Ranbaxy Laboratories’ Paonta Sahib factory today (24th March) won good manufacturing certification from British and Australian drug regulators. Ranbaxy said  that, UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and Australia's Therapeutic Goods Administration (TGA) renewed the good manufacturing practice (GMP) certificates they had earlier issued to the Paonta Sahib facility.

 

This development will help Ranbaxy to supply medicines from the facility to the entire European Union and Australia. USA and Europe are the two biggest markets of Ranbaxy. In 2008 alone, nearly $300 million of the company’s sales came from 23 EU member countries. Earlier, both these authorities had inspected the Paonta Sahib in 2006. They found it to be in compliance with the respective principles and guidelines of GMP.

 

This approval comes almost a month after the US Food and Drug Administration (USFDA) charged the company with falsifying data from the factory. Following that, doubts had arisen whether other regulators would also review their approvals to the facility. However, the British and Australian regulators’ decisions have enabled Ranbaxy to allay such fears partially. The certification has been extended for a further three years by the MHRA and for two years by the TGA.