Drug Approval | September 21, 2023
USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA
InvaGen has received 5 inspectional observations in Form 483
InvaGen has received 5 inspectional observations in Form 483
Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa
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
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
Subscribe To Our Newsletter & Stay Updated
