MoneyWorks4Me

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

01 Nov 2019 Evaluate

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.

Peers
Company Name CMP
Sun Pharma. Inds. 1756.90
Dr. Reddys Labs. 1195.10
Cipla 1303.30
Lupin 1960.00
Zydus Lifesciences 1115.10
View more..