Alembic Pharmaceuticals Limited — Updates, 17-04-2025: Press Release

Alembic Pharmaceuticals has received Final Approval from the USFDA for its Carbamazepine Tablets USP, 200 mg, which are indicated as an anticonvulsant and for treating pain associated with true trigeminal neuralgia. This approval comes under its Abbreviated New Drug Application (ANDA), and the product is considered therapeutically equivalent to Novartis' Tegretol Tablets, 200 mg. The estimated market for Carbamazepine Tablets is approximately USD 32 million for the twelve months ending December 2024, according to IQVIA. With this approval, Alembic has now achieved a total of 222 ANDA approvals, consisting of 196 final and 26 tentative approvals from the USFDA. This milestone could enhance Alembic's market position in the generic pharmaceuticals sector and suggests a positive outlook for the company's revenue growth ahead.