PharmaDB
Use case · Supplier Discovery & Qualification · Specialized Manufacturing Capability v.04.2026 · refreshed monthly
Use cases Supplier Discovery & Qualification Specialized Manufacturing Capability
Supplier Discovery & Qualification Buyer view Data · plant capability catalogData · FDA plant register Live

Specialized Manufacturing Capability

Screen suppliers for sterile, oncology, controlled substance, and high-potency capability. The capability-filtered supplier shortlist for complex APIs.

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Example output · palbociclib oncology + sterile capability shortlist
953 Sterile-capable plants across the live catalog · 2026 snapshot
n=953 plants · plant register Indicative

The catalog carries 953 sterile-capable plants and 431 controlled-substance handlers globally. For palbociclib (oncology API, sterile-compatible), the qualifiable Indian cohort includes Gland Pharma, Intas, Indoco Remedies, and NATCO Pharma. The shortlist crosses three filters: sterile or oncology capability, active FDA Type II DMF coverage, and an NAI or VAI-improving inspection class.

# PlantRegionCapabilityAccreditation depthInspection
1 Gland Pharma Hyderabad IN · Hyderabad 3 sterile facilities FDA + EDQM + WHO-PQ overlap NAI
2 Intas Pharmaceuticals Ahmedabad IN · Ahmedabad 2 sterile facilities FDA + EDQM overlap VAI
3 NATCO Pharma Rangareddy IN · Rangareddy 1 sterile facility FDA + EDQM overlap NAI
4 Sun Pharma Halol IN · Halol 2 sterile facilities FDA + EDQM overlap OAI
5 Cipla Salcette IN · Goa 1 sterile facility FDA + EDQM overlap VAI
6 Indoco Remedies Verna IN · Goa 1 sterile facility FDA + EDQM overlap NAI
7 Eugia Pharma Specialities IN · Bhiwadi 1 sterile facility FDA + EDQM overlap VAI
8 Caplin Steriles IN · Gummidipoondi 1 sterile facility FDA + EDQM overlap NAI
Sterile-capable plants (global)
953
Controlled substance handlers
431
Indian sterile cohort
180+
NAI-classed in shortlist
4 of 8
30 seconds

How it works

molecule losartan origin IN destination BR
01

Pick a capability.

Sterile, oncology, high-potency, controlled substance, or specific dosage forms. The AI agent pulls every plant in the capability catalog matching the filter.

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

The AI agent adds the molecule layer.

Where a specific molecule is named, plants with active DMFs on the molecule plus the required capability surface together. Accreditation chips and inspection class join at the schema layer.

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

Save the capability shortlist.

Citation-anchored brief with the qualifying plants, capability chip, accreditation depth, and a chip showing recent inspection class.

Why a buyer runs it

Complex APIs need capability-filtered shortlists.

Capability is the hard filter.

An onco-API needs oncology and often sterile capability at the plant. Without the filter, the supplier shortlist is full of plants that can't actually run the chemistry.

Accreditation overlap on the row.

Capability without accreditation is academic; FDA registration plus EDQM CEP makes the plant commercially actionable. The chip shows the overlap inline.

Inspection class is the safety check.

A sterile plant in OAI is high-risk. Surfacing inspection class on the shortlist prevents speculative qualification work on a plant under enforcement.

Refreshes monthly.

Capability catalog refreshes monthly with new attestations and FDA inspection notes. Coverage transitions propagate on the next refresh.

What a real chat looks like

Type a molecule and capability. The AI agent returns the shortlist.

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

Sterile + oncology · palbociclib
chat · saved 2 min ago
You
Find Indian plants with sterile manufacturing capability for palbociclib supply. Filter to FDA-registered, EDQM-coverage, and clean recent inspection.
F
Running tool pharmagraph_query
plant_capabilities ⋈ plants ⋈ api_docs · capability=sterile · molecule=palbociclib
F
The Indian sterile-capable cohort for an onco-API like palbociclib runs eight plants once the three-criterion filter (sterile capability + FDA + EDQM + recent clean inspection) is applied. Gland Pharma, NATCO Pharma, and Indoco Remedies lead the NAI-classed tier. Sun Pharma Halol carries the capability but the OAI inspection class moves it out of the immediate shortlist.
Palbociclib + sterile Indian shortlist
1 Gland Pharma · NAI · 3 sterile lines FDA + EDQM + WHO-PQ overlap · institutional anchor
2 NATCO Pharma · NAI · oncology heritage FDA + EDQM overlap · onco-portfolio depth
3 Indoco Remedies Verna · NAI · sterile line FDA + EDQM overlap · qualifiable shortlist tier
+5 more · open in PharmaDB
Cited plant_capabilities sterile coverage plant_accreditations FDA + EDQM overlap inspections last 3 cycles
Ask a follow-up... ⌘ ↵
Time-to-answer

Manual workflow vs. PharmaDB.

Manual workflow
Excel · email · syndicated reports
  1. 01 Identify plants with sterile + oncology capability 4-6 hr
  2. 02 Cross-reference FDA Establishment register 2-3 hr
  3. 03 Cross-reference EDQM CEP register 2-3 hr
  4. 04 Pull inspection history per plant 3-4 hr
  5. 05 Compose capability shortlist 2 hr
Total cycle time 2 days per capability filter
PharmaDB
The AI agent · one query · cited
One query.
Pre-joined warehouse. Plant capability catalog, FDA + EDQM accreditation, and inspection class are all keyed on the plant entity. The AI agent returns the shortlist with citation.
Total cycle time Under a minute
Run it across your capability needs

Capability depth, by category.

Plant capability catalog · counts per category and overlap, live snapshot.

Sterile manufacturing (global) deep
953 plants
Controlled substance (global) deep
431 plants
Sterile capable in India adequate
184 plants
Sterile capable in China deep
268 plants
Sterile capable in EU deep
215 plants
Sterile + FDA + EDQM (India) adequate
41 plants
Sterile + FDA + EDQM (China) adequate
27 plants
Sterile + WHO-PQ (any) thin
16 plants
Controlled substance + FDA (India) adequate
32 plants
Oncology API capable (Indian shortlist) adequate
22 plants
BTK / kinase-class capable thin
14 plants
Peptide synthesis capable thin
18 plants
High-potency containment capable adequate
26 plants
Cytotoxic-capable Indian plants thin
11 plants
Sterile + NAI Indian shortlist thin
19 plants
Sterile + OAI plants (watch) thin
4 plants
watch
Thin · < 20 suppliers · qualify additions Adequate · 20–199 Deep · 200+ · negotiable

Specialised manufacturing capability is the hard filter for complex APIs. PharmaDB joins the plant capability catalog to accreditation coverage and inspection class so the capability shortlist is one query, not a multi-source spreadsheet. The view rests on plant_capabilities, plant_accreditations, and inspections. Refresh cadence is monthly.

FAQ

Frequently asked

What capability codes are tracked?+

The current catalog covers sterile manufacturing and controlled substance handling at the plant level. Oncology, high-potency, peptide synthesis, and dosage-form-specific capabilities are tracked as attribute extensions on the same `plant_capabilities` table. New capability codes ingest as new attestation sources publish.

Where does the capability data come from?+

FDA inspection narratives, EDQM CEP scope documents, plant accreditation registers, and primary supplier attestations. PharmaDB carries a confidence flag per capability code; the highest confidence is reserved for regulator-published attestations.

How does this work for biosimilars and peptides?+

Peptide synthesis is its own capability code; biosimilars surface under bioprocessing capability when the plant has fermentation and downstream processing capacity. The headline cohort is small-molecule sterile and controlled substance, but the catalog extends to biologics where the attestation exists.

What if Sun Pharma Halol has the capability but is OAI?+

Capability does not override compliance. Halol carries strong sterile capacity but the OAI inspection class moves it out of the immediate qualifiable shortlist. The chip surfaces both signals so the buyer's decision is informed.

Does this work for FDF plants too?+

Yes. Sterile FDF is a distinct capability code in the catalog. FDF capability layers on top of API capability for plants running both. The molecule-level join then constrains the cohort to plants that actually manufacture the relevant FDF.

How fresh is the data?+

Monthly. Capability catalog refreshes monthly as new attestations publish. The catalog row carries an as-of timestamp on every result page.

Run your question.

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.

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