Zydus unit gets USFDA nod

Ahmedabad-based Zydus Cadila Healthcare has secured the US Food and Drug Administration's (USFDA) approval for its formulations manufacturing plant at Moraiya.

The USFDA had inspected Zydus Cadila's formulations facility in May this year.

The company said here on Thursday that the USFDA approval will boost the group's plans to hasten the process of launching its products in the US, the world's largest generics market.

The USFDA approval, which will cover the tablet and hard gelatin capsule manufacturing facilities, will enable Zydus to enhance its product exports to the US. Zydus has already set up a US subsidiary "" Zydus Pharmaceuticals USA Inc "" and has filed 12 abbreviated new drug applications (ANDAs) with the USFDA.

Zydus is the second pharmaceutical company of Gujarat that has secured a USFDA approval for its formulations manufacturing facility.

J B Chemicals and Pharmaceuticals was the first company in the state to secure a USFDA approval for its formulations manufacturing in January this year. However, all pharmaceutical majors of Gujarat have USFDA approval for their bulk drug manufacturing facilities.

Zydus Pharmaceuticals USA Inc will be headed by Joseph Renner, as the chief executive officer of the company. Renner was earlier the chief operating officer of Sandoz, US, previously Geneva Pharmaceuticals.

Of Zydus' 12 ANDAs which have been filed for finished dosage formulations, Zydus aims to launch nine drugs in the US in 2005.

The market for these nine drugs is estimated to be $3.5 billion. The remaining three ANDAs, which will be launched in the US after 2005, have an estimated market of $3.9 billion.

The formulations plant at Moraiya is spread over 40 acres with a built-up area of 53,000 sq metre. The plant manufactures tablets, capsules, liquids and injectables.