Asia Spotlight: Ranbaxy CEO Arun Sawhney On “Thrilling” Days Of Atorvastatin Approvals And What’s Next
Atorvastatin launch “reinforced the belief in the Indian generic companies,” Sawhney says. Approval of anti-malarial Synriam, the first novel drug developed in India, will lead to “belief that we from India can also develop new products.”
You may also be interested in...
Ranbaxy launches generic atorvastatin despite not having reached a final settlement with FDA on GMP violations and data integrity issues. Teva’s role in Ranbaxy’s approval and launch is unclear, although the company will get a cut of the first-filer’s profits during the 180-day exclusivity period.
TOKYO - Daiichi Sankyo has initiated operations for its Ranbaxy-supported generics subsidiary in Japan - Daiichi Sanyko Espha - a positive step for the company's established products plans as it awaits news on U.S. FDA action on Ranbaxy
U.S. FDA Nails Ranbaxy On Charges Of Falsifying Data; Halts All Application Reviews From Paonta Sahib Plant
MUMBAI - India's largest drug maker Ranbaxy received a body blow after the U.S. Food and Drug Administration initiated a new regulatory action against the company's Paonta Sahib-based manufacturing plant in India. The drug regulator halted review of drug applications from the manufacturing plant due to evidence of falsified data and invoked the Application Integrity Policy