Drug Approval | April 09, 2025
Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s
Raichur site is the group’s largest API facility and part of a wider network of seven sites
Raichur site is the group’s largest API facility and part of a wider network of seven sites
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
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
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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