Morepen Laboratories submits first US ANDA for sitagliptin tablets
Morepen Laboratories has filed an Abbreviated New Drug Application with the US FDA for sitagliptin tablets in 25 mg, 50 mg and 100 mg strengths, marking its debut in finished-dose development for the US market.
Morepen Laboratories submitted ANDA 221758 to the US Food and Drug Administration for sitagliptin tablets in three dose strengths, signaling its entry into full-dose development and US regulatory filings. The move builds on the firm’s existing API and contract development and manufacturing organisation services, adding formulation work, bioequivalence studies, analytical validation, stability testing and regulatory batch production.
Sitagliptin, marketed as the diabetes drug Januvia, recorded $1.6 billion in global sales in 2025. Managing director Sanjay Suri highlighted that the filing combines the scientific, manufacturing and regulatory skills needed to bring an API to market in the United States. Morepen projects a 24-36-month period from filing to potential approval and commercial supply, pending FDA review, facility inspections and patent or exclusivity issues. The relevant US sitagliptin patent expires in November 2026, with pediatric exclusivity extending to May 2027, though some manufacturers may have earlier entry arrangements.
Why it matters
The filing shows Morepen's expansion into US drug manufacturing, potentially increasing competition for diabetes medicines.
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