GNH USA partners with regulator-approved manufacturers and wholesalers in over 60 countries to source comparators, named-patient supply, biologics, biosimilars and original brands for clinical and commercial use in markets worldwide.
Who we partner with
The suppliers we work with
Manufacturers
Innovator and generic, finished dosage forms and APIs.
Wholesalers
Licensed distributors with full audit trails.
Specialty suppliers
Orphan drugs, biologics, cold-chain, controlled substances.
Documentation
What we need from you
Regulatory licence
Manufacturing or wholesale licence (FDA, EMA, MHRA, TGA, PMDA, CDSCO or equivalent).
GMP / GDP certificate
Valid certification from your competent authority.
ISO 9001 / 14001
Where applicable to your operations.
Site Master File
Or an equivalent quality manual covering your facility.
Recent inspection summary
FDA EIR, EU GMDP report or equivalent.
Product list & authorisation
Product list, pack sizes and territories of authorisation.
Manufacturing site details
Site address and contact for the responsible person.
Process
What happens next
- Step 01
Submit
Fill in the supplier form with company details and product categories.
- Step 02
Qualification
QA reviews documentation, runs background checks and may schedule a virtual or on-site audit.
- Step 03
Onboarding
Approved suppliers join our network with a designated buyer for ongoing demand.
- Step 04
Continuous compliance
Annual requalification, change-control and audit cadence.
Submit your facility