Drug factory · FDA FEI 3004161218

Dishman Carbogen Amcis Limited

Survey No. 47 & 48, Paiki Sub plot No. 1, Village- Lodariyal, Taluka - Sanand, Ahmedabad, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 7, 2024.

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

4 drug inspections on record since 2012: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BedaquilineMakes the active ingredient Janssen Products LP 59676-701, 59676-702

FDA inspection history

EndedResultProgramProblems noted
Mar 7, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 26, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 8, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 17, 2012Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.