The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Aurobindo will respond to the US FDA within the stipulated timelines
This product would be manufactured at Lupin's Nagpur facility in India
The maker of ivermectin/pyrantel, the #1 vet-recommended and #1 dog-preferred real beef chew introduces the latest innovation in its portfolio
Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications
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
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
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