Ind Swift Laboratories Ltd has obtained the ‘therapeutic goods administration’ (TGA) certification from the Australian Commonwealth department of health and ageing for its manufacturing facility for 'Clarithromycin' which has a market share of $1.18 billion. The company is one of the largest manufacturer of Clarithromycin in the world and enjoys 30 per cent to 33 per cent of the global capacity for this drug.

The Australian Commonwealth department of health and ageing has recommended that "the company complies with the requirement of the Australian code of good manufacturing practice for medicinal products, for the range of products to be supplied to Australia.

The manufacturing facilities are situated at Derabassi in Punjab, which has eight dedicated blocks to manufacture APIs and advanced intermediates for regulated markets and another at Jammu, which is primarily focused on manufacturing of API for the domestic markets. It recently launched four new APIs — Letrozole (aromtase inhibitor), quetiapine fumerate (anti-psychotic), aripiprazole (anti-pshycotic) and ropinirole (Parkinson Disease).

"The TGA certification will leverage the company’s intrinsic potential and place it at par with the other leading players in the industry," said V K Mehta joint managing director.

Ind Swift Laboratories’ facilities are certified by the WHO and the Iranian government since it has a JV agreement with an Iranian company for manufacturing and marketing them in the Middle East and parts of Europe.. The company says that it has filed seven DMFs in the US and around 50 DMFs in Europe and that it has also filed 13 patents for non-infringing processes for its products in the US and India.

"We plan to receive 60 per cent of the exports revenues from the regulated markets by 2008 for which we will be filing four or five DMFs every year in the US.