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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ACTIVE PHARMA INGREDIENTS

46 API Suppliers, 22 USDMF, 17 CEP/COS, 7 JDMF, 3 EU WC, 8 KDMF, 15 NDC API, 18 Listed Suppliers

DEVELOPMENTS

57 Drugs in Development

57 Drugs in Development

FINISHED DOSAGE FORMULATIONS

790 FDF Dossiers, 162 FDA Orange Book, 481 Europe, 26 Canada, 72 Australia, 12 South Africa, 37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG, TABLET;ORAL - 25MG;100MG, TABLET;ORAL - 25MG;250MG, TABLET;ORAL - 25MG, TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG, CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG, CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG, CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG, TABLET;ORAL - 12.5MG;200MG;50MG, TABLET;ORAL - 18.75MG;200MG;75MG, TABLET;ORAL - 25MG;200MG;100MG, TABLET;ORAL - 31.25MG;200MG;125MG, TABLET;ORAL - 37.5MG;200MG;150MG, TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 4 Evonik, 4 Rochem International Inc, 21 SPI Pharma, 8 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 1 Capital Farma, 3 Kirsch Pharma, 1 Panvo Organics, 2 Cerata Pharmaceuticals LLP, 2 Dr. Paul Lohmann GmbH & Co. KGaA, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 29 BASF, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 2 Gloria Interchem, 9 Ideal Cures, 5 Ingredion Pharma Solutions, 22 Kerry, 4 Keval Exports, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 Neelkanth MineChem, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 57 Coating Systems & Additives, 45 Disintegrants & Superdisintegrants, 37 Direct Compression, 35 Solubilizers, 34 Granulation, 33 Controlled & Modified Release, 32 Thickeners and Stabilizers, 26 Taste Masking, 23 Chewable & Orodispersible Aids, 23 Parenteral, 22 Lubricants & Glidants, 22 Film Formers & Plasticizers, 16 Co-Processed Excipients, 15 Topical, 9 API Stability Enhancers, 8 Emulsifying Agents, 6 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 81 News #PharmaBuzz

GLOBAL SALES INFORMATION

44 US Medicaid Prescriptions, 69 Regulatory FDF Prices, 16 Annual Reports

MARKET PLACE

13 APIs, 9 FDF Dossiers

PATENTS & EXCLUSIVITIES

309 US Patents, 4 US Exclusivities, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 1 JP, 9 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
06/10/2025	TAPI Technology & API Services	Israel	M/s Teva API India Private Limited	WC-0002	Carbidopa USP/Ph.Eur/IH	2025-04-24	2028-05-25	Plot No. A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Bijnor Road, Gajraula -244235, District -Amroha, Uttar Pradesh, India
13/04/2026	Maithri Drugs	India	M/s Maithri Drugs Private Limited	WC-0407	Carbidopa USP	2024-02-12	2027-02-11	Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Mandal), Sangareddy -502313, Telangana State, India

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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

46 API Suppliers

22 USDMF

17 CEP/COS

7 JDMF

3 EU WC

8 KDMF

15 NDC API

18 Listed Suppliers

DEVELOPMENTS

57 Drugs in Development

FINISHED DOSAGE FORMULATIONS

790 FDF Dossiers

162 FDA Orange Book

481 Europe

26 Canada

72 Australia

12 South Africa

37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG

TABLET;ORAL - 25MG;100MG

TABLET;ORAL - 25MG;250MG

TABLET;ORAL - 25MG

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG

CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG

CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG

CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

TABLET;ORAL - 12.5MG;200MG;50MG

TABLET;ORAL - 18.75MG;200MG;75MG

TABLET;ORAL - 25MG;200MG;100MG

TABLET;ORAL - 31.25MG;200MG;125MG

TABLET;ORAL - 37.5MG;200MG;150MG

TABLET;ORAL - 50MG;200MG;200MG

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Minakem

4 Evonik

4 Rochem International Inc

21 SPI Pharma

8 Boai NKY Pharmaceuticals Ltd

7 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

1 Capital Farma

3 Kirsch Pharma

1 Panvo Organics

2 Cerata Pharmaceuticals LLP

2 Dr. Paul Lohmann GmbH & Co. KGaA

1 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

29 BASF

12 Corel Pharma Chem

6 DFE Pharma

1 Esteem Industries

1 Finar

12 Gangwal Chemicals

2 Gloria Interchem

9 Ideal Cures

5 Ingredion Pharma Solutions

22 Kerry

4 Keval Exports

5 Kima Chemical

6 Lonza Capsugel

17 Microlex e.U

1 Nanjing Bold Chemical

1 Neelkanth MineChem

3 Nitika Pharmaceutical Specialities

TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons