News | October 17, 2023
Lupin enters into BTA with Lupin Manufacturing Solutions
Lupin enters into BTA with Lupin Manufacturing Solutions
Lupin enters into BTA with Lupin Manufacturing Solutions
The new gummy capabilities include a dedicated R&D lab, an automated production line, and bottle packaging solutions
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
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
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