We’ll cooperate with USFDA: Ranbaxy
Pharmaceutical major Ranbaxy on Thursday said it has received a letter from the US health regulator indicating that all pending and approved Abbreviated New Drug Application (ANDA) from its Paonta Sahib facility have been added to a list maintained under a policy entitled Application Integrity Policy or AIP.
The company said it would continue to cooperate with USFDA and and no effort or action would be spared to timely protect key ANDA’s from Poanta Sahib.
In a statement, FDA had said it has found evidence of falsified data and test results in them.
“The FDA has said it has no evidence the drugs on the market are substandard and also that they comply with specifications upon testing,” Ranbaxy said. “It only indicated that all pending and approved ANDAs from Ranbaxy’s Paonta Sahib facility have been added to a list maintained under a policy entitled AIP. No products from Ranbaxy’s other manufacturing facilities are included in the AIP.”
The AIP is invoked when a company’s actions raise significant questions about the integrity of data in drug applications.