Alembic Pharmaceuticals Gets USFDA Nod for Generic Dabigatran Etexilate

Alembic Pharmaceuticals has received approval from the USFDA to market Dabigatran Etexilate Capsules (110 mg) for the prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. This marks the company's 211th ANDA approval. Shares closed 3.17% down at Rs 1,076 on the BSE.

Alembic Pharmaceuticals has successfully secured approval from the US Food and Drug Administration (USFDA) to market its new generic product, Dabigatran Etexilate Capsules (110 mg), the company announced on Tuesday.

The medication is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism post-hip replacement surgery, aligning it as a therapeutic equivalent to Boehringer Ingelheim Pharmaceuticals Inc's Pradaxa Capsules.

This approval adds to Alembic Pharmaceuticals' impressive record, bringing the total number of USFDA approvals to 211. Despite this achievement, the company's shares closed 3.17% down at Rs 1,076 on the Bombay Stock Exchange.