Indoco Remedies secures USFDA approval for Allopurinol Tablets to lower high uric acid levels in blood
Mumbai: Indoco Remedies Ltd. has announced the final approval of Allopurinol Tablets USP 200 mg through its Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP to market a generic equivalent to the reference listed drug (RLD), ZYLOPRIM 200 mg of Casper Pharma LLC from USFDA.
Allopurinol is used to prevent or lower high uric acid levels in the blood. It is also used to prevent or lower excess uric acid levels caused by cancer medicines or in patients with kidney stones.
This product, Allopurinol Tablets USP 200 mg, will be manufactured by Indoco Remedies Limited at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.
Commenting on the achievement, Ms. Aditi Panandikar, Managing Director said, “Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.”
Indoco is a fully integrated, research-oriented pharmaceutical company with a global presence. The Company has 11 manufacturing facilities, 7 for FDFs and 4 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by most of the Regulatory Authorities including USFDA and UKMHRA. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 106 million prescriptions annually from over 2,40,000 doctors belonging to various specialties. Indoco has 10 domestic marketing divisions, a brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infectives, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gynaecology, etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF, Aloja, Glychek, Kidodent, Subitral, Rexidin, MCBM 69, Methycal, Dropizin, Noxa, Homide, Cal-Aid, Ninaf, Cital-Uti, Otorex, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.
