News | April 16, 2025
Rising Pharma gets final approval from USFDA for Mesalamine Suppositories 1000 mg
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
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
The National IP Awards recognize outstanding contributions to India’s innovation economy through effective IP creation and commercialization
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 supply of these goods is set to commence within the first quarter of FY26
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
Sharma brings a wealth of expertise in optimizing manufacturing processes for fermentation-based APIs and sterile injectables
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