Custom Development
Formulation development and scale-up connected to the API and target product.
Drug Product & ANDA development
From API knowledge
to finished-dose development.
Formulation, analytical work, stability, regulatory batches and dossier preparation connected through a demonstrated development program.
Discuss a development program
A demonstrated milestone
The first U.S.
ANDA submission.
The 28 September 2026 release announces Morepen's first U.S. ANDA submission for Sitagliptin Tablets USP, in 25 mg, 50 mg and 100 mg strengths.
The program brought together formulation and scale-up, analytical methods, impurity control, stability, regulatory batches, bioequivalence strategy and CRO coordination.
Read the filed announcementAnalytical & Stability
Methods, validation, impurity control and product-development data.
Custom Manufacturing
Regulatory-batch manufacture and program-specific manufacturing scope.
Clinical Supply
A program-specific service; product, site, quantity and quality requirements are confirmed for each assignment.
Pediatrics
A program-specific development area. Dosage-form experience, intended population and supporting studies require scope confirmation.
Dossier & Partnership Support
Bioequivalence coordination, data integration, technology transfer, co-development and licensing opportunities.
A separate business audience
Drug Product
is not the Rx catalogue.
This page serves pharmaceutical development partners. Prescription-medicines business information has its own destination.
Explore the Rx businessLet's build your next program.
Start a conversation about your API, development or manufacturing requirements.