Indoco Remedies gets USFDA ANDA nod for Glycopyrrolate Injection

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.

Mumbai: Drugmaker Indoco Remedies recently informed the bourses that Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection 0.2 mg/ml filed from the company'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.

Read Also: Indoco Remedies successfully clears USFDA inspection of CRO facility AnaCipher

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

Headquartered in Mumbai, Indoco Remedies has 9 manufacturing facilities, 6 of which are for FDFsand 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc.

The company Indoco has 9 domestic marketing divisions with a strong brand portfolio in various therapeutic segments including Respiratory, Anti-Infective, Dental Care, Pain Management, Gastro-intestinal, Ophthalmic, Cardiovascular, Anti-Diabetics, Anti Obesity, etc.

Top Indoco brands include Cvdoparn, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G, Sensoform, Sensodent KF, Karvol Plus, Glychek, Kidodent, Carmicide, Bactogard, etc. On the international front, Indoco has tie-ups with large generic companies like Watson (Actavis)- USA and ASPEN-SouthAfrica.

Read Also: Indoco Remedies Parkinsons drug Rasagiline gets USFDA okay