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

83 API Suppliers, 28 USDMF, 14 CEP/COS, 6 JDMF, 11 EU WC, 10 KDMF, 39 NDC API, 1 VMF, 32 Listed Suppliers

DEVELOPMENTS

53 Drugs in Development

53 Drugs in Development

FINISHED DOSAGE FORMULATIONS

597 FDF Dossiers, 240 FDA Orange Book, 285 Europe, 14 Canada, 8 Australia, 28 South Africa, 22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%, CREAM;TOPICAL - 5%;1%, OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, LOTION;TOPICAL - 2%, TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 8 SPI Pharma, 1 Pharm-RX Chemical, 5 Gangwal Healthcare, 24 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 4 Pfanstiehl, 23 Kirsch Pharma, 9 Dr. Paul Lohmann GmbH & Co. KGaA, 22 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 42 BASF, 3 BioSpectra, 4 CD Formulation, 1 Clariant, 15 Corel Pharma Chem, 7 DFE Pharma, 3 Esteem Industries, 6 Finar, 16 Gangwal Chemicals, 4 Gloria Interchem, 2 Hayashibara, 2 Ideal Cures, 4 Ingredion Pharma Solutions, 19 Kerry, 3 Keval Exports, 9 Lubrizol Life Science Health, 17 Microlex e.U, 3 Nanjing Bold Chemical, 2 Neelkanth MineChem, 2 Nippon Fine Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 33 Roquette, 21 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 5 Silverline Chemicals, 1 Symrise, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

84 Topical, 61 Thickeners and Stabilizers, 59 Solubilizers, 55 Parenteral, 51 Fillers, Diluents & Binders, 36 Direct Compression, 34 Emulsifying Agents, 33 Granulation, 25 Coating Systems & Additives, 25 Disintegrants & Superdisintegrants, 24 Surfactant & Foaming Agents, 24 Lubricants & Glidants, 23 Controlled & Modified Release, 20 Film Formers & Plasticizers, 18 Taste Masking, 15 Co-Processed Excipients, 14 API Stability Enhancers, 12 Chewable & Orodispersible Aids, 7 Rheology Modifiers, 1 Soft Gelatin

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 54 News #PharmaBuzz

GLOBAL SALES INFORMATION

38 US Medicaid Prescriptions, 54 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

39 APIs, 17 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents, 1 US Exclusivities, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 JP, 27 Others

ANALYTICAL

2 BioAnalytical Methods, 4 Analytical Methods

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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	Curia	U.S.A	CURIA SPAIN SAU	33002	HYDROCORTISONE MICRONIZED	2018-07-31	Active	II	Complete	2019-01-07	2018-09-18
31/03/2026	Symbiotec Pharmalab	India	SYMBIOTEC PHARMALAB PRIVATE LTD	29221	HYDROCORTISONE HEMISUCCINATE USP	2015-03-30	Active	II	Complete	2016-02-09	2015-06-09

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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

83 API Suppliers

28 USDMF

14 CEP/COS

6 JDMF

11 EU WC

10 KDMF

39 NDC API

1 VMF

32 Listed Suppliers

DEVELOPMENTS

53 Drugs in Development

FINISHED DOSAGE FORMULATIONS

597 FDF Dossiers

240 FDA Orange Book

285 Europe

14 Canada

8 Australia

28 South Africa

22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

CREAM;TOPICAL - 5%;1%

OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 1%

LOTION;TOPICAL - 2%

TABLET;ORAL - 10MG

TABLET;ORAL - 20MG

TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 Rochem International Inc

8 SPI Pharma

1 Pharm-RX Chemical

5 Gangwal Healthcare

24 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

4 Pfanstiehl

23 Kirsch Pharma

9 Dr. Paul Lohmann GmbH & Co. KGaA

22 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

42 BASF

3 BioSpectra

4 CD Formulation

1 Clariant

15 Corel Pharma Chem

7 DFE Pharma

3 Esteem Industries

6 Finar

16 Gangwal Chemicals

4 Gloria Interchem

2 Hayashibara

2 Ideal Cures

4 Ingredion Pharma Solutions

19 Kerry

3 Keval Exports

9 Lubrizol Life Science Health

17 Microlex e.U

3 Nanjing Bold Chemical

2 Neelkanth MineChem

2 Nippon Fine Chemical

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

33 Roquette

21 Seppic

2 Shandong Focus Biotechnology Co., Ltd

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons