Marksans Pharma Farmingdale facility gets Establishment Inspection Report from USFDA Medical Dialogues Bureau14 Feb 2020 12:57 PM ISTNew Delhi: Drugmaker Marksans Pharma Ltd. recently announced that the company has received Establishment Inspection Report (EIR) from the US...
Sun Pharma gets 11 USFDA observations for Dadra plant, BSE asks for response: Report Farhat Nasim26 April 2019 2:20 PM ISTNew Delhi: Sun Pharmaceutical (Sun Pharma) Industries Ltd's Dadra plant has reportedly received 11 observations, "serious" in nature from the U.S....
Pfizer says USFDA accepts regulatory submissions for review of tafamidis Medical Dialogues Bureau16 Jan 2019 9:35 AM ISTPfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial...