Syngene International 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
- Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)
- Operations here
- analysisapi manufacturemanufacture
- FDA identifiers
- FEI 3003600340 · DUNS 915833842
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-02-20
- NAIDrug Quality Assurance2019-08-21
- NAIDrug Quality Assurance2014-07-11
- NAIDrug Quality Assurance2013-09-18
Drugs this plant is listed as making
3 distinct drugs across 13 products name this site in their FDA label.
- DapagliflozinBiocon Pharma Inc.
- Esmolol HydrochlorideBaxter Healthcare Company
- odevixibatAlbireo 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.