
Pipeline Database
UB515
Memantine Hydrochloride Sustained-release Capsules
UB515
ProductMemantine Hydrochloride Sustained-release Capsules
Strength28mg
IndicationsAlzheimer's disease
TherapeuticsNeurology
GMPUS - FDA
RegistrationUnited States; China
ModalitiesSmall Molecule
Exclusive Summary
- Leverage the prestigious US-FDA GMP certification and ANDA approval to fast-track registration in emerging markets (SEA, LatAm, MENA) that accept the US as a Reference Reference Country.
- The 28mg Extended-Release (ER) formulation offers a critical 'Once-Daily' clinical advantage over generic Immediate-Release (IR) tablets, significantly improving adherence in Alzheimer's patients and creating a product upgrade opportunity for partners.
- Capitalize on the massive demand driven by the global aging population with a solution that combines the cost-efficiency of Chinese manufacturing with top-tier US quality standards.
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