Unichem Laboratories 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
- Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa 403511, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3005497507 · DUNS 915389741
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-07-15
- VAIDrug Quality Assurance2020-01-12
- VAIDrug Quality Assurance2019-07-31
- VAIDrug Quality Assurance2015-04-17
- VAIDrug Quality Assurance2012-04-06
- VAIDrug Quality Assurance2009-05-15
Drugs this plant is listed as making
7 distinct drugs across 21 products name this site in their FDA label.
- CarbamazepineUnichem Pharmaceuticals (USA), Inc.
- divalproex sodiumBluePoint Laboratories
- Methenamine HippurateJubilant Cadista Pharmaceuticals Inc.
- Metronidazolein shortageBluePoint Laboratories
- QuetiapineUnichem Pharmaceuticals (USA), Inc.
- RanolazineUnichem Pharmaceuticals (USA), Inc.
- ZonisamideUnichem Pharmaceuticals (USA), 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.