Drug Approval | August 17, 2023
Glenmark Pharmaceuticals receives sANDA approval for Tacrolimus Ointment, 0.03%
Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace
Glenmark's current portfolio consists of 184 products authorized for distribution in the U.S. marketplace
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).
Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
This product would be manufactured at Lupin's Nagpur facility in India
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
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