India’s Ranbaxy Laboratories says that regulators in the UK and Australia have given a clean bill of health to its facility at Paonta Sahib, the company’s manufacturing plant which has been accused of falsifying data by the US Food and Drug Administration.
The Gurgaon-based firm notes the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Therapeutic Goods Administration, Department of Health and Ageing of the Australian Government, have issued Good Manufacturing Practice certificates for the facility. The thumbs-up follows a joint audit conducted in October last year and Ranbaxy added that the MHRA approval will also apply to product filings for the entire European Union.
Both authorities inspected the Paonta Sahib facility in 2006 and had found it to be compliant “with the respective principles and guidelines of GMP”, Ranbaxy said. A routine re-audit last November means that GMP certification has been extended for a further three years by the MHRA and for two years by the TGA.
So good news for Ranbaxy, especially given the FDA’s decision last month to suspend reviews of any products whose file contains data from the Paonta Sahib facility. The agency said that its investigations “revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications”.
In September last year, the FDA issued two warning letters and instituted an ‘import alert’ barring the entry of all finished drug products and active pharmaceutical ingredients from Paonta Sahib, as well as from Ranbaxy’s Dewas and Batamandi facilities. This resulted in a ban stopping the import of 30 Ranbaxy generics into the USA.
Dr Reddy’s pulls out of small markets
Staying in India and Dr Reddy’s Laboratories has announced that it is pulling out of 25 of the 40 markets where it sells generics.
The company is to exit some of the “very small distributor-driven markets” it has been operating in but they make “an overall contribution of less than 1% to the topline”. In addition to the USA, India, Russia & CIS and Germany, which contribute approximately 90% of Dr Reddy’s global generics revenues, the firm will continue operations in 10-15 markets where finished dosages sales are growing significantly.
Chief operating officer Satish Reddy said this “market prioritisation exercise would lead to redeployment of resources within the organisation”. He added that the company will however continue to “scan opportunities” in international markets.
