GURGAON, India, Feb. 25 /PRNewswire/ -- 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.
Company Contacts for Media: India Contacts: Ramesh L. Adige President - Corporate Affairs and Global Corporate Communications Ranbaxy Laboratories Ltd. Plot 90, Sector 32, Gurgaon Haryana122001, India Tel: +91-124-4135000 e-mail: email@example.com or Raghu Kochar Director - Corporate Communications Ranbaxy Laboratories Ltd. Plot 90, Sector 32, Gurgaon Haryana122001, India Tel: +91-124-4135141 / Mob: 9811617256 e-mail: firstname.lastname@example.org or Krishnan Ramalingam Sr. Manager - Corporate Communications Ranbaxy Laboratories Ltd. Plot 90, Sector 32, Gurgaon Haryana122001, India Tel: +91-124-4135143 / Mob: 9810042540 e-mail: email@example.com USA Contact: Charles M. Caprariello Vice President, Corporate Communications Ranbaxy Inc. (609) 720-5615 email : firstname.lastname@example.org
|SOURCE Ranbaxy Laboratories Limited|
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