Labeler · US market

Advagen Pharma Ltd

Advagen Pharma Ltd is a US drug labeler with US FDA registrations covering 84 drug concepts (84 currently active) across 492 packages. It is currently the only active US supplier of 4 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Advagen Pharma Limited

ACTIVE — US

openFDA · updated weekly

Labeler codes72888

Active drugs84

Registrations207 active / 207

Packages492

Sole supplier of4 drugs

Portfolio84 drugs · US

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

Drug	Type	NDCs	Packages	Status
Carvedilol tablet, film coated	rx	8	28	SUPPLYING
Metoprolol Tartrate tablet	rx	6	18	SUPPLYING
Guanfacine tablet, extended release	rx	4	16	SUPPLYING
Clonazepam tablet	rx	4	16	SUPPLYING
Glipizide tablet	rx	4	15	SUPPLYING
Topiramate capsule	rx	3	15	SUPPLYING
Diclofenac Sodium tablet, delayed release	rx	3	15	SUPPLYING
Tramadol Hydrochloride tablet, coated	rx	4	14	SUPPLYING
Metoprolol Tartrate tablet, film coated	rx	5	13	SUPPLYING
Carbidopa And Levodopa tablet	rx	3	12	SUPPLYING
Desvenlafaxine tablet, extended release	rx	3	12	SUPPLYING
Baclofen tablet	rx	4	12	SUPPLYING
Buspirone Hydrochloride tablet	rx	5	11	SUPPLYING
Amitriptyline Hydrochloride tablet, film coated	rx	6	10	SUPPLYING
Sildenafil tablet, film coated	rx	4	10	SUPPLYING
Isosorbide Dinitrate tablet	rx	5	10	SUPPLYING
Clonazepam tablet, orally disintegrating	rx	5	10	SUPPLYING
Lamotrigine tablet	rx	4	10	SUPPLYING
Oxcarbazepine tablet, film coated	rx	3	9	SUPPLYING
Bisoprolol Fumarate tablet, film coated	rx	3	9	SUPPLYING
Dicyclomine Hydrochloride tablet	rx	2	9	SUPPLYING
Primidone tablet	rx	3	8	SUPPLYING
Triamterene And Hydrochlorothiazide tablet	rx	2	8	SUPPLYING
Gabapentin tablet	rx	2	8	SUPPLYING
Guanfacine tablet	rx	2	8	SUPPLYING
Nicotine Polacrilex lozenge	otc	2	8	SUPPLYING
Carbidopa And Levodopa tablet, extended release	rx	2	8	SUPPLYING
Labetalol Hydrochloride tablet, film coated	rx	4	8	SUPPLYING
Dexamethasone tablet	rx	7	7	SUPPLYING
Cyclobenzaprine Hydrochloride tablet, film coated	rx	3	7	SUPPLYING
Potassium Chloride tablet, film coated, extended release	rx	3	7	SUPPLYING
Diclofenac Potassium tablet, coated	rx	2	7	SUPPLYING
Potassium Chloride tablet, extended release	rx	3	6	SUPPLYING
Oxcarbazepine tablet	rx	3	6	SUPPLYING
Oxybutynin Chloride tablet, extended release	rx	3	6	SUPPLYING
Ivermectin tablet	rx	2	6	SUPPLYING
Venlafaxine Hydrochloride capsule, extended release	rx	3	6	SUPPLYING
Amiodarone Hydrochloride tablet	rx	3	5	SUPPLYING
Buprenorphine Hydrochloride tablet	rx	2	4	SUPPLYING
Tizanidine Hydrochloride capsule	rx	4	4	SUPPLYING

Showing 40 of 84 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 codes72888
Filing names2
Drugs (active)84
Drugs (all time)84
US registrations207
Packages492

Recent events

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

Aug 24, 2024
RECALLRecall (Class III): AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ,…
Apr 26, 2024
RECALLRecall (Class II): traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plai…
Mar 10, 2023
SHORTAGEDrug shortage: Clonazepam Tablet (Rubicon Research Private Limited)

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 (see “Also files as” above); figures cover the entity across all its filing names.