Indoco Remedies receives USFDA approval for allergy drug Cetirizine Hydrochloride
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-10-04 03:30 GMT | Update On 2024-10-04 03:30 GMT
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Mumbai: Indoco Remedies Limited has announced the receipt of final approval from the USFDA for Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC), a generic equivalent of the Reference Listed Drug, Zyrtec Allergy Tablets, 10 mg of Johnson & Johnson Consumer Inc.
Cetirizine Hydrochloride Tablets USP, 10 mg will be manufactured by Indoco, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.
Cetirizine is used for relief of symptoms of hay fever and other allergic conditions.
Commenting on the achievement, Aditi Panandikar, Managing Director said, “This approval is a testament to Indoco’s commitment to delivering high-quality and affordable healthcare solutions to global markets. We are proud to contribute to providing effective allergy relief medicines and remain focussed in expanding our portfolio in the OTC space."
Indoco is a fully integrated, research-oriented pharmaceutical company. The Company’s turnover is US$ 212 million with a human capital of over 6000 employees, including over 400 skilled scientists and field staff.
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 UK-MHRA. 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 2,35,000 doctors belonging to various specialties. Indoco has 8 domestic marketing divisions a brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gyneacology 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, Dropizine, Noxa, Homide, Cal-Aid, etc.
On the international front, Indoco has tie-ups with large generic companies across the globe.
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