Cadila Pharma to file first ANDA in US in August, set to tap generic market potential

The Ahmedabad-based Cadila Pharmaceuticals, one of the largest privately held pharmaceutical companies in India, is planning to commence filing Abbreviated New Drug Applications (ANDAs) and to increase the number of Drug Master Filings (DMFs) in US as a strategy to increase its market presence in the regulated markets.

The company, which has its market presence in more than 50 countries, is planning to file the first ANDA in US in August, 2009, according to I A Modi, chairman, Cadila Pharmaceuticals Ltd. The company has identified a partner in US and will launch a joint venture firm to look after the US business. He added that the company is ready with three products for generic filings in US and plans are to file six to eight ANDAs in every year from now onwards.

"We have plans to enter into the ANDA filing mode to grab the US generic market. We have been analysing the situation in US and are ready to go ahead with the plans," said Modi. 

Cadila will have 50 per cent stake in the joint venture company, which is to be named as Modaware, whereas the US-based partner will hold the rest of the 50 per cent and will carry out the ANDA filing and marketing projects for the former. However, he refused to reveal the identity of the partner company and the therapeutic area in which the first ANDA would be filed.

The company, which currently has 25 DMFs in its kitty, is also planning to increase the number of drug master filings with the US Food and Drug Administration (FDA). Plans are to file four to five DMFs with the US regulator in every year, said Modi. With the filing of ANDAs and more DMFs, the company will be joining the Indian generic companies' bandwagon of exploring opportunities in the growing US generic market.

Cadila Pharma has also recently entered into a pact with the US based Novavax, Inc, to develop, manufacture and market the latter's products in India. The company has announced floating of its new biotech firm, CPL Biologicals Pvt Ltd, to conduct contract research and manufacturing operations for Novavax in India.

The company, earlier, has received five Investigation New Drug (IND) approvals from the US FDA for its products under development including a tuberculosis (TB) drug candidate Cadi 05, addressing Multi Drug Resistant (MDR) TB and another micro bacterium candidate - MWB - to support various types of Cancer patients. The company is expecting these two drugs to be ready for launch in the end of 2011, informed Modi.


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