Ranbaxy's Paonta Sahib Plant Receives MHRA, UK And TGA, Australia Approvals For GMP Compliance

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Mar 2009 - 3:00 PDT

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Ranbaxy Laboratories Limited (Ranbaxy) announced 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 but 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.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research-based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients globally. Ranbaxy's continued focus on R&D has resulted in a significant number of approvals in developed markets and progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of novel products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances. To date, it has ground operations in 49 countries and manufacturing operations in 11 countries.

Ranbaxy Laboratories
http://www.ranbaxy.com

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