Ipca gets US FDA nod for Propranolol

Ipca gets US FDA nod for Propranolol


Mumbai: Drug firm Ipca Laboratories Ltd today said it has entered into an strategic alliance with US based Heritage Pharmaceuticals Inc. to manufacture and market Propranolol HCI Oral Tablets, used for cardiovascular treatment.

Under the alliance, Ipca received approval from U.S. Food and Drugs Administration to manufacture and market the medicine in 10, 20, 40, 60 and 80 mg strength in the US market, it said in a filing to the Bombay Stock Exchange.

Ipca would manufacture and Heritage would commercialise this product in the U.S. market. Heritage would utilise its distribution network to market this formulation in the US healthcare system using Ipca’s DMF approved Active Pharmaceutical ingredient (API).

Propranolol Tablets has multiple cardiovascular related usages, including the treatment of hypertension, severe chest pain and abnormal rhythm of the heart.

Earlier this year, in June, Ipca received the USFDA approval to manufacture Propranolol HCI Oral Tablets for the US market and it was the first product approval received by Ipca for manufacturing a formulation.

At the same time, under the strategic alliance with Ranbaxy, Ipca received another USFDA approval to manufacture and market Metoclopramide Tablets.

Shares of the company were trading at Rs495, down 2.82% on the BSE.