Drug Approval | April 17, 2025
Lupin receives EIR from USFDA for its injectable facility in Nagpur
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
The approved product, Mesalamine Suppositories 1000 mg, has an estimated U.S. market size of US$ 29 million
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
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
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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
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
The IND application supports the next phase of development of SBO-154
Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA
The inspection has concluded with four observations
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