Mumbai:
Ipca Laboratories which has formed a strategic alliance
with Ranbaxy Laboratories'' US subsidiary Ranbaxy Pharmaceuticals
Inc., has received approval from US Food and Drugs Administration
to manufacture and market Metformin Hydrochloride USP
tablets 500mg, 850mg and 1000mg in the US market.
Under
the strategic alliance, Ohm Laboratories, Inc., a wholly
owned subsidiary of RLL has now received approval from
US Food and Drugs Administration to manufacture and market
Metformin Hydrochloride USP tablets 500mg, 850mg and 1000mg
in the US market.
Metformin
HCL tablets has total annual market sales of $ 379 millions
in the US, according IMS-MAT March 2007 data..
This
is the fifth such product approval received under the
alliance from US FDA, Ipca said in a filing with the Bombay
Stock Exchange (BSE).
The
company will manufacture this formulation utilising its
facilities in India. It is setting up a new formulations
manufacturing facility meeting US regulatory requirements
at SEZ Indore. The company is already holding US DMF of
Metformin HCL.
Ranbaxy
will commercialise this product in the US market utilising
its established marketing expertise and distribution network.
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