Alembic Pharmaceuticals Limited announced today it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of Diltiazem Hydrochloride Extended-Release Capsules. The approval covers five dosage strengths: 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.
The shares of Alembic Pharmaceuticals Limited were trading at ₹140.40 up by ₹8.41 or 6.37 per cent on the NSE today at 11.50 am.
The approved medication, therapeutically equivalent to Bausch Health’s Cardizem CD Extended-Release Capsules, is used to treat hypertension and manage chronic stable angina. According to IQVIA data, the approved drug has an estimated market size of US$105.3 million for the twelve months ending June 2024.
The Vadodara-based pharmaceutical company now holds 218 ANDA approvals from the USFDAincluding 191 final approvals and 27 tentative approvals. This latest approval adds to Alembic’s growing portfolio of generic medications in the US market.
Alembic Pharmaceuticals, established in 1907, operates state-of-the-art research and manufacturing facilities approved by regulatory authorities of several developed countries. The company maintains a strong presence in India’s branded generics market with a field force of over 5,200 representatives marketing its products to healthcare providers.