CEP / EDQM API Supplier to the European Union and United Kingdom
Multiple active EDQM Certificates of Suitability (CEPs) plus full Active Substance Master File (ASMF) dossiers for non-CEP APIs. Ph. Eur. release on every batch. Audit-ready CMC packages for EMA centralised, decentralised, and national procedures, plus UK MHRA filings under the UKMA pathway.
CEP vs ASMF — which does your filing need?
For an API destined for an EU marketing authorisation, you need one of:
- A Certificate of Suitability (CEP) issued by EDQM — confirms the API complies with the European Pharmacopoeia (Ph. Eur.) monograph. Citable directly in a Module 3 (CTD) filing without further CMC documentation.
- An Active Substance Master File (ASMF) — the European equivalent of a US DMF. Two parts: an “Applicant’s Part” (you submit) and a “Restricted Part” (we submit confidentially) — referenced via a Letter of Access.
We hold active CEPs for our workhorse molecules and maintain ASMFs for all other APIs we supply into the EU. Choose whichever route fits your filing strategy.
Coverage by therapeutic area
- Cardiovascular — antihypertensives, statins, antiarrhythmics
- Anti-infectives — beta-lactams, fluoroquinolones, antifungals
- CNS — antiepileptics, antidepressants, anxiolytics, antipsychotics
- Oncology — cytotoxic and targeted small molecules
- Endocrine — antidiabetics, thyroid hormones, corticosteroids
- Gastrointestinal — PPIs, H2 blockers, prokinetics
- Respiratory — bronchodilators, leukotriene antagonists
Browse the Europe market page for procurement workflows, or filter the Human APIs catalogue by therapeutic area on the catalogue.
Brexit, UKMA, and the Northern Ireland Protocol
For UK-bound shipments since 1 January 2024, an API needs either:
- An EU CEP (still recognised by MHRA under the Windsor Framework), or
- A separate MHRA-accepted ASMF citation in a UKMA filing.
Northern Ireland follows EU procedures under the Protocol. Our supply documents reference both jurisdictions explicitly so buyers don’t have to re-paper for cross-border movement within the UK.
Explore the catalogue
Frequently asked questions
Do you supply Ph. Eur. or USP grade by default?
Both. The grade is selected at order entry and reflected on the CoA. For EU buyers we default to Ph. Eur. with USP secondary specs released on request; for US buyers we flip the default. JP-grade release is available where the JP has a monograph for the molecule.
Are your facilities EDQM-inspected?
Yes. EDQM site inspections are conducted as part of the CEP renewal cycle. The most recent EDQM inspection of our Pune facility closed without any critical or major observations.
How do you handle the EU’s Falsified Medicines Directive (FMD)?
Our QPs are familiar with the FMD’s active-substance importation requirements. We issue a written confirmation (per Article 46b) attesting that the API was manufactured under GMP equivalent to EU GMP for every shipment entering the EU.
What CEP numbers do you hold?
CEP numbers are issued individually per molecule. Contact us with the API name or INN you need and we’ll respond with the active CEP reference within 24 hours, plus the most recent renewal date.
Talk to a sales engineer
First response within 4 business hours, Pune time (IST). We can also run a teams call inside your working hours — most weekday hours across the US, EU, LATAM and APAC are covered.