INDOCO REMIDIES gets USFDA nod to market medicine to treat acidity

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Stock Exchanges, Mumbai headquartered pharma company Indoco Remedies Ltd said of having got approval from USFDA (US Food & Drugs Administration) to market medicine, to treat acidity and gastric secretions.

The press-release as submitted by the company to the Indian Bourses, titled – “Approval of Glycopyrrolate ANDA filed from Indoco’s Goa Plant II” read 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.

Commenting on this encouraging development, Ms. Aditi Kare Panandikar, Managing Director – Indoco Remedies Ltd., said, “This is the first injectable ANDA approval from our sterile facility (Goa II) after resolution of the Warning Letter. This ANDA has been filed through our partner in US and the product is slated for launch in the last quarter of the current financial year.”


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