June 4, 2008:     Ipca receive U.S. FDA Approval For Propranolol Hydrochloride Tablets

Ipca Laboratories Limited (Ipca) has received approval from U.S. 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 U.S. were US $ 24.1 millions (IMS-MAT : December 2007).

This is the first product approval received by Ipca for a product manufactured from its Piparia (Silvassa) formulations manufacturing unit after the said unit's pre-approval inspection recently by US FDA.

Ipca will manufacture this formulation for the US healthcare system from its Piparia (Silvassa) formulations manufacturing unit using Ipca's own DMF approved Active Pharmaceutical Ingredient (API) - Propranolol Hydrochloride.

Ipca has set up a new formulations manufacturing facility meeting U.S. regulatory requirements at SEZ Indore. The commercial production from this facility is expected to commence from the 2nd half of the financial year 2008 - 09.

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

Premchand Godha
Managing Director

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