Can Euro Biom supply single-batch RLDs for bioequivalence studies?

Yes. Bioequivalence study protocols typically require a single batch of the RLD to control batch-to-batch variability. Euro Biom sources from MHRA-authorised manufacturers and distributors and can supply with batch-level documentation including a Certificate of Analysis, original manufacturer batch number, expiry date and full chain-of-custody records.

What documentation is provided with an RLD supply?

Every RLD supply from Euro Biom is accompanied by a Certificate of Analysis from the manufacturer, a Certificate of Pharmaceutical Product where required, batch records, GDP-compliant transport and temperature monitoring records where relevant, and any export documentation needed for the destination country. Documentation is supplied in formats acceptable to FDA, MHRA, EMA and major regulators.

How quickly can Euro Biom source an RLD?

Lead times depend on the product and the manufacturer's allocation. For commonly available innovator brands sourced through standard UK distribution, supply can be arranged within days. For complex sourcing, restricted allocation products or rare reference standards, we provide a realistic lead time at the point of enquiry. We respond to all enquiries the same working day.

Reference Listed Drug Supply

Reference Listed Drug
Supply UK
for Bioequivalence & Regulatory Work

Euro Biom is an MHRA WDA-licensed UK pharmaceutical wholesaler supplying Reference Listed Drugs (RLDs) and innovator comparators for bioequivalence studies, ANDA submissions and regulatory dossiers worldwide.

MHRA WDA Licence No. WDA(H) 59239Granted 17 March 2026

Submit an RLD Enquiry How It Works

⚡ Same-day response to every enquiry · Mon-Fri 09:00-18:00 · WhatsApp us

What is a Reference Listed Drug

The benchmark
against which generics
are measured.

A Reference Listed Drug is the originator branded medicine identified by a regulator as the benchmark for generic equivalence. In the United States, the RLD is the product designated in the FDA Orange Book under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

In the European Union and United Kingdom, the equivalent concept is the reference medicinal product, the originator innovator authorised under a full marketing authorisation, against which a generic must demonstrate essential similarity, qualitative and quantitative composition equivalence and bioequivalence.

Sourcing the genuine RLD with verifiable provenance is critical. A bioequivalence study or regulatory dossier built on an unverified comparator can fail submission. Euro Biom supplies RLDs only through MHRA-authorised channels with full batch-level documentation.

FDA Orange Book EU Reference Medicinal Product MHRA WDA Sourced Full Documentation

"A bioequivalence study is only as defensible as the comparator behind it. Sourcing the RLD from a regulated UK pharmaceutical wholesaler protects the integrity of every downstream submission."

Who Needs RLDs

Generic Manufacturers,
CROs and Regulatory Consultants

RLD demand is concentrated among organisations preparing regulatory submissions, running clinical or bioequivalence studies, or building dossiers for global market authorisation.

💉

Generic Pharmaceutical Manufacturers

ANDA filings to the US FDA require bioequivalence demonstration against the listed RLD. EU and UK abridged generic applications under Article 10 require a reference medicinal product. RLDs are also used for in vitro dissolution profiling, BCS classification studies and as positive controls in formulation development.

🧪

Contract Research Organisations

CROs running bioequivalence and bioavailability studies on behalf of generic sponsors require single-batch RLD supply with full documentation. Protocol design typically specifies the comparator batch in advance, and the supplier must guarantee batch-level traceability for the full study duration.

📝

Regulatory and Dossier Consultants

Consultancies preparing CTD modules, regulatory dossiers and submission packages need verified RLD provenance to support comparator product information, package insert reviews, and Module 3 quality data. Documentation must satisfy FDA, MHRA, EMA and emerging-market regulators.

The Euro Biom RLD Service

Verified provenance.
Single-batch sourcing. Full documentation.

RLD work is unforgiving. The wrong batch, missing paperwork or an unverified source can derail a submission. Our service is built around the regulatory expectations of FDA, MHRA, EMA and emerging-market authorities.

MHRA-Verified Manufacturer Provenance

Every RLD is sourced through MHRA-authorised manufacturers, original brand holders or licensed UK wholesalers. Provenance is documented from manufacturer batch release through to delivery, with no intermediate brokers or unverified intermediaries in the chain.

WDA(H) 59239 sourcing only

Single-Batch Sourcing for BE Studies

Bioequivalence study protocols typically require all RLD doses to come from a single manufacturer batch. We confirm batch availability before supply, reserve quantities for the full study, and document batch number, manufacture date and expiry on every shipment.

Batch consistency guaranteed

Full Regulatory Documentation

Every supply includes a Certificate of Analysis from the manufacturer, batch records, GDP-compliant transport documentation, and where required a Certificate of Pharmaceutical Product. Documentation formats are acceptable to FDA, MHRA, EMA and major emerging-market regulators.

CoA, CoPP, batch records, transport logs

Cold Chain and GDP Compliance

RLDs requiring temperature-controlled storage, including biologics, vaccines and refrigerated formulations, are handled under full UK Good Distribution Practice. Temperature monitoring records accompany every shipment, and our contract warehouse is GDP-audited.

+2 to +8 cold chain capable

RLD Documentation

Every document
your dossier needs.

RLD documentation is the difference between a regulatory submission that passes review and one that returns a deficiency letter. Euro Biom provides the full documentation package as standard with every supply.

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Certificate of Analysis (CoA)

Original manufacturer CoA showing batch number, manufacture and expiry dates, identity, assay, impurities and dissolution data where applicable.

Certificate of Pharmaceutical Product (CoPP)

WHO-format CoPP issued by the MHRA where required for export and submission to receiving regulators in emerging markets.

Batch Records and Manufacturer Traceability

Documentation linking each unit supplied to the original manufacturing batch, including release records and authorised distributor chain of custody.

Package Insert and SmPC

UK Patient Information Leaflet and Summary of Product Characteristics as authorised by MHRA, supplied for comparator product information in dossier work.

Transport and Cold Chain Records

Temperature-monitored shipping records, including data logger output where relevant, evidencing GDP-compliant handling from origin to delivery.

UK Export Documentation

Commercial invoice, packing list, certificates of free sale where required, and any country-specific export paperwork. We manage UK customs clearance as part of the service.

How It Works

From RLD Identification
to Documented Delivery

Our five-step process is built around the regulatory submission timelines and study protocols our clients work to.

Step 01

RLD Identification

Confirm the exact innovator brand, INN, strength and formulation. Cross-check FDA Orange Book or EU reference medicinal product designation.

Step 02

Sourcing Assessment

Identify MHRA-authorised manufacturers and distributors, confirm batch availability, present sourcing options with indicative lead times.

Step 03

Verification and Reservation

Verify batch provenance, reserve required quantities for single-batch BE studies, lock in batch number and expiry for protocol records.

Step 04

Documentation Pack

Compile CoA, CoPP, batch records, package insert, SmPC, transport and export documentation in regulator-acceptable format.

Step 05

Shipment and Delivery

Dispatch via specialist pharmaceutical logistics with temperature monitoring where required. Customs clearance support for international consignments.

Where RLD Demand Is Highest

Therapeutic Areas We Supply

RLD requirements are most concentrated in therapeutic areas with active generic competition, complex formulation challenges or patent expiries driving ANDA pipelines.

🧡

Cardiovascular

High-volume RLD demand for ACE inhibitors, ARBs, statins, anticoagulants and antiarrhythmics with extensive generic pipelines.

🧠

CNS and Neurology

RLDs for SSRIs, SNRIs, antipsychotics, anticonvulsants and Parkinson's therapies, including modified-release formulations requiring complex BE designs.

🔬

Oncology

Innovator branded oncology RLDs for tyrosine kinase inhibitors, hormone therapies, cytotoxics and supportive care, often with restricted allocation.

⚡

Hormones and Endocrinology

Reference standards for thyroid hormones, oral contraceptives, HRT, insulins and GLP-1 analogues with active biosimilar pipelines.

🌡

Antibiotics and Antivirals

RLDs for fluoroquinolones, beta-lactams, antiretrovirals, hepatitis C therapies and antifungals supporting global generic submissions.

💊

Respiratory

Inhaled corticosteroids, LABA, LAMA combinations and dry powder inhaler innovator brands requiring rigorous in vitro and PK comparator work.

🩸

Diabetes and Metabolic

DPP-4 inhibitors, SGLT2 inhibitors, biguanides and combination products driving large-volume RLD demand for global generic and biosimilar submissions.

👨‍⚕️

Other Therapeutic Areas

RLD supply for any therapeutic class including dermatology, gastroenterology, urology and ophthalmology. Submit your specific requirement for a sourcing assessment.

Ready to Source Your RLD?

Tell us the brand, INN, strength and quantity. We respond the same working day with sourcing options, batch availability and a documentation preview. No commitment required at enquiry stage.

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Frequently Asked Questions

RLD Supply, Explained

Common questions from generic manufacturers, CROs and regulatory consultants.

What is a Reference Listed Drug (RLD)?

A Reference Listed Drug is the originator branded product against which a generic equivalent is benchmarked for bioequivalence. In the United States the RLD is identified in the FDA Orange Book. In the EU and UK the equivalent concept is the reference medicinal product, the innovator authorised under a full marketing authorisation.

Why do generic manufacturers need RLDs from the UK?

Generic manufacturers, CROs and regulatory consultants need RLDs for bioequivalence studies, ANDA submissions to the FDA, EU and UK abridged applications, in vitro dissolution work and BCS classification. Sourcing from the UK ensures provenance, GDP cold chain and full documentation accepted by all major regulators.

Can you supply single-batch RLDs for BE studies?

Yes. Bioequivalence protocols typically require a single batch of RLD to control batch-to-batch variability. We source from MHRA-authorised channels, reserve quantities for the study, and document batch number, manufacture date and expiry on every shipment.

What documentation comes with an RLD supply?

Every RLD supply includes a manufacturer Certificate of Analysis, Certificate of Pharmaceutical Product where required, batch records, GDP transport and temperature monitoring records, package insert and SmPC, and full UK export documentation. All formats are acceptable to FDA, MHRA, EMA and emerging-market regulators.

How quickly can you source an RLD?

For commonly available innovator brands sourced through standard UK distribution, supply can be arranged within days. For restricted allocation products or rare reference standards, we provide a realistic lead time at enquiry. We respond to all enquiries the same working day.

Do you supply RLDs internationally?

Yes. We export RLDs from the UK to clinical research organisations, generic manufacturers and regulatory consultancies in the United States, India, GCC, Europe and Africa. Our MHRA WDA covers export, and we manage all UK export documentation as part of the service.

What information do I need to provide for an RLD enquiry?

Brand name and INN of the innovator, strength and formulation, quantity required, single-batch requirement if applicable, intended use such as BE study or ANDA filing, destination country, and any urgency. The more detail you provide, the faster we can confirm sourcing.

Related Resources

Further reading for generic manufacturers, CROs and regulatory consultants.

Service

Named Patient Medicine Supply for Hospitals and Institutions

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Service

Managed Access Programs UK: Compassionate Use and Early Access

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Compliance

Our Regulatory Credentials and MHRA WDA Documentation

View compliance →

Guide