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Zydus Cadila files 12 ANDAs in FY-04

April 01, 2004 18:47 IST

Ahmedabad-based Zydus Cadila group has filed 12 Abbreviated New Drug Applications in fiscal 2003-04 even as the company has set a target to file 16-18 ANDAs in the current financial year.

The group started the process with two ANDAs in November 2003 and ended the year with 12, which have an estimated market of $7.4 billion in the US, the entity said in a release on Thursday.

The group plans to launch nine of these drugs from July 2005, the market for which is estimated at $3.5 billion. The remaining three drugs with an estimated market size of $3.9 billion would be launched later, it said.

On the Active Pharmaceutical Ingredients front, the group has filed 12 Drug Master Files so far and plans to file 16-18 DMFs more in the coming year, it said.

ANDA approvals for generic formulations and DMF listings for APIs are a prerequisite for any pharma company looking to enter the US generic market.

Zydus Cadila has already set up Zydus Pharmaceuticals USA Inc, to market finished dosage formulations to the US generic market place.

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