Zydus Cadila's Moraiya plant for formulations manufacturing has been approved by US FDA. US FDA had inspected the plant in May this year.
The US FDA approval, which covers the plant's tablet and hard gelatin capsule manufacturing facilities, will enable the group to export its products to the USA, the world's largest generics market. The group has already set up a subsidiary - Zydus Pharmaceuticals USA Inc, and has filed 12 ANDAs with the USFDA, a company release said.
The Moraiya plant which is the largest plant of its kind at a single location in India has already been approved by the MHRA of UK, MCC of South Africa, WHO, BFAD of Philippines and the National Drug Authorities of several other countries. The plant, commissioned in 1999 manufactured solid dosage forms - comprising tablets, hard gel capsules and soft gel capsules, metered dose inhalers, dry powder inhalers, transdermal patches, ampoules, vials and lyophilized vials, vaccines, oncology formulations and liquids.
Out of the total 12 ANDAs filed for finished dosage formulations, the group plans to launch 9 drugs in the USA in 2005, the market for which is estimated at US$ 3.5 bn. The remaining three drugs with an estimated market size of US$ 3.9 bn will be launched after 2005, the release said.