Find every active EDQM Certificate of Suitability holder for a target molecule. Joined to plant attribution, regulator overlap, and EU export volume.
Macleods Pharmaceuticals leads the EDQM register with 52 active CEPs, followed by Jubilant Biosys (44) and Micro Labs (42). The top of the leaderboard is a mix of Indian volume players and European specialty houses (Aspen Oss, Amino GmbH, Macfarlan Smith). Olmesartan-specific CEPs concentrate in Apitoria Pharma and CTX Lifesciences, both Indian plants with parallel FDA Type II filings.
| # | Holder | Plant country | Active CEPs | Most recent issue | FDA overlap |
|---|---|---|---|---|---|
| 1 | Macleods Pharmaceuticals | IN · multiple | 52 active | 2026-Q1 | VAI |
| 2 | Jubilant Biosys | IN · Bangalore | 44 active | 2025-Q4 | NAI |
| 3 | Micro Labs | IN · Bengaluru | 42 active | 2025-Q4 | NAI |
| 4 | Sintetica S.A. | ES · Couvet | 31 active | 2025-Q3 | NAI |
| 5 | Chromo Laboratories India | IN · Hyderabad | 27 active | 2025-Q3 | VAI |
| 6 | Aspen Oss B.V. | NL · Oss | 23 active | 2025-Q3 | NAI |
| 7 | Amino GmbH | DE · Frellstedt | 22 active | 2025-Q2 | NAI |
| 8 | Arevipharma GmbH | DE · Radebeul | 21 active | 2025-Q2 | NAI |
Type the INN. The AI agent matches against the EDQM CEP register and returns the active-only cohort by holder.
Each CEP is linked to its issuing plant. Plant accreditation overlap with FDA, WHO-PQ, ANVISA surfaces as a chip.
Citation-anchored brief with holder, plant, CEP count, issue date, and accreditation overlap. Hand off to qualification.
Withdrawn and suspended CEPs are excluded by default. The list is the pool that can lawfully supply EU markets today.
FDA + EDQM dual-accredited plants are the natural shortlist for trans-Atlantic supply. The chip surfaces both accreditations on one row.
Indian volume holders sit alongside European specialty houses. Country chip lets a buyer split shortlists by sourcing strategy.
The EDQM CEP register refreshes monthly. Newly issued, withdrawn, and suspended status changes propagate on the next refresh.
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pharmagraph_query Portfolio view, active EDQM CEPs per molecule, live register, 2026 snapshot.
The EDQM CEP register is the EU equivalent of the FDA DMF, the first signal that a manufacturer can lawfully supply an API into Europe. PharmaDB joins the register to plant attribution, FDA overlap, and inspection class, so the list is action-ready, not paper alone. The underlying table is plant_accreditations with cert_type='edqm_cep'; the join is to plants and inspections. Refresh cadence is monthly.
A Certificate of Suitability to the monographs of the European Pharmacopoeia, issued by the EDQM. It confirms that a manufacturer's API meets the Ph. Eur. monograph and can be referenced in Marketing Authorisation applications across the EU and CEP-recognising countries.
A CEP is an EDQM-issued certificate against Ph. Eur. monograph compliance, while a Type II DMF is a confidential dossier filed with the FDA. Many large API manufacturers maintain both, since the regulatory pathways are distinct but the underlying manufacturing facility is the same.
Indian API manufacturers built EDQM capability through the 2010s to serve European generics formulators. The register today shows Indian plants holding ~45 percent of active CEPs, led by Macleods, Jubilant Biosys, and Micro Labs.
EDQM publishes the certificate-holder and the manufacturing site. PharmaDB resolves both against the canonical plant catalog, so each CEP row carries plant city, country, and FEI when the site overlaps with the FDA register.
Withdrawn and suspended CEPs are excluded from the active list by default. They remain queryable as a historical view for diligence work but are not part of the supplier shortlist.
Monthly. The EDQM register publishes status updates monthly. The catalog row carries a last-computed timestamp for every result page.
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