMWC Asia-TDAC
Not Confirmed

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...

Product Name : Ritalin LA

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

May 05, 2022

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FDA Orange Book

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  • fda
  • EDQM
  • WHO-GMP

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RLD : No

TE Code : AB1

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 20MG

Approval Date : 2011-12-01

Application Number : 78458

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

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  • EDQM
  • WHO-GMP

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RLD : No

TE Code : AB1

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 30MG

Approval Date : 2011-12-01

Application Number : 78458

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

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  • EDQM
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RLD : No

TE Code : AB1

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 40MG

Approval Date : 2011-12-01

Application Number : 78458

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

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  • EDQM
  • WHO-GMP

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RLD : No

TE Code : AB1

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 60MG

Approval Date : 2016-06-23

Application Number : 78458

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

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  • WHO-GMP

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RLD : No

TE Code : AB1

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MG

Approval Date : 2018-02-26

Application Number : 200886

RX/OTC/DISCN : RX

RLD : No

TE Code : AB1

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India
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  • WHO-GMP

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RLD : No

TE Code : AB

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 18MG

Approval Date : 2020-07-29

Application Number : 213473

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DR REDDYS

India
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  • WHO-GMP

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RLD : No

TE Code : AB

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 27MG

Approval Date : 2020-07-29

Application Number : 213473

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DR REDDYS

India
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  • EDQM
  • WHO-GMP

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RLD : No

TE Code : AB

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 36MG

Approval Date : 2020-07-29

Application Number : 213473

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DR REDDYS

India
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  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

RLD : No

TE Code : AB

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 54MG

Approval Date : 2020-07-29

Application Number : 213473

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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RLD : No

TE Code :

METHYLPHENIDATE HYDROCHLORIDE

Brand Name : METHYLPHENIDATE HYDROCHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 36MG

Approval Date : 2019-07-15

Application Number : 204659

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Europe

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AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Methylphenidate hydrochloride

Brand Name : Methylphenidate Medical Valley

Dosage Form : Depot tablet

Dosage Strength : 18 mg

Packaging : Boks 30item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

Mepha Pharma AG

Switzerland
AMWC Asia-TDAC
Not Confirmed
arrow

Mepha Pharma AG

Switzerland
arrow
AMWC Asia-TDAC
Not Confirmed

Methylphenidate hydrochloride

Brand Name : Methylphenidat-Mepha

Dosage Form : Depotabs

Dosage Strength : 54mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

AMWC Asia-TDAC
Not Confirmed
arrow
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AMWC Asia-TDAC
Not Confirmed

Methylphenidate hydrochloride

Brand Name : Ritalin LA

Dosage Form : Kaps

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

Orifarm AB

Denmark
AMWC Asia-TDAC
Not Confirmed
arrow

Orifarm AB

Denmark
arrow
AMWC Asia-TDAC
Not Confirmed

methylphenidate hydrochloride

Brand Name : Concerta

Dosage Form : PROLONGED-RELEASE TABLET

Dosage Strength : 36 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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05

Orifarm AB

Denmark
AMWC Asia-TDAC
Not Confirmed
arrow

Orifarm AB

Denmark
arrow
AMWC Asia-TDAC
Not Confirmed

metylfenidathydroklorid

Brand Name : Equasym Depot

Dosage Form : KAPSEL MED MODIFIERAD FRISÄTTNING, HÅRD

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

Orifarm AB

Denmark
AMWC Asia-TDAC
Not Confirmed
arrow

Orifarm AB

Denmark
arrow
AMWC Asia-TDAC
Not Confirmed

metylfenidathydroklorid

Brand Name : Medikinet

Dosage Form : KAPSEL MED MODIFIERAD FRISÄTTNING, HÅRD

Dosage Strength : 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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07

Orifarm AB

Denmark
AMWC Asia-TDAC
Not Confirmed
arrow

Orifarm AB

Denmark
arrow
AMWC Asia-TDAC
Not Confirmed

metylfenidathydroklorid

Brand Name : Ritalina

Dosage Form : KAPSEL MED MODIFIERAD FRISÄTTNING, HÅRD

Dosage Strength : 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

Sandoz - K?benhavn

Switzerland
AMWC Asia-TDAC
Not Confirmed
arrow

Sandoz - K?benhavn

Switzerland
arrow
AMWC Asia-TDAC
Not Confirmed

Methylphenidate hydrochloride

Brand Name : Methylphenidate Sandoz

Dosage Form : Depot tablet

Dosage Strength : 18 mg

Packaging : Bottle 30item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

Omnia Läkemedel AB

Country
AMWC Asia-TDAC
Not Confirmed
arrow

Omnia Läkemedel AB

Country
arrow
AMWC Asia-TDAC
Not Confirmed

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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10

Omnia Läkemedel AB

Country
AMWC Asia-TDAC
Not Confirmed
arrow

Omnia Läkemedel AB

Country
arrow
AMWC Asia-TDAC
Not Confirmed

metylfenidathydroklorid

Brand Name : Medikinet

Dosage Form : KAPSEL MED MODIFIERAD FRISÄTTNING, HÅRD

Dosage Strength : 30 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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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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ABOUT THIS PAGE

Looking for 298-59-9 / Methylphenidate Hydrochloride API manufacturers, exporters & distributors?

Methylphenidate Hydrochloride manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylphenidate Hydrochloride manufacturer or Methylphenidate Hydrochloride supplier.

PharmaCompass also assists you with knowing the Methylphenidate Hydrochloride API Price utilized in the formulation of products. Methylphenidate Hydrochloride API Price is not always fixed or binding as the Methylphenidate Hydrochloride Price is obtained through a variety of data sources. The Methylphenidate Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Methylphenidate Hydrochloride

Synonyms

298-59-9, Centedrin, Centedrine, Methylphenidate hcl, Concerta, Ritalin

Cas Number

298-59-9

About 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.

Ritalin LA Manufacturers

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

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

Ritalin LA Suppliers

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

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

Ritalin LA USDMF

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

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

click here to find a list of Ritalin LA suppliers with USDMF on PharmaCompass.

Ritalin LA JDMF

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

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

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

click here to find a list of Ritalin LA suppliers with JDMF on PharmaCompass.

Ritalin LA KDMF

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

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

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

click here to find a list of Ritalin LA suppliers with KDMF on PharmaCompass.

Ritalin LA CEP

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

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

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

Ritalin LA WC

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

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

Ritalin LA NDC

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

Finished drug products

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

Unfinished drugs

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

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

Compounded drug products

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

click here to find a list of Ritalin LA suppliers with NDC on PharmaCompass.

Ritalin LA GMP

Ritalin LA Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

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

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

Ritalin LA CoA

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

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

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

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