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SOURCING

Reference listed drugs

Innovator reference and comparator products from the market of origin your filing requires.

Reference listed drugs
01What this covers

The exact reference your filing names

A bioequivalence study is only as defensible as the reference product it was run against. Obtaining that product — correct strength, correct market of origin, sufficient remaining shelf life, documentation that survives regulatory review — is routinely the slowest step in a generic development programme.

It becomes considerably harder when the reference is discontinued, supply-restricted, sold only through hospital channels, or marketed in a single country where you have no presence. That is the category we work in.

What is included

  • FDA and EMA approved reference products
  • Sourced from the market of origin your filing requires
  • Comparator supply for clinical trial programmes
  • Restricted-distribution and limited-supply products
  • Batch and expiry confirmed before purchase
  • Full purchase documentation and chain of custody
02Who this is for

Where this service earns its place

01

Generic manufacturers

Reference product for bioequivalence, from the market your filing names.

02

Contract research organisations

Comparator supply matched to the study window.

03

R&D and formulation teams

Innovator product for development and characterisation work.

04

Regulatory consultants

Sourcing documentation that survives review.

03How ordering worksReply within one working day

From first enquiry to delivered goods

Enquiry and quote

Send the product, strength, quantity and destination. We reply with availability, landed pricing and the documents your market needs.

Confirm and document

Specification agreed, registration and export paperwork prepared, supply plan confirmed before anything ships.

Source and verify

Product from licensed sources only, with certificate of analysis, batch records and packaging checked before dispatch.

Ship and hand over

Freight booked, cold chain held, documents travelling with the goods, and the temperature record handed over at delivery.

04Questions

What buyers ask before they commit

Which market can you source the reference from?

The market of origin your filing requires. Which market that is depends on the authority you are filing with, so we confirm the requirement before sourcing rather than after.

Do you confirm batch and expiry before buying?

Yes. Batch and remaining shelf life are confirmed against your study window before purchase, because a reference product that expires mid-study is of no use to the filing.

Can you source restricted or discontinued products?

That is the category we work in — hospital-only distribution, limited supply, and products marketed in a single country. Feasibility is confirmed honestly before you commit.

What do you need from me?

The product, strength and pack size, the reference market your authority requires, the quantity, and your study window. Registration details and the intended purpose are needed for the purchase documentation.

What documentation comes with the product?

Full purchase documentation and chain of custody, so the sourcing stands up when the dossier is reviewed.

Have a question about reference listed drugs?

Send us the specifics — the product, the destination, the quantity — and you will get a direct answer rather than a brochure.

Send an enquiry