Glenmark Pharmaceuticals to address USFDA’s observation
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi
Glenmark is the first company in India to market the innovative FDC of Indacaterol
Glenmark Pharmaceuticals announced its financial results for the fourth quarter ended March 31, 2022
'Hello Skin' has been developed in collaboration with the IADVL (Indian Association of Dermatologists, Venereologists and Leprologists)
A total of five observations for Goa and 17 for Monroe
According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million
Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA
The innovative Fixed-Dose Combination will help improving the glycemic control among adult patients with insulin resistance, those whose diabetes is uncontrolled by metformin; and also those who require addition of Teneliglitptin and Pioglitazone as separate drugs.
GRC 54276 has shown tumour cell killing ability in preclinical studies as a single agent and as well in combination with checkpoint inhibitors, making it a high-priority target in immuno-oncology
The company plans to launch the product immediately
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