New Delhi: Drug firm Ranbaxy Laboratories Ltd today said it has received good manufacturing practice certificate from UK and Australian health regulators for its facility at Paonta Sahib in Himachal Pradesh.
“Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and the Therapeutic Goods Administration (TGA), Department of Health and Ageing of the Australian Government have issued Good Manufacturing Practice (GMP) certificates for the company’s manufacturing site at Paonta Sahib, following a joint audit conducted in October 2008,” Ranbaxy said in a statement.
The MHRA approval will not only cover product filings for the UK but will also apply to product filings for the entire European Union, it added.
Both authorities had earlier inspected this facility in 2006 and found it to be compliant with the respective principles and guidelines of GMP. After which the facility was awarded with GMP certificates that were valid for two years.
Both authorities again re-audited the facility in November 2008 after which the GMP certification has been extended for another three years by the MHRA and for two years by the TGA, the Gurgaon-based firm said.
However, Paonta Sahib facility of the company was blacklisted by the US Food and Drug Administration (FDA) for falsifying data in their drug applications.