Unibest

Pipeline Database

UB899

Duloxetine Hydrochloride Enteric-coated Tablets

UB899

ProductDuloxetine Hydrochloride Enteric-coated Tablets
Strength20mg;30mg;60mg
IndicationsMajor depressive disorder; Generalized anxiety disorder; Diabetic peripheral neuropathic pain; Fibromyalgia; Chronic musculoskeletal pain
TherapeuticsPsychiatry; Anesthesiology
GMPCN - NMPA
RegistrationChina
ModalitiesSmall Molecule

Exclusive Summary

  • Covers dual indications for depression and chronic neuropathic pain, targeting a massive global market of over 300 million patients with robust rigid demand.
  • Recognized as a first-line classic SNRI drug recommended by multiple global guidelines, featuring a full range of dosages (20/30/60mg) to perfectly meet clinical titration and maintenance needs.
  • With originator patents fully expired, it leverages China's highly competitive supply chain cost advantages to provide overseas distributors with substantial profit margins for local bidding.
  • The enteric-coated formulation presents specific technical barriers; the supplier ensures stable delivery and provides standard CTD dossiers to support rapid regulatory registration overseas.

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