Zydus Cadila bags USFDA nod for Glycopyrrolate Injection

Ahmedabad: Pharma major , Zydus Cadila, has recently announced that the company has received final approval from the U.S. Food and Drug Administration (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).

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 gastrointestinal ulcer when 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 Vadodara (earlier known as Liva Pharmaceuticals Ltd.).

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

Medical Dialogues had earlier reported that Zydus had randomised the first patient into the Phase 2(b) Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled clinical trial to evaluate efficacy and safety of Saroglitazar Magnesium in subjects with Non-Alcoholic Steatohepatitis and Fibrosis.

Read also: Zydus randomises 'first patient' in phase 2 trial of Saroglitazar Mg in NASH

Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.