Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,
These observations are procedural in nature and none of them are related to data integrity
The FDA issued Form 483 with one observation related to building and facility management
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
This approval authorizes the company to export Ibuprofen to the Chinese markets
The inspection concluded with 6 observations and none of them were related to Data Integrity
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
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
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
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
The product will be launched in Q1FY26
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