USFDA approves Glycopyrrolate ANDA filed from Indoco's Goa Plant II

Indoco Remedies announced that Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection 0.2 mg/ml filed from Indoco's Goa Plant II on behalf of its partner in the US, has been approved by the United States Food & Drug Administration (USFDA).

Glycopyrrolate is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions. The market size of this product in the US is US$ 120 million.

Powered by Capital Market - Live News