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

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."
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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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