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

DATA COMPILATION
#PharmaFlow

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

Stock Recap
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ACTIVE PHARMA INGREDIENTS

242 API Suppliers, 80 USDMF, 20 CEP/COS, 17 JDMF, 9 EU WC, 109 KDMF, 105 NDC API, 32 Listed Suppliers

DEVELOPMENTS

185 Drugs in Development

185 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3584 FDF Dossiers, 737 FDA Orange Book, 1305 Europe, 309 Canada, 105 Australia, 424 South Africa, 704 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG, SUPPOSITORY;RECTAL - 325MG, SUPPOSITORY;RECTAL - 650MG, SUPPOSITORY;RECTAL - 80MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG;15MG, TABLET;ORAL - 300MG;30MG, TABLET;ORAL - 300MG;60MG, TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;50MG;40MG, TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Minakem, 1 Evonik, 13 Rochem International Inc, 32 SPI Pharma, 2 Pharm-RX Chemical, 14 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 21 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 14 Kirsch Pharma, 1 Panvo Organics, 2 Cerata Pharmaceuticals LLP, 24 Dr. Paul Lohmann GmbH & Co. KGaA, 4 ACG Worldwide, 19 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 Ashland, 1 Avesta Pharma, 44 BASF, 8 Beneo, 2 Bioplus Life Sciences, 6 CD Formulation, 6 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 4 Finar, 17 Gangwal Chemicals, 4 Gloria Interchem, 2 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 2 JJ Chemicals, 26 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 27 Microlex e.U, 2 Nanjing Bold Chemical, 5 Neelkanth MineChem, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 56 Roquette, 22 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

124 Fillers, Diluents & Binders, 75 Thickeners and Stabilizers, 72 Solubilizers, 69 Coating Systems & Additives, 58 Taste Masking, 55 Direct Compression, 55 Topical, 54 Parenteral, 49 Disintegrants & Superdisintegrants, 45 Granulation, 44 Lubricants & Glidants, 38 Film Formers & Plasticizers, 35 Controlled & Modified Release, 30 Emulsifying Agents, 28 Chewable & Orodispersible Aids, 23 API Stability Enhancers, 19 Co-Processed Excipients, 17 Surfactant & Foaming Agents, 10 Rheology Modifiers, 9 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 378 News #PharmaBuzz

GLOBAL SALES INFORMATION

94 US Medicaid Prescriptions, 66 Regulatory FDF Prices, 21 Annual Reports

MARKET PLACE

199 APIs, 95 FDF Dossiers

PATENTS & EXCLUSIVITIES

41 US Patents, 2 US Exclusivities, 7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 JP, 36 Others

ANALYTICAL

2 BioAnalytical Methods, 8 Analytical Methods

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
Granules India Limited	sales@granulesindia.com	https://www.pharmacompass.com/api-manufacturers/granules-india-limited	India	GRANULES INDIA LTD	17722	COMPRESSO PAP 90 CPF	2004-09-22	Active	II	N/A
IOL Chemicals and Pharmaceuticals	contact@iolcp.com	https://www.pharmacompass.com/api-manufacturers/iol-chemicals-and-pharmaceuticals	India	IOL CHEMICALS AND PHARMACEUTICALS LTD	37336	ACETAMINOPHEN USP (PARACETAMOL USP)	2022-07-28	Active	II	Complete	2025-02-28	2025-01-23

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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.

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

242 API Suppliers

80 USDMF

20 CEP/COS

17 JDMF

9 EU WC

109 KDMF

105 NDC API

32 Listed Suppliers

DEVELOPMENTS

185 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

3584 FDF Dossiers

737 FDA Orange Book

1305 Europe

309 Canada

105 Australia

424 South Africa

704 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUPPOSITORY;RECTAL - 120MG

SUPPOSITORY;RECTAL - 325MG

SUPPOSITORY;RECTAL - 650MG

SUPPOSITORY;RECTAL - 80MG

CAPSULE;ORAL - 325MG;50MG;40MG;30MG

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 250MG;250MG;65MG

TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 300MG;15MG

TABLET;ORAL - 300MG;30MG

TABLET;ORAL - 300MG;60MG

TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 325MG;50MG;40MG

TABLET;ORAL - 300MG;60MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

2 Minakem

1 Evonik

13 Rochem International Inc

32 SPI Pharma

2 Pharm-RX Chemical

14 Boai NKY Pharmaceuticals Ltd

10 Gangwal Healthcare

21 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

14 Kirsch Pharma

1 Panvo Organics

2 Cerata Pharmaceuticals LLP

24 Dr. Paul Lohmann GmbH & Co. KGaA

4 ACG Worldwide

19 Actylis

3 Aeon Procare

2 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

4 Ashland

1 Avesta Pharma

44 BASF

8 Beneo

2 Bioplus Life Sciences

6 CD Formulation

6 Clariant

12 Corel Pharma Chem

7 DFE Pharma

2 Esteem Industries

4 Finar

17 Gangwal Chemicals

4 Gloria Interchem

2 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

5 Ingredion Pharma Solutions

TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 325MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION;INTRAVENOUS - 1GM/100ML (10MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 325MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons