USFDA gives final nod to Zydus Cadila for Glycopyrrolate Injection

The drug will be manufactured at the injectables manufacturing facility in CHL-Jarod near Vadodara

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USFDA Approval
USFDA Approval

Last Updated on October 14, 2024 by The Health Master

Ahmedabad, India: Global pharmaceutical company Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market its glycopyrrolate injection, a generic version of the US Reference Listed Drug Robinul.

Glycopyrrolate injection

The strengths at which it can be marketed has been set at 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) for single-dose vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) for multiple-dose vials.

Glycopyrrolate is used before surgery to decrease the volume of secretions from the mouth, lungs and stomach. It can also be used either before or during surgery to maintain the heart’s normal beating rhythm.

In addition, it is used to counter the effects of some other medicines, which can possibly slow heartbeat or produce excessive secretions when used during surgery in some cases.

Glycopyrrolate injection can also be used in adults as an adjunctive therapy to produce a rapid effect for the treatment of gastrointestinal ulcer or can be used in case the patient is intolerant to oral medication.

The drug will be manufactured at the injectables manufacturing facility in CHL-Jarod near Vadodara, the company informed in a statement.

The approval for glycopyrrolate injection takes the total number of approvals for the Zydus group to 324, with over 400 ANDAs filed under their name since the commencement of the filing process in FY 2003-04.

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