Complex generic

A bridge for Korean medicines into the US market

High-barrier generic and first-generic products, developed with Korean manufacturing partners and commercialized in the United States.

How it works

Four steps to market

1

Identify

Source products with high development and regulatory barriers, and clear US demand

2

Develop

Partner with Korean cGMP-certified manufacturers on formulation and scale-up

3

Register

Lead FDA ANDA / 505(b)(2) filing, pricing, and regulatory strategy

4

Commercialize

Distribute through US partners under Arbormed Pharmaceuticals Inc.

Operating model

Complex Generic Business Model

Global development & manufacturing partners
01
Formulation
development
02
Product
development
03
cGMP
manufacturing
04
FDA approval
pathway
05
U.S.
commercialization
Arbormed
Regulatory strategy

Lead U.S. regulatory planning and submission strategy.

Market access

Build pricing, access and launch readiness for the U.S. market.

Commercial partnerships

Connect products with specialized distribution and sales partners.

Integrated U.S. value chain
Portfolio

Products in development

Four complex generic products are currently under contract, spanning injectable, hormonal, and iron-replacement therapies.

ProductIndicationManufacturing partnerStatus
SugammadexNeuromuscular blockade reversalPenmixANDA filed · Feb 2026
Calcitonin SalmonSevere osteoporosisEtico (India)US distribution contracted
Ferric CarboxymaltoseIron deficiency anemiaPenmixClinical development
Otic SolutionOtitis mediaUS-based partner (PTS)Exclusive US rights contracted