Press Statement
Princeton, New Jersey - February 26, 2009:
Ranbaxy has just received a letter and information indicating
that all pending and approved ANDAs from Ranbaxy's Paonta
Sahib facility have been added to a list maintained
under a policy entitled "Application Integrity
Policy" or "AIP". Ranbaxy will analyze
the letter and other information fully and respond appropriately
in a timely manner.
The FDA has said it has no evidence the drugs on the
market are substandard and also that they comply with
specifications upon testing.
No products from Ranbaxy’s other manufacturing
facilities are included in the AIP.
Ranbaxy will continue to co-operate with the USFDA.
Further, no effort or action will be spared to timely
protect key ANDAs from Paonta Sahib, which include some
First to File applications.
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 across geographies. Ranbaxy’s
continued focus on R&D has resulted in several approvals
in developed markets and significant 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 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,
ground operations in 49 countries and manufacturing
operations in 11 countries.
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