PharmaDB
Use case · Supplier Discovery & Qualification · Multi-Regulator Accredited Plants v.04.2026 · refreshed monthly
Use cases Supplier Discovery & Qualification Multi-Regulator Accredited Plants
Supplier Discovery & Qualification Buyer view Data · FDA plant registerData · EDQM CEP register Live

Multi-Regulator Accredited Plants

Surface plants accredited by three or more regulators (FDA, EDQM, WHO-PQ, ANVISA, EMA). The global-supply-ready cohort, joined to molecule footprint.

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Example output · multi-regulator plant shortlist, three-regulator threshold
20 Plants accredited by three or more regulators · 2026 live register
n=20 plants · plant register Authoritative

Twenty plants in the live register hold active accreditations from three or more regulators. Alivira Animal Health (IN, Visakhapatnam), Ami Lifesciences (IN, Vadodara), and Nordmark Pharma (DE) carry FDA + EDQM + WHO-PQ overlap. Fresenius Kabi Austria and Farmhispania (ES) add ANVISA to the mix. The cohort is the global-supply-ready pool: plants that can serve US, EU, and access-market lanes from the same facility.

# PlantRegionRegulatorsRecent inspectionMolecule footprint
1 Alivira Animal Health IN · Visakhapatnam 3 regulators FDA + EDQM + WHO-PQ NAI
2 Ami Lifesciences IN · Vadodara 3 regulators FDA + EDQM + WHO-PQ NAI
3 Nordmark Pharma DE · Uetersen 3 regulators FDA + EDQM + EMA NAI
4 Fresenius Kabi Austria AT · Linz 3 regulators FDA + EDQM + ANVISA NAI
5 Farmhispania ES · Madrid 3 regulators FDA + EDQM + EMA NAI
6 Chongqing Carelife CN · Chongqing 3 regulators FDA + EDQM + WHO-PQ VAI
7 Shandong New Time CN · Shandong 3 regulators FDA + EDQM + ANVISA NAI
8 Shaoxing Jingxin CN · Shaoxing 3 regulators FDA + EDQM + WHO-PQ VAI
Tri+ regulator plants
20
Indian plants in cohort
5
Chinese plants in cohort
6
NAI-classed share
85%
30 seconds

How it works

molecule losartan origin IN destination BR
01

Set the regulator threshold.

Default is three or more active regulators per plant. Buyers can tune to four-plus or to specific regulator combinations.

0 HHI 0.42 1
computed · pre-joined · anonymised
02

The AI agent resolves the plant cohort.

Each plant's regulator coverage is computed from the canonical accreditation catalog. Inspection class and molecule footprint join at the schema layer.

brief · cited
Lane concentration · structurally concentrated
HHI0.42
Top-3 share71%
Actionqualify second source
03

Save the global-supply shortlist.

Citation-anchored brief with the qualifying plants, regulator chips, inspection class, and a molecule-footprint summary.

Why a buyer runs it

One plant, many markets, one qualification.

Multi-market in one supplier.

A plant accredited by FDA + EDQM + WHO-PQ can ship into US, EU, and access markets from the same facility. The buyer qualifies once and serves three regulatory geographies.

Regulator coverage is a quality proxy.

Plants that maintain three or more active accreditations are signalling sustained quality-system investment. The regulator-coverage chip is a leading indicator of audit readiness.

Footprint context built in.

Regulator coverage matters only if the plant manufactures relevant molecules. The footprint chip surfaces the matched molecule count per plant for the buyer's portfolio.

Refreshes monthly.

Accreditation registers publish monthly. Coverage transitions (lapses, new issuance) propagate on the next refresh; the catalog row carries an as-of timestamp.

What a real chat looks like

Type a threshold. The AI agent returns the multi-regulator cohort.

A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.

Multi-regulator plants
chat · saved 2 min ago
You
Surface plants accredited by three or more regulators (FDA, EDQM, WHO-PQ, ANVISA, EMA). Rank by molecule footprint and recent inspection class.
F
Running tool pharmagraph_query
plant_accreditations ⋈ plants · distinct regulators >= 3 · status=active
F
Twenty plants currently hold three or more active regulator accreditations. The Indian cohort (Alivira, Ami Lifesciences, Micro Labs) carries FDA + EDQM + WHO-PQ; the European cohort (Nordmark, Fresenius Kabi Austria, Farmhispania) carries FDA + EDQM + EMA or ANVISA. The Chinese cohort (Carelife, Shandong New Time, Shaoxing Jingxin) signals global-supply ambition. Buyers running multi-market sourcing qualify once and serve multiple geographies.
Tri-regulator plants · global
1 Alivira Animal Health · IN · NAI FDA + EDQM + WHO-PQ · Visakhapatnam · molecule-deep
2 Ami Lifesciences · IN · NAI FDA + EDQM + WHO-PQ · Vadodara · qualifiable for global supply
3 Nordmark Pharma · DE · NAI FDA + EDQM + EMA · European anchor
+17 more · open in PharmaDB
Cited plant_accreditations tri+ regulators plants 20 plants inspections last 3 cycles
Ask a follow-up... ⌘ ↵
Time-to-answer

Manual workflow vs. PharmaDB.

Manual workflow
Excel · email · syndicated reports
  1. 01 Pull each regulator's accreditation register 1 day
  2. 02 Resolve plant names to canonical plant entities 6-8 hr
  3. 03 Compute regulator-overlap counts 2-3 hr
  4. 04 Join inspection class and molecule footprint 4-6 hr
  5. 05 Compose qualification-ready brief 3-4 hr
Total cycle time 3-4 days
PharmaDB
The AI agent · one query · cited
One query.
Pre-joined warehouse. All regulator accreditation registers are pre-resolved to the canonical plant catalog. The AI agent returns the multi-regulator cohort with citation in one response.
Total cycle time Under a minute
Run it across your portfolio

Regulator coverage depth, by cohort.

Plant cohort · counts by regulator-overlap category, live register 2026.

Tri+ regulator plants adequate
20 plants
FDA + EDQM deep
142 plants
FDA + WHO-PQ adequate
38 plants
EDQM + WHO-PQ adequate
29 plants
FDA + ANVISA deep
198 plants
EDQM + ANVISA deep
84 plants
FDA + EMA deep
117 plants
FDA + ZLG / BfArM deep
91 plants
Indian plants FDA + EDQM deep
67 plants
Chinese plants FDA + EDQM adequate
41 plants
European plants tri+ adequate
8 plants
Indian plants WHO-PQ thin
4 plants
thin
Chinese plants WHO-PQ adequate
7 plants
Quad-accredited plants thin
3 plants
very thin
Plants with NAI + tri+ regulator adequate
17 plants
Thin · < 5 suppliers · qualify additions Adequate · 5–49 Deep · 50+ · negotiable

Multi-regulator accredited plants are the global-supply tier. PharmaDB joins every regulator’s accreditation register to the canonical plant catalog, computes overlap counts, and surfaces the qualifying cohort with inspection class and molecule footprint. The view rests on plant_accreditations joined to plants and inspections. Refresh cadence is monthly.

FAQ

Frequently asked

Why three regulators as the threshold?+

Three is operationally meaningful: a plant maintaining FDA + EDQM + a third major regulator (WHO-PQ, EMA, ANVISA) demonstrates audit readiness for multi-market commercial supply. Two-regulator plants are common; three-regulator plants are the visible global-supply tier.

Are GMP-only accreditations included?+

Yes. Plants with active GMP certificates from each regulator surface. GMP is the floor; specific product-level certificates (CEP for EU, WHO-PQ for institutional) layer on top. The regulator-overlap count is GMP-anchored unless a buyer opts into product-level filtering.

How current are the regulator chips?+

Monthly. Each regulator's accreditation register publishes on a different cadence (FDA continuous, EDQM monthly, WHO-PQ quarterly, ANVISA continuous). PharmaDB normalises to a monthly catalog refresh; the catalog row carries an as-of timestamp.

What about lapsed accreditations?+

Lapsed and suspended accreditations are excluded from the active count by default. The historical view is queryable for diligence work but does not contribute to the multi-regulator chip on the live shortlist.

Can a plant carry the same regulator's accreditation twice (for different molecules)?+

Counts collapse to the distinct-regulator level. A plant with twenty EDQM CEPs counts EDQM once. The molecule footprint metric surfaces the volume separately for buyers who care about product-level coverage.

How does this connect to dual-accredited views?+

Dual-Accredited Plants (FDA + EDQM) is the most common two-regulator combination and gets a dedicated view because of its specific use in trans-Atlantic supply. The tri+ view is the rarer, more demanding tier.

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