Alembic Pharmaceuticals Ltd News Today

The approved product is the generic equivalent of Tegretol Tablets 200 mg, which was initially developed by Novartis Pharmaceuticals Corporation.

This approval bolsters Alembic's portfolio in the United States market and reinforces its presence in injectable segment 

Following an inspection carried out from Nov 14-22 2024, the facility was cited as being ‘VAI’ (Voluntary Action Indicated).

EBITDA margin came in at 15.4% in the quarter under review as compared to 16.30% in the previous corresponding period.

The authorised ANDA is a therapeutic equivalent of the reference-listed drug (RLD), Corlanor tablets, in the same 5 mg and 7.5 mg dosages.

These medications are also used to treat chronic stable angina and angina induced by coronary artery spasm.

Alembic Pharmaceuticals continues to grow its footprint in the US, with this approval contributing to its robust portfolio of generic medications.

The business stated that the authorised ANDA is therapeutically similar to the reference-listed drug product (RLD) Lastacaft Solution.

The approved Lamotrigine Extended-Release tablets are therapeutic equivalents of GlaxoSmithKline's Lamictal XR, with strengths of 200 mg, 250 mg, and 300 mg.

Alembic Pharmaceuticals has got the final approval from USFDA for Dabigatran Etexilate Capsules, 110 mg.