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
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
The company expects to launch this product through its marketing partner in the near future
The inspection has concluded with four observations
Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility
Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer
Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.
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