Drug factory · FDA FEI 3003144728

Jubilant Biosys Limited

Plot No. 18, 56, 57 &58, KIADB Industrial Area, Nanjangud, Mysuru, India

India: 1

Problems found, fixed voluntarily at FDA's last inspection, Dec 13, 2022.

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 2012: 1 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

DrugRoleForNDC
CarbamazepineMakes the active ingredient Takeda Pharmaceuticals America, Inc. 54092-171, 54092-172, 54092-173
OxcarbazepineMakes the active ingredient, tests it, packages it and labels it Ajanta Pharma USA Inc. 27241-304, 27241-305, 27241-306

FDA inspection history

EndedResultProgramProblems noted
Dec 13, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Dec 18, 2018Serious problems, FDA actionDrug Quality Assurance—
Oct 27, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Oct 16, 2015No problems foundDrug Quality Assurance—
May 31, 2012Problems found, fixed voluntarilyDrug Quality Assurance—

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