News | April 19, 2025
Aptar commences clinical study to accelerate FDA approval of SmartTrack
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
Zydus MedTech gets rights to market the innovative Transcatheter Aortic Valve Implantation (TAVI) technology in India, Europe and other select markets
Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA
The plant will have installed production capacity of 3,120 MT/month
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC) aims to accelerate the digital transformation of CMC development and manufacturing approaches
Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
The company does not expect this development to have any material impact on the current business operations
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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