Ranbaxy gets letter from US FDA; says will take timely action
Stating that it has received a letter from the US health regulator on falsification of data and test results, Ranbaxy on Thursday said it would take appropriate action and respond in a timely manner.
By PTI |
MUMBAI: Stating that it has received a letter from the US health regulator on falsification of data and test results, Ranbaxy on Thursday said it would take appropriate action and respond in a timely manner.
In a filing to the Bombay Stock Exchange, the company said "Ranbaxy will analyse the letter and other information fully and respond appropriately in a timely manner."
It said that the letter from USFDA indicates that all pending and approved abbreviated new drug application (ANDA)'s from its Poanta Sahib facility added to 'Application Integrity Policy'.
AIP is invoked when a company's actions raise significant questions about the integrity of data in drug applications. AIP covers applications that rely on data generated by the Paonta Sahib facility only.
The company said that it would continue to co-operate with the USFDA. No effort or action would be spared to timely protect key ANDA's from Poanta Sahib.
Further, the FDA has said it has no evidence the drug on the market are substandard and also that they comply with specifications upon testing, the filing added.
"No products from Ranbaxy's other manufacturing facilities are included in the AIP," it said.
In a filing to the Bombay Stock Exchange, the company said "Ranbaxy will analyse the letter and other information fully and respond appropriately in a timely manner."
It said that the letter from USFDA indicates that all pending and approved abbreviated new drug application (ANDA)'s from its Poanta Sahib facility added to 'Application Integrity Policy'.
AIP is invoked when a company's actions raise significant questions about the integrity of data in drug applications. AIP covers applications that rely on data generated by the Paonta Sahib facility only.
The company said that it would continue to co-operate with the USFDA. No effort or action would be spared to timely protect key ANDA's from Poanta Sahib.
Further, the FDA has said it has no evidence the drug on the market are substandard and also that they comply with specifications upon testing, the filing added.
ADVERTISEMENT
"No products from Ranbaxy's other manufacturing facilities are included in the AIP," it said.
Start a SIP with as low as ₹500 with ET Money App!
Download
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
ADVERTISEMENT
