Alembic Pharma Receives USFDA Nod for generic hypertension treatment Capsules

Alembic Pharmaceuticals Ltd announced that it has obtained approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules, which are used for treating hypertension. The pharmaceutical firm stated that the USFDA has approved the abbreviated new drug application (ANDA) for Diltiazem Hydrochloride extended-release capsules in 120 mg, 180 mg, and 240 mg strengths.

These have the same therapeutic effect as the reference drug Dilacor XR Extended-Release Capsules in 120 mg, 180 mg, and 240 mg by Allergan Sales LLC, it stated.

Diltiazem Hydrochloride extended-release capsules are prescribed for managing hypertension. The medication can be taken by itself or together with other drugs that treat high blood pressure, like diuretics. The company also noted that it can be used to treat chronic stable angina. Based on IQVIA data, Alembic Pharma reported that Diltiazem Hydrochloride extended-release capsules in three different strengths have a projected market value of $28.2 million for the year ending June 2024.

The pharmaceutical company is engaged in the production and promotion of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. Based in Vadodara, Gujarat, a third of our revenue of more than $600 million comes from the Indian market. The Panelav facility produces active pharmaceutical ingredients (APIs) and formulations, while the Sikkim facility manufactures formulations for both domestic and international markets.