Search Result for : Us Food And Drug Administration

The Dollar Business Bureau Hyderabad-based pharmaceutical major Dr. Reddy's Laboratories Ltd. on Monday announced that it has signed a commercial deal with an Australian pharmaceutical company Hatchtech to jointly develop an innovative prescription head lice product Xeglyze Lotion. “As part of the agreement, Dr. Reddy's will pay Hatchtech an upfront amount of US$10 million, up to $50 million based on pre commercialization milestones and an undisclosed amount based on post-commercialization milestones, linked to achievements of annual net sales targets,” Dr. Reddy’s said in a statement. In September 2014, the Australian drug manufacturer announced positive results from its two pivotal Phase 3 clinical studies and evaluated Xeglyze Lotion as a potential candidate to treat head lice infestations. The studies were undertaken across 14 ...

Jayarama Emani | The Dollar Business The pharmaceutical industry appreciated the recent move by US Food and Drug Administration (USFDA) to incentivize those adopting a culture of quality in addition to its usual practice of pulling up those for manufacturing lapses. Speaking to The Dollar Business, Krishna Prasad, CEO & Director, Cito Healthcare (P) Ltd; said “I am glad the agency is taking pro-active and positive steps in encouraging compliance across the industry. In the past, we have the UK MHRA (Medicines and Healthcare Products Regulatory Agency) being appreciative of some of the GCP (Good Clinical Practice) measures adopted by a sponsor or a contract research location. USFDA too have been complementing more from the CFR (Code of Federal ...