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.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1847.30 |
| Dr. Reddys Lab | 1293.25 |
| Cipla | 1347.70 |
| Zydus Lifesciences | 938.90 |
| Lupin | 2377.90 |
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