Biocon Sdn.bhd.
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
- Malaysia
- Registered address
- No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, Iskander Puteri, Johor 79200, Malaysia (MYS)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3011248248 · DUNS 865785591
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-27
Drugs this plant is listed as making
3 distinct drugs across 7 products name this site in their FDA label.
- insulin aspart-xjhzBiocon Biologics Inc.
- insulin glargine-yfgnCivica, Inc.
- waterin shortageBiocon 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.