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.
As per a release issued by the company, 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, the release added.
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.
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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.