Who holds Europe's API certificates?
A Certificate of Suitability (CEP) is the EDQM credential a substance maker holds to supply the EU-regulated market. Across 7,646 valid CEPs held by 1,592 companies, the map has a twist: China has the most holders, but India holds more than twice as many certificates. Europe's own supply credential leans heavily on Asia.
Data as of September 2026 · Source: EDQM Certification database (Certificates of Suitability) · Analysis by PharmaTek Intelligence
Key findings
China leads by company count, India by certificate volume
China has the most CEP holders (441), narrowly ahead of India (382). But by certificates the picture inverts: India holds 3,067 valid CEPs to China's 1,410. Indian holders average roughly 8 CEPs each against China's 3 — a signal of broad, multi-product generic-API portfolios built around EU-market supply.
Europe's own supply credential is concentrated in Asia
China and India together account for 52% of all CEP holders and 59% of valid certificates. The next tier is European — Germany, Italy, Spain and France — but each is a fraction of the Asian base. For a substance certified to the European Pharmacopoeia, the realistic certified sources most often sit outside Europe.
One in five certificates on the register is no longer current
Of 9,577 CEPs on the register, 1,931 (20%) are withdrawn by the holder, expired or suspended. A CEP number on a specification or a supplier's brochure is not evidence of a current certificate — status has to be checked, not assumed. It is the same trap as reading a GMP certificate by its issue date alone.
CEP holders by country
Top 12 countries by number of companies holding at least one valid Certificate of Suitability. Country is the holder's headquarters, not the site of manufacture.
Highlighted: China (most holders) and India (most certificates). Measured by distinct companies with a valid CEP.
The most-certified substances
The active ingredients with the widest choice of CEP-certified sources — the most commoditised generic APIs, where a sourcing team has the most room to compare and second-source.
What this means for sourcing teams
A CEP answers a narrow, useful question: has the EDQM confirmed that a maker's substance can be controlled by the relevant European Pharmacopoeia monograph, so it can support an EU marketing authorisation? It is a strong market-access credential. It is not a statement that the holder is the manufacturer, nor a GMP clearance — the same distinction that makes a Drug Master File a supply credential rather than a quality verdict.
The geography is the headline. Where a substance is certified for the EU market, it is most often certified from China or India — and the two are not interchangeable. China's base is broad in company count; India's is deep in certificate volume per holder. That shapes the second-source question: for a commoditised molecule like rivaroxaban there are dozens of certified sources to compare, while a thinly-certified substance may have only one or two — a difference worth knowing before, not after, a supply shock. Our single vs dual sourcing guide covers when the second source earns its cost.
Finally, currency matters. One in five CEPs on the register is no longer valid, so a certificate number is a prompt to check status, not a guarantee. This mirrors the reading problem with GMP evidence, covered in what a GMP certificate actually tells you. For the manufacturing-site view that complements this certificate view, see our API manufacturing geography report.
PharmaTek links every valid CEP to its holder's company profile and its substance, so “who is certified to supply this API into the EU” is a filter rather than a database-by-database search. Explore the API directory.
Methodology & sources
- Base: the EDQM public Certification database as of September 2026 — 9,577 Certificates of Suitability, of which 7,646 are valid (the remainder withdrawn by the holder, expired or suspended). Counts of holders and substances use valid certificates only.
- A holder is the company named on the certificate. Per the EDQM, the database is not a directory of manufacturers — a CEP holder is not necessarily the manufacturer of the substance, and this report makes no such claim.
- Geography is the holder's headquarters country as published by the EDQM, not the site of manufacture. Companies with more than one certificate are counted once per country.
- A CEP certifies suitability of a monograph for a substance; it is a European market-access credential, not a certificate of GMP compliance and not an approval of any finished product. Source: EDQM certification database, reused with permission and attribution.
Cite this report: PharmaTek Intelligence, “Who Holds Europe's API Certificates?” September 2026. https://pharmatek.co.uk/reports/eu-cep-supplier-geography
This report describes the CEP holder base in aggregate and makes no judgement about any individual company or certificate. Certificate status changes over time; always confirm a CEP and its current status against the EDQM database before a sourcing decision.
Find CEP-certified API suppliers
Search substances by their certified sources — CEP and US DMF evidence linked to each company profile, alongside FDA compliance history.
Explore the API directory