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

DATA COMPILATION
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Pipeline Prospector March 2026 highlights: Lilly to acquire Centessa for US$ 7.8 bn; Merck buys Terns Pharma for US$ 6.7 bn

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 6 USDMF, 5 CEP/COS, 9 EU WC, 1 KDMF, 5 NDC API, 30 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

9 Intermediate Suppliers

9 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers, 32 FDA Orange Book, 169 Europe, 8 Canada, 5 Australia, 5 South Africa, 49 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE, SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 2 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 19 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 1 Ingredion Pharma Solutions, 21 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 25 Controlled & Modified Release, 21 Granulation, 18 Thickeners and Stabilizers, 17 Direct Compression, 15 Disintegrants & Superdisintegrants, 13 Solubilizers, 12 Topical, 11 Lubricants & Glidants, 9 Film Formers & Plasticizers, 9 Co-Processed Excipients, 7 Taste Masking, 6 Parenteral, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Coloring Agents

DIGITAL CONTENT

39 News #PharmaBuzz

39 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 16 Regulatory FDF Prices

MARKET PLACE

26 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

25 US Patents, 8 US Exclusivities, 67 Health Canada Patents

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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	Noramco	U.S.A	NORAMCO LLC	21084	TAPENTADOL HYDROCHLORIDE (R331333) DRUG SUBSTANCE	2008-01-23	Active	II	Complete	2020-08-05	2020-07-30
31/03/2026	Curia	U.S.A	CURIA MISSOURI INC	26490	TAPENTADOL HYDROCHLORIDE DRUG SUBSTANCE	2012-09-27	Active	II	Complete	2013-03-13	2012-11-02

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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.

Nucynta

Nucynta

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

43 API Suppliers

6 USDMF

5 CEP/COS

9 EU WC

1 KDMF

5 NDC API

30 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

INTERMEDIATES

9 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

268 FDF Dossiers

32 FDA Orange Book

169 Europe

8 Canada

5 Australia

5 South Africa

49 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 100MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 150MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 200MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 250MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 50MG BASE

SOLUTION;ORAL - EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 100MG BASE

TABLET;ORAL - EQ 50MG BASE

TABLET;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

1 SPI Pharma

1 Pharm-RX Chemical

1 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Kirsch Pharma

2 Dr. Paul Lohmann GmbH & Co. KGaA

1 ACG Worldwide

3 Actylis

1 Aeon Procare

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

19 BASF

1 Bioplus Life Sciences

1 CD Formulation

10 Corel Pharma Chem

5 DFE Pharma

1 Esteem Industries

2 Finar

7 Gangwal Chemicals

5 Ideal Cures

1 Ingredion Pharma Solutions

21 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

1 Neelkanth MineChem

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

10 Roquette

7 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

3 Silverline Chemicals

2 The Dow Chemical Company

SOLUTION;ORAL - EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons