Indoco Remedies Receives USFDA Approval for Allopurinol Tablets USP 200 mg

Indoco Remedies Ltd. has secured final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP, 200 mg. This approval authorizes the company to market a generic version of ZYLOPRIM 200 mg by Casper Pharma LLC in the United States.

Strategic Milestone and Market Significance

Allopurinol is widely prescribed to prevent or reduce high uric acid levels in the bloodstream, particularly in patients undergoing cancer treatment or suffering from kidney stones. The newly approved formulation will be manufactured at Indoco’s Verna facility in Goa, located at L-14, Verna Industrial Area.

Expanding US Generic Portfolio

This latest USFDA nod reinforces Indoco’s growing presence in the US generics space. With this approval, the company can tap into a significant market where ZYLOPRIM continues to be a widely used reference drug. The clearance also affirms the compliance and regulatory readiness of Indoco’s manufacturing infrastructure.

About Indoco Remedies

Indoco Remedies is a fully integrated pharmaceutical company with:

• Turnover of US$180 million
• Over 6,000 employees, including 400+ scientists and field personnel
• 11 manufacturing facilities (7 for finished dosage forms, 4 for APIs)
• R&D and CRO facilities approved by major global regulators including USFDA and UK-MHRA

The company generates 106 million annual prescriptions from over 2.4 lakh Indian doctors and operates 10 domestic marketing divisions across key therapeutic areas including gastro-intestinal, respiratory, cardiovascular, pain management, and gynaecology.

Key Brands

Prominent Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, ATM, Cital, Oxipod, among others.

International Partnerships

On the global front, Indoco has strategic tie-ups with leading generic pharmaceutical companies and continues to expand its footprint through regulatory approvals and product launches.

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