Biocon 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
- Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India (IND)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3010164491 · DUNS 915076162
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-27
- VAIDrug Quality Assurance2020-01-24
- NAIDrug Quality Assurance2016-07-08
Drugs this plant is listed as making
3 distinct drugs across 12 products name this site in their FDA label.
- everolimusNorthStar RxLLC
- PosaconazoleBiocon Phama Inc.
- TacrolimusBiocon Pharma 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.