Wednesday, June 4, 2008

Ipca receives US FDA nod for propranolol tablets

Ipca Laboratories has received approval from US Food and Drugs Administration to manufacture propranolol hydrochloride tablets USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg for the US market.

Total annual market sales for propranolol hydrochloride tablets in US were US$ 24.1 millions (IMS-MAT: December 2007).

According to a company release, this is the first product approval received by lpca for a product manufactured from its Piparia (Silvassa) formulations manufacturing unit after the said unit's pre approval inspection recently by US FDA.

lpca will manufacture this formulation for the US healthcare system from its Piparia (Silvassa) formulations manufacturing unit using lpca's own DMF approved Active Pharmaceutical ingredient (API) - propranolol hydrochloride.

Ipca is a fully integrated pharmaceutical company engaged in the manufacturing and marketing of a range of pharmaceuticals world over. Ipcas exports to over 110 countries across the globe contributed about 50 per cent of the company's income of Rs. 1085 crore in the financial year 2007-08.

source:www.pharmabiz.com

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