Data views / Active CEP holders (EDQM)

Suppliers holding a valid EDQM CEP

579 records Updated 9 July 2026

579 suppliers in this directory hold a valid Certificate of Suitability to the European Pharmacopoeia. The list is ranked by CEP count, with US DMF holdings shown alongside.

Top 100 of 579

SupplierValid CEPsUS DMFsLatest FDA inspectionCountry
Cipla 272161VAI 2025India
Apitoria Pharma 173303VAI 2025India
Ipca Laboratories 13252VAI 2025India
Alembic Pharmaceuticals 124145VAI 2025India
MSN Laboratories 121517NAI 2026India
Dr Reddy's Laboratories 90279NAI 2025India
Micro Labs 8455VAI 2025India
Olon 80167NAI 2025Italy
Zhejiang Huahai Pharmaceutical 6886OAI 2025China
Hetero 67380VAI 2025India
EUROAPI 5348VAI 2022France
Macleods Pharmaceuticals 52129VAI 2024India
Zydus Lifesciences 52150VAI 2025India
MSN Life Sciences 48160VAI 2024India
Alivus Life Sciences 43272NAI 2025India
Granules India 4295VAI 2025India
Siegfried 4094VAI 2025Germany
Krka 37——Slovenia
Lupin 37135VAI 2025India
Moehs 3449VAI 2023Spain
Ajinomoto 3334VAI 2025Japan
Cohance Lifesciences 33108NAI 2025India
Nosch Labs 32—VAI 2024India
Solara Active Pharma Sciences 3291VAI 2026India
Industriale Chimica 3140VAI 2022Italy
Neuland Laboratories 31148VAI 2025India
“Gedeon Richter” 3015—Hungary
Bayer 29—VAI 2024Finland
Biocon 2969VAI 2025India
Harman Finochem 2931NAI 2025India
Piramal Pharma 2962VAI 2025India
Unichem Laboratories 29—VAI 2026India
Laurus Labs 28118VAI 2025India
Aurore Life Sciences 2735VAI 2024India
Shilpa Pharma Lifesciences 2753NAI 2025India
Divi's Laboratories 2631NAI 2025India
Life Technologies 24——United States
Maithri Drugs 24106VAI 2025India
Excella Gmbh 2326VAI 2022Germany
Fermion 2332VAI 2023Finland
Janssen Pharmaceutica 23——Belgium
Metrochem API 23——India
Sterling Pharma Solutions 2332VAI 2025Malta
Amino Chemicals 2225VAI 2024Germany
Hisun Pharmaceutical 22——China
SMS Pharmaceuticals 2241OAI 2025India
Arevipharma 217VAI 2025Germany
CTX Lifesciences 2127VAI 2022India
IOL Chemicals and Pharmaceuticals 2116VAI 2019India
Macfarlan Smith 205VAI 2021United Kingdom
Newchem 2019VAI 2023Italy
Sandoz 2040VAI 2024Switzerland
Symed Labs 2060VAI 2025India
Centaur Pharmaceuticals 1937VAI 2025India
Frey Lau 19——Germany
Hikal 1932OAI 2025India
Indena 1912VAI 2021Italy
Sterling 1924VAI 2022Italy
Synthimed Labs 1940NAI 2020India
Acs Dobfar 18160VAI 2023Italy
Cadila Pharmaceuticals 1832NAI 2025India
Cambrex Profarmaco Milano 1894NAI 2022Italy
Shouguang Fukang Pharmaceutical 1811VAI 2025China
Erregierre 1724NAI 2025Italy
Sanofi Winthrop Industrie 17—VAI 2024France
Zhejiang Tianyu Pharmaceutical 1712VAI 2024China
Ami Lifesciences 1639VAI 2024India
Dipharma Francis 1636VAI 2022Italy
FDC Limited 1615NAI 2023India
Kyowa Hakko Bio 162NAI 2024Japan
Lee Pharma 1654NAI 2025India
Specgx 1656VAI 2025United States
TAPI Czech Industries s.r.o 16——Czech Republic
Orchid Pharma 1545VAI 2025India
Zhejiang Guobang 1516VAI 2025China
BASF 1417VAI 2025Germany
Livzon Group Fuzhou Fuxing Pharmaceutical 1415NAI 2024China
Morepen Laboratories 1431NAI 2023India
Shandong Anhong Pharmaceutical 1426VAI 2019China
Shanghai Plumino Amino Acid 141VAI 2023China
Siegfried Evionnaz 1426VAI 2023Switzerland
USV 1430VAI 2025India
Concord Biotech 1322VAI 2025India
Mankind Pharma 1364VAI 2025India
Melody Healthcare 1312VAI 2025India
Merck KGaA 12——Germany
Natco Pharma 12102VAI 2025India
PharmaZell 129VAI 2025Germany
Qilu Pharmaceutical 1231NAI 2025China
Shandong Anxin Pharmaceutical 1219VAI 2019China
Shaoxing Jingxin Pharmaceutical 127NAI 2024China
Synthon 1216—Netherlands
Vamsi Labs 1214VAI 2018India
Wuhan Wuyao Pharmaceutical 12—VAI 2025China
Alivira Animal Health 112VAI 2023India
Gelita 11—VAI 2023Germany
Leo Pharma 112VAI 2024Denmark
Medilux Laboratories 1110VAI 2024India
MSN Organics 1132VAI 2023India
Ningbo Menovo Pharmaceutical 111—China

Showing the top 100 of 579. Every row links to its full profile; the complete set is on the supplier index.

Where these figures come from

Every number on this page is counted from published registers — nothing is modelled or estimated. Records last refreshed 9 July 2026. How we count our figures.

Source
EDQM certificate database
Source
FDA, List of Drug Master Files
Source
FDA inspection classifications

Questions

What is a CEP?
A Certificate of Suitability, issued by the EDQM, confirms that a supplier's active ingredient is adequately controlled by the relevant European Pharmacopoeia monograph. It is the European counterpart to referencing a US drug master file.
How many suppliers hold a valid CEP?
579 of the 3182 suppliers profiled here hold at least one valid CEP.
Is a CEP the same as an EU GMP certificate?
No. A CEP covers the quality of the substance against a monograph; a GMP certificate covers the manufacturing site. A supplier can hold one without the other.

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