Drug factory · FDA FEI 3009510975

Reliance Life Sciences Private Limited

Dhirubhai Ambani Life Sciences Centre, R-282 Ttc Area of MIDC, Thane Belapur Road, Rabale, , Navi Mumbai, India

India: 1

Serious problems, FDA action at FDA's last inspection, Feb 27, 2026.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

8 drug inspections on record since 2013: 2 with no problems, 4 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

DrugRoleForNDC
AzacitidineMakes it, makes the active ingredient, tests it, packages it and labels it Reliance Life Sciences Private Limited, Somerset Therapeutics, LLC 58458-002, 70069-857
BortezomibMakes it, makes the active ingredient, tests it, packages it and labels it Somerset Therapeutics, LLC, Waverley Pharma Inc 70069-836, 72338-200
CapecitabineMakes it, tests it, packages it and labels it Lifestar Pharma LLC. 70756-815, 70756-816
LenalidomideMakes it and tests it Accord Healthcare Inc. 16729-692, 16729-693, 16729-694 +3
PemetrexedMakes it, makes the active ingredient, tests it, packages it and labels it Somerset Therapeutics, LLC, Waverley Pharma Inc 70069-834, 70069-835, 72338-100 +1

FDA inspection history

EndedResultProgramProblems noted
Feb 27, 2026Serious problems, FDA actionDrug Quality Assurance—
Apr 15, 2022No problems foundBioresearch Monitoring—
Nov 22, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 16, 2018Problems found, fixed voluntarilyDrug Quality Assurance—
Jan 25, 2018No problems foundBioresearch Monitoring—
Dec 13, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 14, 2015Problems found, fixed voluntarilyDrug Quality Assurance—
Aug 23, 2013Serious problems, FDA actionDrug Quality Assurance—

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