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Methylphenidate Hydrochloride

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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, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

FINISHED DOSAGE FORMULATIONS

613 FDF Dossiers, 262 FDA Orange Book, 232 Europe, 52 Canada, 30 South Africa, 37 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- 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL -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- 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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, 7 Faran Shimi Pharmaceutical, 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, 7 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, 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, 45 Direct Compression, 37 Taste Masking, 31 Solubilizers, 30 Granulation, 30 Film Formers & Plasticizers, 27 Topical, 27 Parenteral, 27 Lubricants & Glidants, 27 Disintegrants & Superdisintegrants, 22 Chewable & Orodispersible Aids, 19 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

6 DATA COMPILATION #PharmaFlow, 70 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 150 Finished Drug Prices, 2 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

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

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 3 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Veranova	U.S.A	VERANOVA LP	10137	METHYLPHENIDATE HYDROCHLORIDE USP	1993-03-05	Active	II	N/A
28/10/2024	Noramco	U.S.A	NORAMCO LLC	22244	METHYLPHENIDATE HYDROCHLORIDE	2008-12-19	Active	II	Complete	2013-03-27	2012-11-23

Methylphenidate Hydrochloride

Methylphenidate Hydrochloride

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

36 API Suppliers

20 USDMF

16 CEP/COS

1 JDMF

6 EU WC

8 KDMF

22 NDC API

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

13 Drugs in Development

FINISHED DOSAGE FORMULATIONS

613 FDF Dossiers

262 FDA Orange Book

232 Europe

52 Canada

30 South Africa

37 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**

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

7 Faran Shimi Pharmaceutical

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

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

38 BASF

1 Bioplus Life Sciences

20 Corel Pharma Chem

6 DFE Pharma

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

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