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Ind Swift Laboratories undergoes successful USFDA audit



Posted On : 2007-02-08 03:32:24( TIMEZONE : IST )

Ind Swift Laboratories undergoes successful USFDA audit

Ind Swift Laboratories Ltd has announced that the Company has successfully completed USFDA inspection for Clarithromycin, Active Pharmaceutical Ingredient (API) manufacturing facility. Ind-Swift Laboratories Inc USA (ISL INC.), a wholly owned subsidiary of the Company was instrumental in achieving this milestone, said N R Munjal, Managing Director.

This would enable us to roll out our API's in the North Amercian market. ISL Inc. has partnered with top US generic Companies for generic pharmaceutical business. We are also working on alliances with biotechnology Companies in North America which will fuel our long term growth strategy said Vikas Narendra, President Ind-Swift Laboratories Inc.

The Company has already filed 10 Drug Master Files (DMF's) and plans to file a significant number of DMF's with USFDA during next financial year. This will pave way for the Company to enter the US market, which is biggest generic drugs market in the World.

The Company has a significant presence in more than 45 countries, in addition to a strong position in the domestic market. Its research and development centre employs over 150 scientists.

Clarithromycin is a Macrolide Antibiotic Molecule used in the treatment of the lower respiratory tract infections. The Macrolides have a World Market Size of US$ 1.3 bn. The Company is one of the largest manufacturer of Clarithromycin after the innovator.

The facility has already received the COS and TGA certifications. The Company is also at an advanced stage of launching its drugs in the Japanese Markets.

Source : Equity Bulls

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