Alembic Pharmaceuticals Limited

FDA Drug Class III Ongoing

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals,

December 16, 2025 Alembic Pharmaceuticals Limited

FDA Drug Class III Ongoing

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuti

October 10, 2025 Alembic Pharmaceuticals Limited 4,884 30-count bottles units

FDA Drug Class II Ongoing

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., B

July 25, 2025 Alembic Pharmaceuticals Limited 9,492 bottles units

FDA Drug Class II Ongoing

Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceutical

May 9, 2025 Alembic Pharmaceuticals Limited 2,946 500-count bottles units

FDA Drug Class II Ongoing

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Guja

May 7, 2025 Alembic Pharmaceuticals Limited N/A units

FDA Drug Class I Terminated

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceutica

March 17, 2021 Alembic Pharmaceuticals Limited 12288 bottles units

FDA Drug Class II Terminated

Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharm

June 10, 2020 Alembic Pharmaceuticals Limited 19,153 bottles units