Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
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
Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
Mankind Pharma commences the commercial operations newly set-up plant in Udaipur
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