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Tuesday, June 15, 2010

**[investwise]** Granules India (BSE 532482) Receives USFDA Approval For Metformin

 

Granules India Ltd., a vertically integrated formulation manufacturer, announced the U.S. Food and Drug Administration (U.S. FDA) approved the Company's Abbreviated New Drug Application (ANDA) for Metformin 500mg, 850mg and 1000mg.

The ANDA, which was developed and registered by Granules, is in collaboration with Heritage Pharmaceuticals Inc. Under a previously announced agreement, Heritage retains exclusive sales and marketing rights to the meformin ANDA for several years. Both parties will share net profits from product sales.

"Receiving approval for our first ANDA is an exciting step in our effort of becoming a leading formulation manufacturer. Our U.S. FDA approved formulation facility combined with several pending ANDAs demonstrates Granules is making strong inroads into the formulation segment. We will continue to focus on filing more ANDAs in the future in order to better target the lucrative U.S. market" said Mr. C. Krishna Prasad, Managing Director at Granules India.

About Granules India Ltd.
(BSE: 532482, NSE: GRANULES)

Granules India Ltd. is a vertically integrated formulation manufacturer. The Company is a large-scale manufacturer of Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs), which are distributed in over 50 countries. The Company's operations and logistics expertise along with its scale allow Granules to provide customers high quality products across the pharmaceutical manufacturing value chain at a cost-effective price.

Safe Harbor Statement:

Some forward looking statements on projections, estimates, expectations & outlook are included to enable a better comprehension of the Company prospects. Actual results may, however, differ materially from those stated on account of factors such as changes in government regulations, tax regimes, economic developments within India and the countries within which the Company conducts its business, exchange rate and interest rate movements, impact of competing products and their pricing, product demand and supply constraints.
 
Nothing in this article is, or should be construed as, investment advice.
 
 
 

 
 

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