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Mumbai (Maharashtra) [India], May 24 (ANI/PRNewswire): Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr®1 Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc.
Glenmark Pharma gets USFDA nod for Icatibant injection
By IANS |
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Chennai, May 24 : Pharma major Glenmark Pharmaceuticals Limited on Monday said it has received the final approval from the United States Food & Drug Administration (USFDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.
The injection is the generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc.
According to Glenmark, this is the company s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.