Who holds EU Certificates of Suitability?
A Certificate of Suitability (CEP) is issued by the EDQM. A Chemical CEP confirms that a substance's quality can be controlled by its European Pharmacopoeia monograph; a TSE CEP covers TSE-risk requirements for materials such as gelatin, not chemical purity. The holder is not necessarily the manufacturer. Across 7,584 valid CEPs (6,997 Chemical) held by 1,589 holders, China has the most holders, but India holds more than twice as many certificates, and the same is true of Chemical certificates alone.
Data as of 23 October 2026 · Source: EDQM Certification database (Certificates of Suitability) · Analysis by PharmaTek Intelligence
Reviewed by Dr Sanaz Baheran, PhD in pharmaceutical science, co-founder of PharmaTek
Key findings
China leads by company count, India by certificate volume
China has the most CEP holders (446), narrowly ahead of India (380). But by certificates the picture inverts: India holds 3,045 valid CEPs to China's 1,396. 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.
Most valid certificates are held in China or India
China and India together account for 52% of all CEP holders and 59% of valid certificates (62% of Chemical certificates). The next tier is European (Germany, Italy, Spain and France), each a fraction of that. Holder country is where the holder is registered, not where the substance is made.
One in five certificates on the register is no longer current
Of 9,522 CEPs on the register, 1,938 (20%) are withdrawn by the holder, expired or suspended.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.
What kind of certificate
The EDQM register is not only an API register. Counts in this report cover every certificate type; the dataset splits them so a Chemical-only analysis can be run.
| Type | What it certifies | Valid |
|---|---|---|
| Chemical | The substance's quality can be controlled by its European Pharmacopoeia monograph | 6,997 |
| TSE | Compliance with the Ph. Eur. requirements on TSE risk (animal-derived materials such as gelatin); not chemical purity | 435 |
| Chemical and TSE | Both of the above | 88 |
| Herbal | Herbal drugs and herbal drug preparations | 64 |
CEP holders by country
Top 12 countries by number of holders with at least one valid Certificate of Suitability (any type). Country is the holder's registered country as EDQM records it, not the site of manufacture.
Highlighted: China (most holders) and India (most certificates). Measured by distinct companies with a valid CEP.
Substances with the most CEP holders
The active substances with the most valid CEP holders in this edition, usually the most commoditised generic APIs. Live counts are on each substance page.
What this means for sourcing teams
A Chemical CEP answers a narrow, useful question: has the EDQM confirmed that a substance's quality can be controlled by the relevant European Pharmacopoeia monograph, so the certificate can support an EU marketing authorisation? A TSE CEP answers a different one, about TSE risk. 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 has a CEP, the holder is most often based in 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 CEP holders to compare, while another 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 shows every valid CEP on its substance page, linked to the holder's company profile where the match is exact, so “who holds a CEP for this API” is one lookup rather than a database-by-database search. A holder is not necessarily the manufacturer. Explore the API directory.
Reproduce this report
This is the 23 October 2026 edition. It counts only the latest revision of each certificate number (a transferred or renewed CEP keeps its number), so a holder of a superseded revision is not counted. The September 2026 edition counted every revision marked valid: 7,646 valid CEPs and 1,592 holders. Data, query and limitations
Methodology & sources
- Base: the EDQM public Certification database as of 23 October 2026 — 9,522 Certificates of Suitability (latest revision of each), of which 7,584 are valid (the remainder withdrawn by the holder, expired or suspended). Counts of holders and substances use valid certificates only and include every certificate type: 6,997 Chemical, 435 TSE, 88 Chemical and TSE, 64 Herbal. India's and China's positions hold for Chemical certificates alone (India 3,027, China 1,342).
- 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 country as published by the EDQM, not the site of manufacture. Holders are counted by the holder name EDQM records; a holder with several certificates is counted once per country, and one company with differently named holder entries can count more than once.
- A Chemical CEP certifies that a substance's quality can be controlled by its Ph. Eur. monograph; a TSE CEP certifies compliance with the TSE-risk requirements; a Herbal CEP covers herbal drugs. None is a certificate of GMP compliance or an approval of a finished product.
- Source: Certification Online Database, European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, 2026 — extranet.edqm.eu. Reproduced with permission; the data is presented unaltered. The EDQM and the Council of Europe accept no liability for any consequence arising from its use.
Cite this report: PharmaTek Intelligence, “Who Holds EU Certificates of Suitability?” 23 October 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 holders for any API
Search any substance for its current CEP and US DMF holders, with sources and dates, alongside FDA enforcement records.
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