Alembic Pharmaceuticals Ltd announced on Monday that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its generic Diltiazem Hydrochloride extended-release capsules, which are used to treat hypertension.
The USFDA approved the abbreviated new drug application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules in five strengths: 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. These capsules can be used alone or in combination with other medications to manage high blood pressure.
In addition to hypertension, Diltiazem Hydrochloride is also indicated for managing chronic stable angina and angina caused by coronary artery spasms. According to IQVIA data, the estimated market size for these capsules is approximately $105.3 million for the year ending June 2024.
This approval adds to Alembic’s growing portfolio of generic medications in the U.S. market. The company now holds a total of 218 ANDA approvals from the USFDA, including 191 final approvals and 27 tentative approvals.
Alembic Pharmaceuticals, established in 1907 and based in Vadodara, operates advanced research and manufacturing facilities that meet the standards of regulatory authorities in several developed countries. The company also maintains a strong presence in India’s branded generics market, supported by a sales team of over 5,200 representatives marketing its products to healthcare providers.
Related topics:
- New Outpatient Payments Approved for Renal Denervation Systems by Recor Medical & Medtronic
- UT Researcher Investigates Glyphosate’s Connection to High Blood Pressure
- Hypertension Is Leading Cardiovascular Comorbidity in Dialysis Patients, Study Finds