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  • Glenmark gets USFDA...

Glenmark gets USFDA nod for Single-Dose Prefilled Icatibant Injection

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-05-24T13:21:54+05:30  |  Updated On 24 May 2021 7:51 AM GMT
Glenmark gets USFDA nod for Single-Dose Prefilled Icatibant Injection

Mumbai: Drugmaker, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.The product is a generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic...

Mumbai: Drugmaker, Glenmark Pharmaceuticals Limited, today announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.

The product is a generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc.

This marks Glenmark's first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.

According to IQVIA sales data for the 12 month period ending March 2021, the Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe market achieved annual sales of approximately $223.4 million.

Glenmark's current portfolio consists of 172 products authorized for distribution in the U.S. marketplace and 44 ANDA's pending approval with the USFDA.

Read also: Glenmark FabiFlu knocks out top-selling Zincovit with April sales of Rs 352 crore

Glenmark Pharmaceuticals Ltd. is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.
Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.
Read also: Glenmark Ryaltris-AZ launched at breakthrough price of Rs 175 per pack in India





glenmark glenmark pharma news usfda icatibant injection firazyr injection 
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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