Cadila gets USFDA nod for 2 drugs

Company plans to launch the drugs by end-May

The Ahmedabad-based Zydus Cadila Healthcare Ltd has received the United States Food and Drug Association's (USFDA) approval for two drugs.

Zydus Cadila received the approval from the USFDA to market the anti-hypertensive drug, Atenolol, and an anti-infective drug, Clindamycin on Monday and Tuesday. The company is planning to launch both the drugs by the end of May.

The company is at present strengthening its position in the US market through its wholly owned subsidiary, Zydus Pharmaceuticals (USA) Inc.

Pankaj R Patel, chairman and managing director of Zydus Cadila, said, "Apart from Atenolol and Clindamycin, the group expects to launch six more drugs this year, subject to approvals of the regulatory body. We are set to make an entry into the US generic market."

A company source said the approval for Atenolol and Clindamycin was the latest in a series of developments that mark Zydus Cadila's foray into the US generic markets.

The total US market for this drug is estimated at $87 million, industry estimates reveal.

The process, which started with the setting up of Zydus Pharmaceuticals (USA) Inc. early 2004, gathered momentum with the filing of 12 abbreviated new drug applications (ANDAs) by the end of financial year 2003-04.

This was the largest number of ANDAs filed by an Indian company in one year. With a focus on building a robust pipeline of ANDA filings, the group is likely to end the current financial year with 14 filings, taking the total number of filings to 26.

To strengthen its existence in the booming US pharmaceutical market, Zydus hired the chief operating officer of Sandoz, Joseph Renner to head its subsidiary, Zydus Pharmaceuticals.

Renner believes that with the USFDA approval for the drugs and subsequent launches, Zydus would be leveraging in the US among many significant players in that market.

Deciding to go in for a two-pronged effort for the US, the group set up Zydus Healthcare LLC to market Active Pharmaceutical Ingredients and Zydus Pharmaceuticals (US) to market formulation generics.

In the Latin American market, which is valued at Rs 5,000 crore, Zydus has set up base in Brazil with its wholly owned subsidiary Brasil Healthcare Limitada.

In the third quarter of the current financial year, Zydus Cadila, the flagship company of the Ahmedabad-based Zydus Group, has reported a 29 percent surge in its net profit to Rs 39.5 crore, up from Rs 30.6 crore reported in the corresponding period of the last financial year.

Net sales for the period was up by 7.9 per cent which stood at Rs 278 crore as against Rs 258 crore in the previous year.