Indoco Remedies Receives ANDA Approval 10mg for Cetirizine Hydrochloride Tablets USP by FDA
Indoco Remedies receives US FDA final ANDA approval for cetirizine hydrochloride tablets USP, 10 mg
Overview
Indoco Remedies Limited, a fully integrated, research-oriented pharmaceutical company, announced the receipt of final approval from the US FDA 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.
About the Manufacturing Facility
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.
Comments from the MD
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 focused in expanding our portfolio in the OTC space."
About the Company: Indoco
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence.
The company’s turnover is US$ 212 million with a human capital of over 6000 employees, including over 400 skilled scientists and field staff who are the strength of the organization.
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