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Cadila gets US FDA plant approval
By siliconindia
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Friday, 16 July 2004, 19:30 IST
AHMEDABAD: The US Food and Drug Administration (USFDA) has approved a formulations plant of Cadila Healthcare Ltd, a mid-sized Indian drug firm, giving a boost to its plans to export generic drugs to the United States.
Cadila got FDA approval for its plant in Moraiya, on the outskirts of Ahmedabad, following a visit by an inspection team from the US authority in May this year, Cadila said in a statement late on Thursday.
Cadila has already filed a dozen abbreviated new drug applications (ANDAs) with the USFDA in the year ended March 2004 and is planning to file up to 18 ANDAs in the year ending March 2005.
"The FDA approval, which covers the plant's tablet and hard gelatin capsule manufacturing facilities, will enable the group to export its products to the US, the world's largest generics market," the statement said.
Cadila plans to launch nine drugs in the United States in 2005 and will launch another three drugs after 2005, the statement said.
Cadila set up a subsidiary in the United States in January this year to tap the fast growing generics market and filed 12 drug master files (DMFs) in the Active Pharmaceutical Ingredients (API) segment.
FDA approval is a prerequisite for any drug company looking to enter the US generic market.