Ranbaxy Laboratories Ltd said on Monday that drug regulators of the UK and Australia have approved its Paonta Sahib manufacturing facility in Himachal Pradesh. Drugs made in the plant had been barred by the US Food and Drug Administration in February on the ground that they may not be compliant with FDA standards.
Ranbaxy, in which Japan's Daiichi Sankyo holds a majority stake, said the UK's Medicines and Healthcare Products Regulatory Agency and Australia's Therapeutic Goods Administration had issued ''good manufacturing practice'' (GMP) certificates for the facility after a joint audit conducted late last year.
The MHRA approval will not only cover product filings for the UK but will also apply to product filings for the entire European Union, the company added. However, it remained silent on US approval. It was the American FDA that had first questioned the practices at the Paonta Sahib plant. (See: Ranbaxy plant in India falsified data: US FDA and Daiichi, Ranbaxy form team to face FDA charges)
According to the company, ''Subsequent to the routine re-audit in November 2008 conducted by these authorities (UK an Australian), the GMP certification has been extended for another three years by the MHRA and for two years by the TGA,'' the drug-maker said.
Ranbaxy's shares rose after the company's announcement.