Plants holding both FDA registration and active EDQM CEP coverage. The trans-Atlantic supply pool, ready for US and EU sourcing from the same facility.
More than 640 plants in the live register carry both active FDA registration and at least one EDQM CEP. The Indian cohort dominates the volume tier (Apex Healthcare, Anuh Pharma, Apicore, Ami Lifesciences, BGP Healthcare). The Chinese cohort grew through the late 2010s and now spans Anqiu Lu'an, Changzhou Pharmaceutical, Chongqing Carelife, and the Hubei / Hebei cluster. European plants (Arevipharma, Bachem) anchor the high-spec tier. The pool is the trans-Atlantic supply default for any buyer running both US and EU sourcing.
| # | Plant | Region | Active CEPs | FDA inspection | Trans-Atlantic ready |
|---|---|---|---|---|---|
| 1 | Macleods Pharmaceuticals | IN · Mumbai | 52 CEPs | NAI most recent | VAI |
| 2 | Micro Labs | IN · Bengaluru | 42 CEPs | NAI most recent | NAI |
| 3 | Chromo Laboratories | IN · Hyderabad | 27 CEPs | VAI most recent | VAI |
| 4 | MSN Pharmachem | IN · Hyderabad | 19 CEPs | VAI most recent | VAI |
| 5 | Centaur Pharmaceuticals | IN · Pune | 19 CEPs | NAI most recent | NAI |
| 6 | Arevipharma GmbH | DE · Radebeul | 21 CEPs | NAI most recent | NAI |
| 7 | Ami Lifesciences | IN · Vadodara | 16 CEPs | NAI most recent | NAI |
| 8 | Changzhou Pharmaceutical Factory | CN · Changzhou | 12 CEPs | VAI most recent | VAI |
All dual-accredited plants, geography-specific, or molecule-specific. The AI agent pulls the cohort matching the filter.
Each plant's FDA registration and EDQM CEP coverage is cross-resolved against the canonical plant catalog. Inspection class and molecule footprint join at the schema layer.
Citation-anchored brief with the qualifying plants, CEP count, inspection class, and molecule-coverage chip.
Dual-accredited plants can serve both US ANDA filings and EU MA applications from the same facility. The buyer qualifies once and runs both pathways.
Maintaining both FDA registration and EDQM CEP requires sustained investment in dual-system QA. Dual coverage is a leading indicator of audit readiness on either side.
Plants with 20+ active CEPs have scaled their EU presence across many molecules. Plants with one or two CEPs may be entering. The chip surfaces the depth.
FDA continuous and EDQM monthly registers normalise to a monthly catalog refresh. Coverage transitions propagate on the next refresh.
A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.
pharmagraph_query Live dual-accredited cohort · counts by country and CEP-density band.
Dual-accredited (FDA + EDQM) plants are the default trans-Atlantic supply pool. PharmaDB cross-resolves the FDA registration and EDQM CEP registers at the canonical plant catalog and surfaces the qualifying cohort with inspection class. The view rests on plant_accreditations and plants. Refresh cadence is monthly.
It's the most commercially material combination: the US and the EU are the two largest regulated generics markets. A plant with both accreditations is ready to serve more than 60 percent of regulated-market API demand from a single facility.
The plant has an active FDA Establishment Identifier (FEI) and is registered as a drug manufacturer with the FDA. It does not by itself mean every product made there is approved; that's the DMF / ANDA layer. The plant-level FDA chip indicates the facility is in the FDA's surveillance pool.
The cohort is mixed. Older anchor plants (Changzhou Pharmaceutical, Chongqing Carelife) carry VAI or NAI; some newer entrants are still in VAI as they mature their CAPA function. PharmaDB surfaces inspection class on every row so buyers see the mix.
Dual FDA + EDQM is the most common two-regulator combination. The multi-regulator view (three or more accreditations) is a stricter superset; plants in the tri+ tier all carry FDA + EDQM as the floor.
Yes. The cohort uses GMP-level FDA registration and any active EDQM CEP. Product-level filtering (specific DMF, specific CEP) is a layer on top, queryable through the AI agent with the same prompt structure.
Monthly. FDA registration is continuous; EDQM CEP register publishes monthly. PharmaDB normalises to a monthly catalog refresh; the catalog row carries an as-of timestamp.
Bring the molecule, the lane, or the supplier you're sourcing this week. The AI agent runs it on PharmaDB in 30 minutes. You keep the brief.