Indoco Remedies Ltd., a research-oriented pharmaceutical company, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for allopurinol tablets USP 200 mg. The approval allows the company to market a generic equivalent to Casper Pharma LLC's reference listed drug (RLD) Zyloprim 200 mg.
The newly approved medication is used to prevent or lower high uric acid levels in the blood, a condition that can lead to gout and other complications. It is also indicated for managing excess uric acid levels resulting from cancer treatments or in patients with kidney stones.
Aditi Panandikar, Managing Director of Indoco Remedies, highlighted the significance of this regulatory milestone: "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."
Manufacturing and Production Details
The generic allopurinol tablets will be manufactured at Indoco's facility in Verna Industrial Area, Goa, India. This facility is part of the company's manufacturing network, which includes 11 manufacturing facilities—seven for finished dosage forms and four for active pharmaceutical ingredients.
Indoco's manufacturing facilities have received approvals from major regulatory authorities worldwide, including the US FDA and UK MHRA, underscoring the company's commitment to maintaining international quality standards.
Company Profile and Market Position
Indoco Remedies is a fully integrated pharmaceutical company with a global footprint and an annual turnover of approximately US$180 million. The organization employs over 6,000 people, including more than 400 scientists dedicated to research and development.
In the domestic Indian market, Indoco maintains a strong presence with 10 marketing divisions and generates more than 106 million prescriptions annually from over 240,000 doctors across various specialties. The company's diverse brand portfolio spans multiple therapeutic segments, including gastrointestinal, respiratory, anti-infectives, ophthalmics, cardiovascular, anti-diabetics, pain management, and gynecology.
Some of Indoco's leading brands in India include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, and Glychek, among others. The company has also established strategic partnerships with major generic pharmaceutical companies globally to strengthen its international presence.
Strategic Importance of the Approval
The FDA approval for allopurinol tablets represents a significant step in Indoco's strategy to expand its presence in the lucrative US pharmaceutical market. Generic medications play a crucial role in increasing access to affordable treatments while maintaining the same safety and efficacy profiles as their brand-name counterparts.
For patients with conditions like gout, kidney stones, or those undergoing cancer treatment, the availability of generic allopurinol provides a cost-effective option for managing uric acid levels, potentially improving treatment adherence and outcomes.
This regulatory success further validates Indoco's research and development capabilities and its ability to navigate complex regulatory requirements in highly regulated markets like the United States.
