CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

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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Daonil

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 15 USDMF, 9 CEP/COS, 4 JDMF, 8 EU WC, 1 KDMF, 7 NDC API, 17 Listed Suppliers

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

INTERMEDIATES

9 Intermediate Suppliers

9 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

187 FDF Dossiers, 83 FDA Orange Book, 31 Europe, 7 Canada, 2 Australia, 19 South Africa, 45 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1.25MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 5MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 7 SPI Pharma, 8 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Kirsch Pharma, 1 Cerata Pharmaceuticals LLP, 11 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 Avesta Pharma, 27 BASF, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 2 Finar, 11 Gangwal Chemicals, 1 Gloria Interchem, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 2 JJ Chemicals, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

74 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 37 Direct Compression, 31 Granulation, 31 Controlled & Modified Release, 30 Solubilizers, 25 Disintegrants & Superdisintegrants, 25 Thickeners and Stabilizers, 19 Film Formers & Plasticizers, 19 Topical, 18 Lubricants & Glidants, 15 Co-Processed Excipients, 13 Parenteral, 11 Taste Masking, 10 Chewable & Orodispersible Aids, 9 Emulsifying Agents, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

26 News #PharmaBuzz

26 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 21 Regulatory FDF Prices

MARKET PLACE

15 APIs, 5 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 6 Others

Xls

Filters

Supplier	Contact Email	Supplier's Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
Aurobindo Pharma Limited	enquiries@pharmacompass.com	https://www.pharmacompass.com/api-manufacturers/aurobindo-pharma-limited	India	APITORIA PHARMA PRIVATE LTD	17152	GLYBURIDE USP	2004-01-20	Active	II	N/A
Cadila Pharmaceuticals	enquiries@pharmacompass.com	https://www.pharmacompass.com/api-manufacturers/cadila-pharmaceuticals	India	CADILA PHARMACEUTICALS LTD	17093	GLYBURIDE USP	2004-01-14	Active	II	Complete	2013-10-05	2013-09-26

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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.

Daonil

Daonil

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

32 API Suppliers

15 USDMF

9 CEP/COS

4 JDMF

8 EU WC

1 KDMF

7 NDC API

17 Listed Suppliers

DEVELOPMENTS

13 Drugs in Development

INTERMEDIATES

9 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

187 FDF Dossiers

83 FDA Orange Book

31 Europe

7 Canada

2 Australia

19 South Africa

45 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1.25MG

TABLET;ORAL - 2.5MG

TABLET;ORAL - 5MG

TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik

7 SPI Pharma

8 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Kirsch Pharma

1 Cerata Pharmaceuticals LLP

11 Dr. Paul Lohmann GmbH & Co. KGaA

1 ACG Worldwide

5 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

1 Avesta Pharma

27 BASF

2 Clariant

14 Corel Pharma Chem

7 DFE Pharma

1 Esteem Industries

2 Finar

11 Gangwal Chemicals

1 Gloria Interchem

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

4 Ingredion Pharma Solutions

2 JJ Chemicals

24 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Neelkanth MineChem

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

TABLET;ORAL - 1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons