Data views / Suppliers holding both a US DMF and a CEP

Suppliers accredited with both FDA and EDQM

392 records Updated 9 July 2026

392 suppliers hold both an active US Type II DMF and a valid EDQM CEP. If you need one source qualified for both the US and the EU, this is the population to start from.

Top 100 of 392

SupplierUS DMFsCEPsLatest FDA inspectionCountry
MSN Laboratories 517121NAI 2026India
Apitoria Pharma 303173VAI 2025India
Hetero 38067VAI 2025India
Cipla 161272VAI 2025India
Dr Reddy's Laboratories 27990NAI 2025India
Alivus Life Sciences 27243NAI 2025India
Alembic Pharmaceuticals 145124VAI 2025India
Olon 16780NAI 2025Italy
MSN Life Sciences 16048VAI 2024India
Zydus Lifesciences 15052VAI 2025India
Ipca Laboratories 52132VAI 2025India
Macleods Pharmaceuticals 12952VAI 2024India
Neuland Laboratories 14831VAI 2025India
Acs Dobfar 16018VAI 2023Italy
Lupin 13537VAI 2025India
Zhejiang Huahai Pharmaceutical 8668OAI 2025China
Laurus Labs 11828VAI 2025India
Cohance Lifesciences 10833NAI 2025India
Micro Labs 5584VAI 2025India
Granules India 9542VAI 2025India
Siegfried 9440VAI 2025Germany
Maithri Drugs 10624VAI 2025India
Curia 1168OAI 2026Spain
Solara Active Pharma Sciences 9132VAI 2026India
Natco Pharma 10212VAI 2025India
Cambrex Profarmaco Milano 9418NAI 2022Italy
EUROAPI 4853VAI 2022France
Biocon 6929VAI 2025India
Piramal Pharma 6229VAI 2025India
Honour Lab 799VAI 2019India
Moehs 4934VAI 2023Spain
Shilpa Pharma Lifesciences 5327NAI 2025India
Symed Labs 6020VAI 2025India
Apotex 699NAI 2025Canada
Gland Pharma 753VAI 2024India
Mankind Pharma 6413VAI 2025India
Specgx 5616VAI 2025United States
Industriale Chimica 4031VAI 2022Italy
Lee Pharma 5416NAI 2025India
Ajinomoto 3433VAI 2025Japan
SMS Pharmaceuticals 4122OAI 2025India
Aurore Life Sciences 3527VAI 2024India
Emnar Pharma 566VAI 2025India
Harman Finochem 3129NAI 2025India
Orchid Pharma 4515VAI 2025India
Sandoz 4020VAI 2024Switzerland
Formosa Laboratories 518VAI 2024Taiwan
Synthimed Labs 4019NAI 2020India
Divi's Laboratories 3126NAI 2025India
Centaur Pharmaceuticals 3719VAI 2025India
Ami Lifesciences 3916VAI 2024India
Fermion 3223VAI 2023Finland
Sterling Pharma Solutions 3223VAI 2025Malta
Maithri Laboratories 467VAI 2025India
Dipharma Francis 3616VAI 2022Italy
Hikal 3219OAI 2025India
Cadila Pharmaceuticals 3218NAI 2025India
Excella Gmbh 2623VAI 2022Germany
CTX Lifesciences 2721VAI 2022India
Torrent Pharmaceuticals 399NAI 2026India
Amino Chemicals 2522VAI 2024Germany
HEC Pharm 434NAI 2024China
“Gedeon Richter” 1530—Hungary
Morepen Laboratories 3114NAI 2023India
BrightGene Bio-Medical 413VAI 2024China
USV 3014VAI 2025India
MSN Organics 3211VAI 2023India
Qilu Pharmaceutical 3112NAI 2025China
Sterling 2419VAI 2022Italy
Shandong New Time Pharmaceutical 348VAI 2024China
Shanghai Desano Chemical Pharmaceutical 3210VAI 2023China
Alkem Laboratories 374VAI 2024India
Erregierre 2417NAI 2025Italy
Bachem 328VAI 2024Switzerland
Shandong Anhong Pharmaceutical 2614VAI 2019China
Siegfried Evionnaz 2614VAI 2023Switzerland
Newchem 1920VAI 2023Italy
COSMA 344VAI 2022Italy
Fresenius Kabi 326NAI 2025Sweden
IOL Chemicals and Pharmaceuticals 1621VAI 2019India
Apicore 351VAI 2025India
Lek Pharmaceuticals 2610NAI 2024Slovenia
Cambrex Charles City 278VAI 2025United States
Concord Biotech 2213VAI 2025India
Hovione Farmaciência 269—Portugal
PolyPeptide 278VAI 2025Sweden
Navinta 311NAI 2024United States
BASF 1714VAI 2025Germany
FDC Limited 1516NAI 2023India
Indena 1219VAI 2021Italy
Shandong Anxin Pharmaceutical 1912VAI 2019China
Zhejiang Guobang 1615VAI 2025China
Hybio Pharmaceutical 255NAI 2025China
Orbion Pharmaceuticals 282—India
Swati Spentose 237VAI 2024India
Viyash Life Sciences 219VAI 2025India
Livzon Group Fuzhou Fuxing Pharmaceutical 1514NAI 2024China
Shouguang Fukang Pharmaceutical 1118VAI 2025China
Zhejiang Apeloa Jiayuan Pharmaceutical 227NAI 2025China
Zhejiang Tianyu Pharmaceutical 1217VAI 2024China

Showing the top 100 of 392. 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
FDA, List of Drug Master Files
Source
EDQM certificate database
Source
FDA inspection classifications

Questions

Why does dual accreditation matter?
Filing the same ingredient in the US and the EU normally means qualifying two dossiers. A supplier holding both an active DMF and a valid CEP has already documented the substance to both regulators, which shortens qualification.
How many suppliers hold both?
392 of 3182, against 1130 holding a US DMF and 579 holding a CEP.
Does this guarantee both markets are open?
No. Accreditation covers the substance and the dossier. Site-level GMP standing and inspection history still apply, which is why the latest FDA inspection outcome is shown on every row.

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Related views

Active FDA Type II DMF holders 1,130 Active CEP holders (EDQM) 579 Suppliers with GMP from 2+ regulators 972

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