UK and Australia clear Ranbaxy’s Paonta Sahib plant
Regulators in the UK and Australia have issued GMP certificates for Ranbaxy Laboratories' Paonta Sahib plant after a joint inspection deemed manufacturing practices were up to code.
The accreditation, which followed a routine re-audit in November, is the first positive news for the plant since the US Food and Drug Administration (FDA) imposed an import ban and halted its review of all drugs made there earlier this year.
While the Therapeutic Goods Administration (TGA) approval is limited to the sale of drugs in Australia, clearance from the Medicines and Healthcare products Regulatory agency (MHRA) enables Ranbaxy to sell medicines in both the UK and Europe under the regions mutual recognition procedure.
