Zydus Cadila files 12 ANDAs in 2002-03

Ahmedabad-based Zydus Cadila Healthcare filed 12 new abbreviated new drug applications (ANDAs) in the financial year 2003-04.

This is the largest number of ANDA filings by an Indian pharma company in the first year of ANDA filing. Zydus started the process with two ANDA filings in November 2003. The company plans to file 16-18 ANDAs in the current financial year.

On the active pharmaceutical ingredients (API) front, the group has so far filed 12 drug master files (DMFs) and plans to file another 16-18 by the year end.

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

Zydus Cadila has already set up Zydus Pharmaceuticals USA Inc to market finished dosage formulations in the US generics market. The total US market for the 12 drugs for which ANDA filings have been made by Zydus is estimated to be $7.4 billion.

The group plans to launch nine of these 12 drugs in the year 2005, the market for which is estimated at $3.5 billion. The remaining three drugs, with an estimated market size of $3.9 billion, will be launched later, company officials said.

"Significant progress has already been made to realise our plans to grow in the generics markets. With a robust pipeline of NDA filings, we will now be best placed to leverage our strengths in generics formulations and effectively participate in the world's largest generics marketplace (US)," said Pankaj Patel, chairman and managing director of Zydus Cadila.

He added that the new initiatives are in line with the company's plans to position itself as a global pharmaceutical player.

Zydus Cadila, which aims to be among the top ten global generics players, will continue to focus on research and development to file more ANDAs and DMFs, a company statement said.

It added that a world-class manufacturing base has buoyed Zydus Cadila's strategic plans to enter the US generics market, where an estimated $40 billion worth of branded drugs will be going off-patent over the next five years.