Drug factory · FDA FEI 3005122933

Symbiotec Pharmalab Limited

385/2, Pigdamber, Rau, Mhow, Indore, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Apr 3, 2026.

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 2012: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
BetamethasoneMakes the active ingredient Primus Pharmaceuticals, Inc. 68040-714
ClobetasolMakes the active ingredient Primus Pharmaceuticals, Inc. 68040-713
HydrocortisoneMakes the active ingredient Cipla USA., Inc. 69097-004

FDA inspection history

EndedResultProgramProblems noted
Apr 3, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 22, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 13, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
May 12, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 25, 2014No problems foundDrug Quality Assurance—
Jan 20, 2012No problems foundDrug Quality Assurance—

Registered with FDA for: api manufacture.