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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Trianex

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ACTIVE PHARMA INGREDIENTS

84 API Suppliers, 27 USDMF, 11 CEP/COS, 5 JDMF, 10 EU WC, 21 KDMF, 29 NDC API, 1 VMF, 36 Listed Suppliers

DEVELOPMENTS

73 Drugs in Development

73 Drugs in Development

FINISHED DOSAGE FORMULATIONS

361 FDF Dossiers, 232 FDA Orange Book, 83 Europe, 17 Canada, 2 South Africa, 27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML, SPRAY;TOPICAL - 0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 40MG/ML, INJECTABLE;INJECTION - 80MG/ML, SPRAY, METERED;NASAL - 0.055MG/SPRAY, FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL, CREAM;TOPICAL - 0.025%, CREAM;TOPICAL - 0.1%, CREAM;TOPICAL - 0.5%, OINTMENT;TOPICAL - 0.025%, OINTMENT;TOPICAL - 0.1%, OINTMENT;TOPICAL - 0.5%

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 4 Rochem International Inc, 9 SPI Pharma, 1 Pharm-RX Chemical, 3 Gangwal Healthcare, 13 Nanjing Well Pharmaceutical, 12 Kirsch Pharma, 5 Dr. Paul Lohmann GmbH & Co. KGaA, 4 ACG Worldwide, 15 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 22 BASF, 3 CD Formulation, 1 Clariant, 2 DFE Pharma, 2 Esteem Industries, 6 Finar, 12 Gangwal Chemicals, 4 Gloria Interchem, 1 Ideal Cures, 1 JJ Chemicals, 2 Kerry, 2 Keval Exports, 1 Kima Chemical, 3 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 1 Pharmatrans-Sanaq, 3 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 19 Roquette, 12 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 1 Silverline Chemicals, 1 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

42 Topical, 39 Solubilizers, 37 Parenteral, 36 Thickeners and Stabilizers, 24 Fillers, Diluents & Binders, 19 Film Formers & Plasticizers, 18 Emulsifying Agents, 16 Surfactant & Foaming Agents, 12 Coating Systems & Additives, 12 Direct Compression, 11 Co-Processed Excipients, 10 Controlled & Modified Release, 9 Taste Masking, 8 API Stability Enhancers, 8 Granulation, 8 Empty Capsules, 7 Chewable & Orodispersible Aids, 6 Rheology Modifiers, 5 Disintegrants & Superdisintegrants, 4 Lubricants & Glidants, 1 Soft Gelatin

DIGITAL CONTENT

111 News #PharmaBuzz

111 News #PharmaBuzz

GLOBAL SALES INFORMATION

53 US Medicaid Prescriptions, 32 Regulatory FDF Prices

MARKET PLACE

31 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 JP

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
Coral Drugs Private Limited	sales@coraldrugs.com	https://www.pharmacompass.com/pharma-services/api-manufacturing-services/coral-drugs-private-limited	India	CORAL DRUGS PRIVATE LTD	31357	TRIAMCINOLONE ACETONIDE	2017-02-06	Active	II	Complete	2019-11-14	2019-07-23
Axplora	axplora@axplora.com	https://www.pharmacompass.com/pharma-services/api-fdf-drug-development/axplora-farmabios-pharmazell-and-novasep	Germany	FARMABIOS SPA	14693	TRIAMCINOLONE ACETONIDE	2000-02-01	Active	II	Complete	2013-05-21	2013-05-14

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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.

Trianex

Trianex

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

84 API Suppliers

27 USDMF

11 CEP/COS

5 JDMF

10 EU WC

21 KDMF

29 NDC API

1 VMF

36 Listed Suppliers

DEVELOPMENTS

73 Drugs in Development

FINISHED DOSAGE FORMULATIONS

361 FDF Dossiers

232 FDA Orange Book

83 Europe

17 Canada

2 South Africa

27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 10MG/ML

SPRAY;TOPICAL - 0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 40MG/ML

INJECTABLE;INJECTION - 80MG/ML

SPRAY, METERED;NASAL - 0.055MG/SPRAY

FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL

CREAM;TOPICAL - 0.025%

CREAM;TOPICAL - 0.1%

CREAM;TOPICAL - 0.5%

OINTMENT;TOPICAL - 0.025%

OINTMENT;TOPICAL - 0.1%

OINTMENT;TOPICAL - 0.5%

RELATED EXCIPIENT COMPANIES

2 EUROAPI

4 Rochem International Inc

9 SPI Pharma

1 Pharm-RX Chemical

3 Gangwal Healthcare

13 Nanjing Well Pharmaceutical

12 Kirsch Pharma

5 Dr. Paul Lohmann GmbH & Co. KGaA

4 ACG Worldwide

15 Actylis

2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

22 BASF

3 CD Formulation

1 Clariant

2 DFE Pharma

2 Esteem Industries

6 Finar

12 Gangwal Chemicals

4 Gloria Interchem

1 Ideal Cures

1 JJ Chemicals

2 Kerry

2 Keval Exports

1 Kima Chemical

3 Lonza Capsugel

11 Microlex e.U

1 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

1 Pharmatrans-Sanaq

3 Pluviaendo

1 Prachin Chemical

1 Qualicaps

19 Roquette

12 Seppic

1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

8 Sigachi Industries

1 Silverline Chemicals

CREAM;TOPICAL - 0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CREAM;TOPICAL - 0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY;TOPICAL - 0.147MG/GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons