Drug Approval | November 01, 2023
Lupin Mandideep plant gets USFDA green signal
The inspection of the facility conducted from August 7 to August 11, 2023
The inspection of the facility conducted from August 7 to August 11, 2023
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)
Clindamycin Phosphate Gel is used to treat acne
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
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