Zydus Cadila Gets US FDA Approval for Glycopyrrolate Injection


The pharmaceutical company ‘Zydus Cadila’ has recently announced that, it has received the final approval from the US FDA for the purpose of marketing the Glycopyrrolate Injection in the Single-Dose Vials of Strengths 0.2 mg/mL and 0.4 mg/2 mL and 1 mg/5 mL and 4 mg/20 mL Multiple-Dose Vials.

The Glycopyrrolate injection has been mainly used before the surgery for the purpose of decreasing the volume of the secretions from lungs, mouth and stomach. The injection can also be used before or during the process of the surgery for the purpose of maintaining the normal beating rhythm of the heart. The injection is also used for the purpose of countering the effects of some of the other medicines that can possibly slow down the heartbeat or might also produce the excessive secretions when the injection is used during the surgery.

The Glycopyrrolate injection can possibly be used in the adult people as an adjunctive therapy for the treatment of the disease called as gastrointestinal ulcer when the rapid effect of medicine is required for when the oral medication is not tolerable.

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The drug is going to be manufactured at the injectable manufacturing facility of the Zydus Cadila group, which has been located at CHL-Jarod, near Vadodara, Gujarat, India, and the company is now having around 324 approval and the company has also filed more than 400 ANDAs since the filing process started in the financial year 2003-04.