Drug factory · FDA FEI 3004086884

Apitoria Pharma Private Limited

Unit-II, Survey No. 10 & 13, Gaddapotharam Village IDA- Kazipally, Jinnaram Mandal, Sangareddy, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Sep 27, 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 2011: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
Bupivacaine and MeloxicamMakes the active ingredient Heron Therapeutics, Inc. 47426-301, 47426-302, 47426-303 +5
MoxifloxacinMakes the active ingredient and tests it Aurobindo Pharma Limited 65862-840

FDA inspection history

EndedResultProgramProblems noted
Sep 27, 2024Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 25, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Jun 11, 2018No problems foundDrug Quality Assurance—
Jul 1, 2016Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 19, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
May 26, 2011Problems found, fixed voluntarilyDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.