Morepen Laboratories files its first US ANDA for sitagliptin tablets

The filing for sitagliptin tablets in three strengths marks Morepen's entry into integrated finished-dose development and regulatory filings in the US market

Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for sitagliptin tablets USP in 25 mg, 50 mg and 100 mg strengths, marking the company’s entry into integrated finished-dose development and regulatory filings.

 

The submission expands Morepen’s existing active pharmaceutical ingredient (API) and contract development and manufacturing organisation (CDMO) capabilities to include formulation development, bioequivalence, analytical validation, stability studies and regulatory batch manufacturing.

 

Sitagliptin is a DPP-4 inhibitor used in the treatment of type 2 diabetes. Its innovator product, Januvia, recorded worldwide sales of $1.6 billion in 2025, according to Merck’s 2025 annual report.

 

 

Sanjay Suri, managing director, Morepen Laboratories, said, “Our first ANDA submission brings together the scientific, manufacturing and regulatory skills needed to take an API through finished dosage development to a U.S. filing.” Suri further stated, “Alongside our planned Innovation Hub and investments in advanced chemistry and technology, this strengthens our ability to undertake specialized CDMO assignments and build long-term development partnerships.”

 

Morepen said it currently estimates 24-36 months from submission to approval and commercial supply, subject to FDA review, applicable facility inspections and patent and exclusivity requirements.

 

The relevant US sitagliptin phosphate salt patent is scheduled to expire in November 2026, with associated paediatric exclusivity extending until May 2027. Morepen said certain manufacturers have separate arrangements permitting earlier entry.

 

The company said the programme strengthens its ability to undertake specialised CDMO assignments spanning API development, finished-dose formulation and regulatory submissions. It plans to build on the capability through customer development programmes, technology transfers, co-development and licensing opportunities.

 

The ANDA, numbered 221758, was submitted on September 25, 2026. Morepen said the submission does not constitute FDA acceptance for substantive review, product approval or authorisation for commercial supply in the US.