Drug factory · FDA FEI 3003803288

Piramal Pharma Limited

Sy.Nos. 7-70, 70/1 and 70/2, Digwal Village, Kohir Mandal, Sangareddy, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Feb 13, 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: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
CinacalcetMakes the active ingredient Slate Run Pharmaceuticals, LLC. 70436-007, 70436-008, 70436-009
IsofluraneMakes it, makes the active ingredient, tests it and packages it Piramal Critical Care Inc. 66794-017
MetyraponeMakes the active ingredient and tests it Esteve Pharmaceuticals, S.a., HRA Pharma Rare Diseases 68118-455, 76336-455
TafenoquineMakes it 60 Degrees Pharmaceuticals, INC. 71475-258
TetrabenazineMakes the active ingredient Slate Run Pharmaceuticals, LLC. 70436-101, 70436-102

FDA inspection history

EndedResultProgramProblems noted
Feb 13, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Mar 31, 2023No problems foundDrug Quality Assurance—
Mar 30, 2018No problems foundDrug Quality Assurance—
Mar 25, 2016No problems foundDrug Quality Assurance—
Jan 20, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 2, 2012No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture; label; manufacture; pack; particle size reduction.