
UB865
ProductGuanfacine ER Tablets
Strength1mg, 2mg, 3mg, 4mg
IndicationsAttention deficit hyperactivity disorder
TherapeuticsPsychiatry
GMPUS - FDA
RegistrationUnited States
ModalitiesSmall Molecule
Exclusive Summary
- Fully US-FDA GMP certified with an approved US ANDA, demonstrating top-tier quality that facilitates rapid regulatory approval via reliance pathways in other markets.
- Functions as a non-stimulant ADHD medication with no addiction potential, bypassing the strict import, export, and distribution regulations typical for controlled substances.
- Addresses a massive global market with a 5%-7% prevalence of ADHD in youths (over 80 million patients), offering a full range of dosages (1-4mg) to meet standard clinical titration needs.
- Leverages China's cost-effective and highly reliable manufacturing to provide significant price advantages, empowering global distributors to win government tenders and outcompete originators.
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