Drug factory · FDA FEI 3012664809

Ajanta Pharma Limited

Plot No. Z-103 /A Dahej SEZ - Part II, Bharuch, India

India: 1

No problems found at FDA's last inspection, Jun 23, 2023.

No Action Indicated: inspectors found no objectionable conditions.

3 drug inspections on record since 2018: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AlmotriptanMakes it Ajanta Pharma USA Inc. 27241-041, 27241-042
Bicarbonate Ion and OmeprazoleMakes it Ajanta Pharma USA Inc. 27241-029, 27241-030
BrexpiprazoleMakes it Ajanta Pharma USA Inc. 27241-204, 27241-205, 27241-206 +3
CarbamazepineMakes it Ajanta Pharma USA Inc. 27241-231, 27241-232, 27241-233
ChlorthalidoneMakes it Ajanta Pharma USA Inc. 27241-216, 27241-217
CholestyramineMakes it Ajanta Pharma USA Inc. 27241-134
ClomipramineMakes it Ajanta Pharma USA Inc. 27241-210, 27241-211, 27241-212
DapagliflozinMakes it Ajanta Pharma USA Inc. 27241-151, 27241-152
DoxepinMakes it Ajanta Pharma USA Inc. 27241-167, 27241-168, 27241-169 +4
DoxycyclineMakes it Ajanta Pharma USA Inc. 27241-140, 27241-141, 27241-153 +1
DuloxetineMakes it Ajanta Pharma USA Inc., BluePoint Laboratories., Quallent Pharmaceuticals Health LLC 27241-097, 27241-098, 27241-099 +9
Esomeprazole and NaproxenMakes it Ajanta Pharma USA Inc. 27241-202, 27241-203
FamotidineMakes it Ajanta Pharma USA Inc. 27241-249
Fenofibric AcidMakes it Ajanta Pharma USA Inc. 27241-116, 27241-117, 27241-118 +2
FluphenazineMakes it Ajanta Pharma USA Inc. 27241-252, 27241-253, 27241-254 +1
FluvoxamineMakes it Ajanta Pharma USA Inc. 27241-274, 27241-275
GanciclovirMakes it Ajanta Pharma USA Inc. 27241-158, 27241-159
HaloperidolMakes it Ajanta Pharma USA Inc. 27241-264, 27241-265, 27241-266 +3
IvermectinMakes it Ajanta Pharma USA Inc. 27241-293
MontelukastMakes it Ajanta Pharma USA Inc. 27241-015
NebivololMakes it Ajanta Pharma USA Inc. 27241-179, 27241-180, 27241-181 +1
Oseltamivir AcidMakes it Ajanta Pharma USA Inc. 27241-139
OxcarbazepineMakes it Ajanta Pharma USA Inc. 27241-237, 27241-238, 27241-239
PaliperidoneMakes it Ajanta Pharma USA Inc. 27241-276, 27241-277, 27241-278 +1
PantoprazoleMakes it Ajanta Pharma USA Inc. 27241-256
RanolazineMakes it Ajanta Pharma USA Inc. 27241-125, 27241-126
RisperidoneMakes it Ajanta Pharma USA Inc. 27241-001, 27241-002, 27241-003 +3
SildenafilMakes it Ajanta Pharma USA Inc., Quallent Pharmaceuticals Health LLC 27241-067, 27241-068, 27241-069 +4
SilodosinMakes it Ajanta Pharma USA Inc. 27241-144, 27241-145
TadalafilMakes it Ajanta Pharma USA Inc., Medsource Pharmaceuticals 27241-111, 27241-112, 27241-113 +3
TerazosinMakes it Ajanta Pharma USA Inc. 27241-288, 27241-289, 27241-290 +1
TetrabenazineMakes it Ajanta Pharma USA Inc. 27241-176, 27241-177
TheophyllineMakes it Ajanta Pharma USA Inc. 27241-272, 27241-273
TolterodineMakes it Ajanta Pharma USA Inc. 27241-191, 27241-192
TopiramateMakes it Ajanta Pharma USA Inc. 27241-227, 27241-228, 27241-229 +6
Valproic AcidMakes it Ajanta Pharma USA Inc. 27241-115
VenlafaxineMakes it Ajanta Pharma USA Inc. 27241-221, 27241-222, 27241-223 +1

FDA inspection history

EndedResultProgramProblems noted
Jun 23, 2023No problems foundDrug Quality Assurance—
Jun 22, 2019Problems found, fixed voluntarilyDrug Quality Assurance—
Feb 9, 2018No problems foundDrug Quality Assurance—

Registered with FDA for: manufacture.