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Indoco Remedies receives US FDA final approval to market allopurinol tablets USP 200 mg

24 May 2025
Admin
News Article

Indoco Remedies receives US FDA final approval to market allopurinol tablets USP 200 mg"Indoco Remedies Receives US FDA Approval for Generic Allopurinol Tablets 200 mg

Indoco Remedies Ltd., a fully integrated, research-driven pharmaceutical company, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to market allopurinol tablets USP 200 mg—a generic equivalent to Zyloprim 200 mg by Casper Pharma LLC.

About the Drug: Allopurinol

Allopurinol is prescribed to:

Prevent or reduce high uric acid levels in the blood
Help patients with gout, kidney stones, or those undergoing cancer treatment who are at risk of uric acid buildup

Manufacturing & Quality Standards

The approved product will be manufactured at Indoco’s state-of-the-art facility located at:

L-14, Verna Industrial Area, Verna, Goa, India
This approval further validates Indoco’s global quality benchmarks and its capability to deliver products that meet international regulatory standards.

Executive Statement

“Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.”

Aditi Panandikar, Managing Director, Indoco Remedies Ltd.

Strategic Significance

Strengthens Indoco’s US generics portfolio
Expands access to affordable medications in the high-value US pharmaceutical market
Demonstrates the company’s continued focus on compliance, quality, and innovation

About Indoco Remedies Ltd.

Indoco Remedies is a research-oriented pharmaceutical company with a strong presence across global markets.

Key Highlights:

Annual turnover: USD 180 million
Employee base: Over 6,000 professionals
R&D strength: 400+ scientists and field experts
Global footprint with operations across formulations and APIs

This approval marks another milestone in Indoco’s mission to provide accessible, high-quality healthcare solutions to patients worldwide."