Drug Approval | May 01, 2025
USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility
The Subsidiary has received one inspectional observation in Form 483
The Subsidiary has received one inspectional observation in Form 483
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
The inspection concluded with 6 observations and none of them were related to Data Integrity
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
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