IHS Chemical Week

EnviroTech :: Regulatory

Ranbaxy’s Controversial India Plant Gets Australian, U.K. Regulatory Approvals

2:06 AM MDT | March 23, 2009 | Deepti Ramesh

Ranbaxy Laboratories (Gurgaon, India) says that the Medicines and Healthcare products Regulatory Agency (MHRA; London) of the U.K., and the Therapeutic Goods Administration (TGA; Canberra), Australia’s drug regulatory body, have issued good manufacturing practice (GMP) certificates for Ranbaxy’s Paonta Sahib, India manufacturing facility, following a joint audit conducted last October. Ranbaxy says that the MHRA approval will cover product filings for the U.K. and also apply to product filings for the entire European Union. The U.S. FDA said last...

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