USFDA23 May 2025, 11:30 am
Indoco Remedies Receives Final USFDA Approval for Allopurinol Tablets USP 200mg
AI Summary
Indoco Remedies Ltd. has announced the final approval of Allopurinol Tablets USP 200 mg through its Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP. This approval allows Indoco to market a generic equivalent to the reference listed drug (RLD), ZYLOPRIM 200 mg of Casper Pharma LLC from USFDA. The product will be manufactured at Indoco's manufacturing facility in Goa, India. This development reflects Indoco's capability to deliver products of high-quality standards and provides impetus to their growth aspirations in the US market.
Key Highlights
- Indoco Remedies receives final approval from the USFDA for Allopurinol Tablets USP 200 mg
- The approval allows Indoco to market a generic equivalent to the reference listed drug ZYLOPRIM 200 mg of Casper Pharma LLC from USFDA
- Allopurinol Tablets USP 200 mg will be manufactured by Indoco Remedies Limited at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa - 403722 in India
- This development reflects Indoco's capability to deliver products of high-quality standards
- This approval provides impetus to Indoco's growth aspirations in an important market such as the US