
UB724
ProductLamotrigine ER tablet
Strength25mg 50mg 100mg 200mg 250mg 300mg
IndicationsPartial seizures; Primary generalized tonic-clonic seizures; Lennox-Gastaut syndrome
TherapeuticsNeurology
GMPUS - FDA; UK - MHRA
RegistrationUnited States
ModalitiesSmall Molecule
Exclusive Summary
- Holds both US-FDA and UK-MHRA GMP certifications and is already registered in the US, enabling fast-track regulatory reliance and immediate commercial distribution globally.
- Offers a complete ER portfolio (25mg to 300mg), perfectly aligning with strict clinical titration protocols to avoid SJS, backed by a high-barrier extended-release formulation.
- Targets a massive demographic of ~50 million epilepsy and ~40 million bipolar disorder patients globally, serving as a first-line, guideline-recommended maintenance therapy.
- Leverages China's cost-efficient manufacturing capabilities through a ready-to-go Distribution model, ensuring high profit margins and supply chain stability for overseas partners.
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