Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg. These tablets are therapeutically equivalent to Tegretol Tablets, 200 mg, manufactured by Novartis Pharmaceuticals Corporation.
Carbamazepine is primarily used as an anticonvulsant and is also indicated for the treatment of pain associated with true trigeminal neuralgia. The company noted that the approved drug’s estimated market size in the U.S. was around $32 million for the twelve months ending December 2024, according to IQVIA data.
With this approval, Alembic now has a total of 222 ANDA approvals from the USFDA, including 196 final approvals and 26 tentative approvals. This milestone further strengthens its position in the global generics market.
Founded in 1907, Alembic Pharmaceuticals is a vertically integrated R&D-focused company with a global footprint in the manufacture and marketing of generic pharmaceutical products. Its manufacturing and R&D facilities are approved by several global regulatory agencies, including the USFDA.
Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information.
