Ranbaxy Laboratories Ltd (Ranbaxy) has informed us that the Medicines and Healthcare products Regulatory Agency (MHRA) of UK, and the Therapeutic Goods Administration (TGA), Department of Health and Ageing of the Australian Government, have issued Good Manufacturing Practice (GMP) certificates for its manufacturing site at Paonta Sahib (India), following a joint audit conducted in October 2008. The MHRA approval will not only cover product filings for the UK hut will also apply to product filings for the entire European Union.
Both authorities had inspected this facility in 2006 and had found it to be compliant with the respective principles and guidelines of GMP. GMP certificates valid up to 2 years were issued.
Subsequent to the routine re-audit in November 2008 conducted by these authorities, GMP certification has been extended for a further 3 years by the MHRA and for 2 years by the TGA.
Ranbaxy remains committed to providing high quality generic medicines at affordable prices to its customers and patients in Europe, Australia and the entire global marketplace.
Ponta Sahib facility is the same one where US FDA has started invstigation. After clearance from the UK, Australia and the EU, we feel that US FDA ban on Ponta Sahib products maybe part of the larger corporate espionage as American drug maker Pfizer couldn’t bid for Ranbaxy and is likely to train the Global battle for generics.