Labeler · US market

Ajanta Pharma USA Inc.

Ajanta Pharma USA Inc. is a US drug labeler with US FDA registrations covering 69 drug concepts (69 currently active) across 262 packages. It is currently the only active US supplier of 4 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes27241

Active drugs69

Registrations168 active / 168

Packages262

Sole supplier of4 drugs

Portfolio69 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Topiramate capsule, extended release	rx	9	13	SUPPLYING
Aripiprazole tablet	rx	6	12	SUPPLYING
Risperidone tablet	rx	6	12	SUPPLYING
Duloxetine capsule, delayed release	rx	4	11	SUPPLYING
Doxepin Hydrochloride capsule	rx	5	10	SUPPLYING
Tadalafil tablet	rx	5	9	SUPPLYING
Venlafaxine tablet, extended release	rx	4	8	SUPPLYING
Terazosin capsule	rx	4	8	SUPPLYING
Sildenafil tablet, film coated	rx	3	8	SUPPLYING
Amlodipine Besylate And Olmesartan Medoxomil tablet	rx	4	8	SUPPLYING
Captopril tablet	rx	4	7	SUPPLYING
Lansoprazole capsule, delayed release	rx	2	7	SUPPLYING
Tolterodine Tartrate capsule, extended release	rx	2	6	SUPPLYING
Brexpiprazole tablet	rx	6	6	SUPPLYING
Oxybutynin Chloride tablet, extended release	rx	3	6	SUPPLYING
Fenofibrate capsule	rx	3	6	SUPPLYING
Clomipramine Hydrochloride capsule	rx	3	6	SUPPLYING
Ranitidine capsule	rx	2	4	SUPPLYING
Omeprazole And Sodium Bicarbonate for suspension	rx	2	4	SUPPLYING
Lamotrigine tablet, orally disintegrating	rx	4	4	SUPPLYING
Ranolazine tablet, extended release	rx	2	4	SUPPLYING
Paliperidone tablet, extended release	rx	4	4	SUPPLYING
Memantine Hydrochloride tablet	rx	2	4	SUPPLYING
Metformin Hydrochloride tablet, extended release	rx	4	4	SUPPLYING
Fluphenazine Hydrochloride tablet	rx	4	4	SUPPLYING
Fenofibrate tablet	rx	2	4	SUPPLYING
Solifenacin Succinate tablet, film coated	rx	2	4	SUPPLYING
Varenicline Tartrate tablet, film coated	rx	2	3	SUPPLYING
Carbamazepine tablet, extended release	rx	3	3	SUPPLYING
Oxcarbazepine tablet, extended release	rx	3	3	SUPPLYING
Silodosin capsule	rx	2	3	SUPPLYING
Doxycycline Hyclate capsule	rx	2	3	SUPPLYING
Divalproex Sodium capsule, coated pellets	rx	1	3	SUPPLYING
Montelukast Sodium tablet, coated	rx	1	3	SUPPLYING
Almotriptan tablet, film coated	rx	2	2	SUPPLYING
Acetazolamide tablet	rx	2	2	SUPPLYING
Zolmitriptan tablet	rx	2	2	SUPPLYING
Chlorthalidone tablet	rx	2	2	SUPPLYING
Guanfacine tablet	rx	2	2	SUPPLYING
Theophylline tablet, extended release	rx	2	2	SUPPLYING

Showing 40 of 69 drugs by package count.

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes27241
Filing names1
Drugs (active)69
Drugs (all time)69
US registrations168
Packages262

Recent events

Shortages, recalls, and registration changes across all filing names.

May 28, 2026
RECALLRecall (Class II): Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Aj…
May 27, 2026
RECALLRecall (Class II): Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made …
Apr 29, 2026
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ …
Apr 29, 2026
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ …
Apr 29, 2026
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.