Alembic Pharmaceuticals Limited
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- Survey No. 84,87 and 88, Panelav, Taluka Halol, Panchmahal, Gujarat 389350, India (IND)
- Operations here
- manufacture
- FDA identifiers
- FEI 3014866088 · DUNS 675480402
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-08
Drugs this plant is listed as making
13 distinct drugs across 61 products name this site in their FDA label.
- BosutinibAlembic Pharmaceuticals Inc.
- CarmustineAlembic Pharmaceuticals Limited
- CyclophosphamideAlembic Pharmaceuticals Inc.
- DasatinibAlembic Pharmaceuticals Limited
- DocetaxelAlembic Pharmaceuticals Limited
- doxorubicin hydrochlorideAlembic Pharmaceuticals Limited
- Erlotinib HydrochlorideAlembic Pharmaceuticals Inc.
- FingolimodAlembic Pharmaceuticals Inc.
- FluorouracilAlembic Pharmaceuticals Limited
- Methotrexatein shortageAlembic Pharmaceuticals Limited
- nelarabineAlembic Pharmaceuticals Limited
- PaclitaxelAlembic Pharmaceuticals Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.