Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States
The products will be manufactured at the company's facility in Bengaluru
The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations
The products will be manufactured at the company's facility in Bengaluru
The inspection classification was determined by the agency as Voluntary Action Indicated
Erythromycin tablets is used to prevent and treat infections in many different parts of the body
Amneal’s site in Matoda is one of the company’s 12 pharmaceutical manufacturing facilities
Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia
The approval bolsters the company's Mycophenolate Mofetil portfolio
Pirfenidone Capsules had estimated annual sales of USD 95 million in the US
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