Excipient Market Overview: Clariant sets up its first PEG excipients facility in US; India harmonizes 22 excipient monographs

DATA COMPILATION
#PharmaFlow

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Stock Recap
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Methylphenidate hydrochloride (JAN/USP)

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 19 USDMF, 17 CEP/COS, 2 JDMF, 4 EU WC, 9 KDMF, 20 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

45 Drugs in Development

45 Drugs in Development

FINISHED DOSAGE FORMULATIONS

588 FDF Dossiers, 262 FDA Orange Book, 200 Europe, 58 Canada, 34 South Africa, 34 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- 5MG, TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION, EXTENDED RELEASE;ORAL - 5MG/ML, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL -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- 5MG/5ML, TABLET, CHEWABLE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2 EUROAPI, 1 Minakem, 6 Evonik, 8 Rochem International Inc, 20 SPI Pharma, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 8 Kirsch Pharma, 1 Panvo Organics, 3 Dr. Paul Lohmann GmbH & Co. KGaA, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 38 BASF, 1 Bioplus Life Sciences, 3 CD Formulation, 20 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Gloria Interchem, 2 Hayashibara, 13 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Neelkanth MineChem, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 3 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, 10 Sigachi Industries, 3 Silverline Chemicals, 6 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 3 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

83 Fillers, Diluents & Binders, 79 Coating Systems & Additives, 49 Controlled & Modified Release, 48 Thickeners and Stabilizers, 40 Direct Compression, 39 Taste Masking, 35 Granulation, 33 Solubilizers, 30 Film Formers & Plasticizers, 29 Parenteral, 28 Topical, 27 Lubricants & Glidants, 26 Disintegrants & Superdisintegrants, 24 Chewable & Orodispersible Aids, 13 Co-Processed Excipients, 11 Emulsifying Agents, 9 API Stability Enhancers, 9 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 71 News #PharmaBuzz

GLOBAL SALES INFORMATION

47 US Medicaid Prescriptions, 41 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

224 US Patents, 57 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
31/03/2026	Veranova	U.S.A	VERANOVA LP	10137	METHYLPHENIDATE HYDROCHLORIDE USP	1993-03-05	Active	II	N/A
31/03/2026	Noramco	U.S.A	NORAMCO LLC	22244	METHYLPHENIDATE HYDROCHLORIDE	2008-12-19	Active	II	Complete	2013-03-27	2012-11-23

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Methylphenidate Hydrochloride (JAN/USP)

Methylphenidate hydrochloride (JAN/USP)

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

44 API Suppliers

19 USDMF

17 CEP/COS

2 JDMF

4 EU WC

9 KDMF

20 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

45 Drugs in Development

FINISHED DOSAGE FORMULATIONS

588 FDF Dossiers

262 FDA Orange Book

200 Europe

58 Canada

34 South Africa

34 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

2 EUROAPI

1 Minakem

6 Evonik

8 Rochem International Inc

20 SPI Pharma

2 Pharm-RX Chemical

1 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

8 Kirsch Pharma

1 Panvo Organics

3 Dr. Paul Lohmann GmbH & Co. KGaA

4 ACG Worldwide

12 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

38 BASF

1 Bioplus Life Sciences

3 CD Formulation

20 Corel Pharma Chem

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