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
- Plot No. 213-215 and 216/B, Phase II IDA, Pashamylaram, Sangareddy, Telangana 502307, India (IND)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3004956855 · DUNS 916728337
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-05-19
- NAIDrug Quality Assurance2018-12-14
- NAIDrug Quality Assurance2014-06-06
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- DapagliflozinBiocon 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.