Drug Approval | May 03, 2025
USFDA inspection at Concord Biotech’s API facility at Dholka
These observations are procedural in nature and none of them are related to data integrity
These observations are procedural in nature and none of them are related to data integrity
Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)
The Subsidiary has received one inspectional observation in Form 483
Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
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
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