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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Epitec

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ACTIVE PHARMA INGREDIENTS

79 API Suppliers, 33 USDMF, 20 CEP/COS, 6 JDMF, 21 EU WC, 10 KDMF, 19 NDC API, 43 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

36 Drugs in Development

36 Drugs in Development

INTERMEDIATES

16 Intermediate Suppliers

16 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1293 FDF Dossiers, 243 FDA Orange Book, 797 Europe, 32 Canada, 66 Australia, 80 South Africa, 75 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG, TABLET;ORAL - 150MG, TABLET;ORAL - 200MG, TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 10 Evonik, 5 Rochem International Inc, 23 SPI Pharma, 1 Pharm-RX Chemical, 10 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 Kirsch Pharma, 1 Panvo Organics, 2 Cerata Pharmaceuticals LLP, 13 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 8 Actylis, 3 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 38 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 1 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 4 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 13 Gangwal Chemicals, 2 Gloria Interchem, 1 Huzhou Sunflower Pharmaceutical, 10 Ideal Cures, 5 Ingredion Pharma Solutions, 2 JJ Chemicals, 27 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 2 Neelkanth MineChem, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 14 Seppic, 9 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

95 Fillers, Diluents & Binders, 81 Coating Systems & Additives, 52 Direct Compression, 49 Disintegrants & Superdisintegrants, 44 Taste Masking, 40 Controlled & Modified Release, 39 Granulation, 35 Solubilizers, 28 Thickeners and Stabilizers, 28 Lubricants & Glidants, 24 Chewable & Orodispersible Aids, 24 Film Formers & Plasticizers, 20 Parenteral, 18 Co-Processed Excipients, 17 Topical, 9 API Stability Enhancers, 8 Emulsifying Agents, 6 Surfactant & Foaming Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

46 News #PharmaBuzz

46 News #PharmaBuzz

GLOBAL SALES INFORMATION

43 US Medicaid Prescriptions, 102 Regulatory FDF Prices, 11 Annual Reports

MARKET PLACE

11 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents, 6 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 12 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ 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	IOL Chemicals and Pharmaceuticals	India	IOL CHEMICALS AND PHARMACEUTICALS LTD	26627	LAMOTRIGINE	2012-11-15	Active	II	N/A
31/03/2026	Cohance Lifesciences	India	COHANCE LIFESCIENCES LTD	23251	LAMOTRIGINE USP	2009-11-04	Active	II	Complete	2013-08-29	2013-03-20

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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.

Epitec

Epitec

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

79 API Suppliers

33 USDMF

20 CEP/COS

6 JDMF

21 EU WC

10 KDMF

19 NDC API

43 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

36 Drugs in Development

INTERMEDIATES

16 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1293 FDF Dossiers

243 FDA Orange Book

797 Europe

32 Canada

66 Australia

80 South Africa

75 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG

TABLET;ORAL - 150MG

TABLET;ORAL - 200MG

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 25MG

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

10 Evonik

5 Rochem International Inc

23 SPI Pharma

1 Pharm-RX Chemical

10 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

4 Kirsch Pharma

1 Panvo Organics

2 Cerata Pharmaceuticals LLP

13 Dr. Paul Lohmann GmbH & Co. KGaA

1 ACG Worldwide

8 Actylis

3 Aeon Procare

3 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

38 BASF

1 Bioplus Life Sciences

1 CD Formulation

1 Clariant

16 Corel Pharma Chem

7 DFE Pharma

4 Doshion Polyscience

1 Esteem Industries

1 Finar

13 Gangwal Chemicals

2 Gloria Interchem

1 Huzhou Sunflower Pharmaceutical

10 Ideal Cures

5 Ingredion Pharma Solutions

2 JJ Chemicals

27 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

20 Microlex e.U

1 Nanjing Bold Chemical

2 Neelkanth MineChem

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

5 Novo Excipients

TABLET;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons