Ind Swift Laboratories Ltd. said that the US FDA has successfully completed inspection of active pharmaceutical ingredient (API) manufacturing facility for clarithromycin.
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.
The successful inspection of clarithromycin will enable the company to roll out its API's in the North American market. The company said ISL Inc. has partnered with top US generic companies for generic pharmaceutical business.
According to Vikas Narendra, president, Ind-Swift Laboratories Inc., the company is working on alliances with biotechnology companies in North America to fuel its long-term growth strategy.
The company revealed that it has already filed 10 Drug Master Files (DMF's) and plans to file a significant number of DMF's with the US FDA 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.
Clarithromycin is a macrolide antibiotic molecule used in the treatment of the lower respiratory tract infections. The macrolides have a world market of US$ 1.3 billion. The company is one of the largest manufacturers of clarithromycin after the innovator, a press release stated.
The facility had already received the COS and TGA certifications. The company is also at an advanced stage of launching its drugs in the Japanese markets.