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Ind-Swift Laboratories Limited undergoes successful USFDA audit


Ind-Swift Laboratories Ltd. has successfully completed USFDA inspection for  Clarithromycin, Active Pharmaceutical Ingredient (API) manufacturing facility. Ind-Swift Laboratories Inc. USA, a wholly owned subsidiary of Ind-Swift Laboratories 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 American market. Ind Swift Laboratories 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.

Ind-Swift 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.

Ind-Swift Laboratories 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. The facility has already received the COS and TGA certifications.

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. Ind-Swift is one of the largest manufacturer of Clarithromycin after the innovator.