Surface plants with controlled-substance handling capability. 431 plants indexed across 28 countries, joined to inspection class and capability footprint.
The catalog indexes 431 plants with controlled-substance handling capability across 28 countries. India dominates with 279 plants; the US carries 36; Italy 22; China 21; Germany 13. The capability code reflects plant-level authorisation to handle scheduled molecules under the relevant national framework (DEA, NDPS, narcotic-licence equivalents). Joined to FDA inspection class, the cohort splits into qualifiable-clean (NAI plants, the deepest sourcing pool) and the broader VAI cohort that requires additional CAPA evidence at qualification.
| # | Country | Capability cohort | Plants | Inspection-clean subset | Notable capability stack |
|---|---|---|---|---|---|
| 1 | India | NDPS Act framework | 279 plants | API + sterile common | VAI |
| 2 | United States | DEA registration | 36 plants | FDF + oral solid | VAI |
| 3 | Italy | AIFA controlled-substance | 22 plants | API + extract | VAI |
| 4 | China | NMPA controlled-substance | 21 plants | API focus | VAI |
| 5 | Germany | BtMG framework | 13 plants | API + FDF | VAI |
| 6 | Brazil | Anvisa controlled-substance | 12 plants | FDF dominant | VAI |
| 7 | Switzerland | SwissMedic framework | 7 plants | API + sterile | NAI |
| 8 | Spain | AEMPS framework | 7 plants | API focus | VAI |
| 9 | Canada | Health Canada CDSA | 6 plants | API + FDF | VAI |
| 10 | France | ANSM controlled-substance | 4 plants | FDF | VAI |
Controlled-substance handling is the default. Stack with sterile, oncology, biotech, or high-potency if the molecule needs multiple capabilities at the same plant.
Plants with the capability code present, joined to inspection class and active enforcement. Country, regulator, and capability-stack filters available.
Citation-anchored cohort with the capability footprint, the inspection chip, and the corporate-parent resolution per plant.
Controlled-substance handling, sterile manufacturing, oncology, biotech, high-potency. Each plant carries a capability stack so a buyer can match a portfolio molecule to the right infrastructure.
Capability without compliance is not useful. The cohort is filtered to qualifiable plants (NAI or VAI without active enforcement) by default; the full cohort is available for the BD-acquisition view.
India dominates the controlled-substance cohort by plant count. US and Italy lead by qualifiable-clean share. The cohort splits cleanly by country regulatory framework.
Sterile-capable controlled-substance plants are roughly 120 across the catalog. Oncology-capable controlled-substance plants are a tighter cohort. The stack filter narrows the shortlist to the molecule-specific requirement.
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pharmagraph_query Approximate plant counts by capability stack · the controlled-substance cohort intersected with other manufacturing capabilities · live warehouse.
The controlled-substance discovery view is the capability and compliance shortlist for scheduled-molecule sourcing. PharmaDB joins capability codes to inspection class and corporate-parent attribution at the plant level. The view is plant_capabilities filtered to capability_code = 'controlled_substance' joined to inspections and plants. Refresh cadence is quarterly for capability codes, weekly for inspections.
Plant-level authorisation to handle scheduled molecules under the relevant national framework (DEA in the US, NDPS Act in India, BtMG in Germany, equivalents elsewhere). The capability code is set per plant and reflects active authorisation, not historical permits.
Three reasons. Long-standing NDPS Act authorisation embedded in the broader API manufacturing infrastructure. Strong integration with global supply chains for opiate and cannabinoid derivatives. Cost structure that makes controlled-substance handling economically viable at scale. The Indian plant pool is roughly 65% of the global controlled-substance cohort.
No. A plant can be capability-authorised and inspection-failing simultaneously. The cohort is filtered to qualifiable plants (NAI or VAI without active enforcement) by default. The full capability cohort, including OAI and enforcement-flagged plants, is available for the BD-acquisition view but not as a sourcing shortlist.
Capability codes refresh quarterly because the underlying registration data updates on long cycles. Inspection class refreshes weekly. The cohort row carries the capability-code as-of date separately from the inspection chip.
Yes. The stack filter narrows the cohort to the molecule-specific requirement. Sterile-capable controlled-substance plants are roughly 120 globally; oncology-capable controlled-substance plants are roughly 38. The stack filter is the standard CMO-search starting point for specialty molecules.
The capability cohort is independent of DMF status. Joining to active DMF surfacing requires the molecule filter; the combined query returns the capable, inspection-clean, DMF-active cohort per molecule. The standard sourcing decision joins all three.
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