Drug factory · FDA FEI 3005256484

Aarti Pharmalabs Limited

Unit - IV, Plot No: E - 50, 50/1, 59/1, M.I.D.C. Tarapur, Taluka & District: Palghar, Tarapur, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Mar 27, 2026.

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

5 drug inspections on record since 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
2-Mercaptoethanesulfonic AcidMakes the active ingredient AuroMedics Pharma LLC 55150-520
FluticasoneMakes the active ingredient Morton Grove Pharmaceuticals, Inc. 60432-264
LevalbuterolMakes the active ingredient Aurobindo Pharma Limited 65862-942

FDA inspection history

EndedResultProgramProblems noted
Mar 27, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 20, 2020Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 21, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 27, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 29, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: api manufacture.