Drug factory · FDA FEI 1000172912

Biocon Limited

20th KM, Hosur Road, Electronics City, Bengaluru, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 20, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2014: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
FingolimodMakes the active ingredient Biocon Pharma Inc. 70377-019
Mycophenolic AcidMakes the active ingredient Biocon Pharma Inc. 70377-039, 70377-040
RosuvastatinMakes the active ingredient Biocon Pharma Inc. 70377-006, 70377-007, 70377-008 +1

FDA inspection history

EndedResultProgramProblems noted
Sep 20, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 26, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 21, 2018No problems foundDrug Quality Assurance—
Mar 16, 2018Problems found, fixed voluntarilyBioresearch Monitoring—
Aug 19, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
May 2, 2014Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.