Zydus Cadila Gets Final Approval From US FDA For Pre-Surgery Injection

India-based pharma giant, Zydus Cadila received final approval from US Food and Drug Administration (FDA) for the Glycopyrrolate injection that is used before surgery to decrease the volume of secretions from the mouth, lungs and stomach.

Zydus Cadila Gets Final Approval From US FDA For Pre-Surgery Injection

Indian pharma giant Zydus Cadila also made the world's first plasmid DNA vaccine for Covid. (File)

Ahmedabad:

India-based pharma giant, Zydus Cadila received final approval from US Food and Drug Administration (FDA) for the Glycopyrrolate injection that is used before surgery to decrease the volume of secretions from the mouth, lungs and stomach.

"Zydus Cadila has received final approval from the USFDA to market Glycopyrrolate injection in the strengths of 0.2 mg/mL and 0.4 mg/2 mL (0.2 mg/mL) single-dose vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-Dose Vials, (US RLD: Robinul)," said the official press release by Zydus Cadila.

Glycopyrrolate is used before surgery to decrease the volume of secretions from mouth, lungs and stomach. It can also be used either before or during surgery to maintain heart's normal beating rhythm. It is also used to counter the effects of some other medicines, which can slow heartbeat or produce excessive secretions when used during surgery.

Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of a gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated. The drug will be manufactured at the group's injectables manufacturing facility at CHL-Jarod, near Gujarat's Vadodara.

The group now has 324 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in Financial Year 2003-04.

Ahmedabad-based pharma giant Zydus Cadila announced that it received Emergency Use Authorisation from Drugs Controller General of India (DCGI) for India's second indigenous vaccine, ZyCoV-D on August 20.

It is the world's first plasmid DNA vaccine for COVID-19. ZyCoV-D is a three-dose vaccine that will be administered on day zero, day 28th and then on the 56th day. ZyCoV-D, is a needle-free vaccine administered using the PharmaJet, a needle-free applicator, which ensures painless intradermal vaccine delivery.

This is for the first time that a technologically advanced vaccine has been successfully developed on the plasmid DNA platform for human use.

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