Last Updated on October 7, 2024 by The Health Master
USFDA approval
Indoco Remedies, a leading pharmaceutical company, has achieved a significant milestone with the U.S. Food and Drug Administration approval (USFDA approval) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC).
This generic equivalent of Zyrtec Allergy Tablets, 10 mg, produced by Johnson & Johnson Consumer Inc., marks a significant step forward for Indoco’s presence in the U.S. market.
Manufacturing and Distribution
Indoco’s USFDA approval Cetirizine Hydrochloride Tablets USP, 10 mg, will be manufactured at its state-of-the-art facility located in Verna Industrial Area, Goa, India.
This modern manufacturing facility adheres to stringent quality standards and regulatory requirements, ensuring the production of high-quality and safe medications.
Therapeutic Benefits
Cetirizine is a widely used antihistamine medication that provides effective relief from symptoms associated with allergies, such as:
- Hay fever: Sneezing, runny nose, itchy eyes, and congestion
- Other allergic conditions: Urticaria (hives) and angioedema (swelling)
By offering a generic alternative to Zyrtec, Indoco aims to provide patients with a more affordable option for managing their allergy symptoms.
Company Statement
Aditi Panandikar, Managing Director of Indoco Remedies, expressed her enthusiasm about the USFDA approval, stating, “This achievement underscores Indoco’s dedication to delivering high-quality and affordable healthcare solutions to global markets.”
“We are proud to contribute to providing effective allergy relief medicines and remain committed to expanding our portfolio in the over-the-counter (OTC) space.”
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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