Drug factory · FDA FEI 3006767695

Apicore Pharmaceuticals Private Limited

Block No. 252-253, Village - Dhobikuva, Opposite Jain Irrigation, Padra - Jambusar Highway, Tal. Padra., Vadodara, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, May 5, 2023.

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 2011: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
PomalidomideMakes the active ingredient, tests it and sterilizes it Aurobindo Pharma Limited 59651-194, 59651-195, 59651-196 +1

FDA inspection history

EndedResultProgramProblems noted
May 5, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 8, 2019No problems foundDrug Quality Assurance—
Jan 25, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 25, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 13, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 12, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; relabel; repack; sterilize.