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USFDA approves Glycopyrrolate ANDA filed from Indoco Remedies’ Goa Plant II

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The United States Food & Drug Administration (USFDA) has approved Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection 0.2 mg/ml filed from Indoco Remedies’ Goa Plant II on behalf of its partner in the US. 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 $120 million.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.

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