Drug Approval | October 23, 2023
Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur
The company is confident of addressing all the observations within the stipulated time
The company is confident of addressing all the observations within the stipulated time
Lupin enters into BTA with Lupin Manufacturing Solutions
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
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)
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
Mankind Pharma commences the commercial operations newly set-up plant in Udaipur
Clindamycin Phosphate Gel is used to treat acne
InvaGen has received 5 inspectional observations in Form 483
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