Biocon Biologics 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
- Block No, B1,B2, B3, B5, Q13 of Q1 and W20 & Unit S18,1st Floor,Block B4, SEZ, Plot No.2,3,4&5, Phase IV, Bommasandra-Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3003981475 · DUNS 650501997
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-07-26
- VAIDrug Quality Assurance2019-08-30
- VAIDrug Quality Assurance2018-05-01
- VAIDrug Quality Assurance2017-06-03
- VAIDrug Quality Assurance2015-10-29
- VAIDrug Quality Assurance2015-06-16
- NAIDrug Quality Assurance2012-06-19
- NAIDrug Quality Assurance2012-06-13
- VAIDrug Quality Assurance2009-01-29
Drugs this plant is listed as making
3 distinct drugs across 6 products name this site in their FDA label.
- adalimumab-fkjpBiocon Biologics Inc
- liraglutidein shortageBiocon Pharma Inc.
- trastuzumab-dkstBiocon Biologics 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.