Pharma-11 is a US-based pharmaceutical sourcing and export company specializing in the global supply of FDA-approved Reference Listed Drugs (RLDs), Active Pharmaceutical Ingredients (APIs), and excipients to generic drug manufacturers, contract research organizations (CROs), and regulatory agencies worldwide.
Founded by a team of pharmaceutical industry veterans with combined decades of experience in drug development, regulatory affairs, and international trade, we understand precisely what generic manufacturers need — authentic, traceable, well-documented innovator products delivered on time and in full compliance.
Every RLD we supply is procured exclusively from authorized US wholesale distributors and licensed pharmacies, ensuring authenticity and full chain-of-custody from manufacturer to your facility.
Our regulatory team prepares complete import documentation packages — CoA, SDS, FDA approval letters, SMPC, country-specific import permits — tailored to each destination market's requirements.
From India and China to Brazil, the UAE, and South Africa — we have established trade lanes, import relationships, and deep knowledge of local regulatory requirements across every major pharma market.
Generic development timelines are tight. We respond to every inquiry within 48 hours with confirmed availability, pricing, lead time, and a full documentation checklist — no chasing, no delays.
Temperature-sensitive RLDs, biologics, and controlled substances are shipped under full GDP conditions with real-time tracking, temperature data loggers, and validated cold-chain packaging.
Our team combines backgrounds in pharmaceutical formulation, ANDA regulatory affairs, international pharma trade, and supply chain management — we speak your language and understand your timelines.
From small ANDA startups to large multinational generic manufacturers, we serve any organisation that needs authentic FDA-approved reference products — delivered with the paperwork that gets them through customs and past their regulatory agency.
A Reference Listed Drug (RLD) is an FDA-approved brand-name drug that generic manufacturers must use as the benchmark for bioequivalence testing. It is the legal standard that defines safety, efficacy, and quality for generics worldwide.
We source, verify, and ship authentic FDA-approved RLD samples to generic manufacturers and regulatory agencies worldwide — with complete chain-of-custody documentation.
Every RLD is sourced from authorized US distributors with full chain-of-custody documentation and lot traceability.
We provide CoA, SDS, prescribing information, FDA approval letters, and country-specific import documentation.
Temperature-controlled logistics for biologics and Schedule II–V controlled substances handled under DEA export authorization.
From sourcing and documentation to customs clearance and delivery — we manage the entire export process, including four specialized high-complexity programs.
We locate and procure any FDA-listed RLD, including discontinued brands, rare molecules, and high-demand innovator products.
Full dossier preparation including CoA, FDA approval letters, SMPC, labeling translations, and country-specific import permits.
GDP-compliant temperature-controlled shipping for biologics, vaccines, and heat-sensitive RLDs to any destination worldwide.
DEA-licensed export of Schedule II–V controlled RLDs with full INCB and importing country compliance support.
We coordinate with CROs to supply RLD comparators for bioequivalence studies, managing procurement timelines to match trial schedules.
Expert guidance on ANDA, dossier preparation, and market-specific regulatory strategy for Asia, LATAM, MENA, and EU markets.
Specialized programs for the industry's most demanding procurement scenarios.
Generic manufacturers need more than the finished RLD — they need the building blocks. Pharma-11 sources cGMP-certified Active Pharmaceutical Ingredients, functional excipients, and pharmaceutical-grade raw materials from a vetted global network, with full regulatory traceability from origin to your facility.
When a patient faces a life-threatening condition and no licensed treatment is available in their country, Named Patient Supply (NPS) programs provide a legal pathway to access. We manage the full supply and documentation chain with the urgency these cases demand.
Search our complete RLD catalog in real time. Products marked RLD are Reference Listed Drugs approved under section 505(c) of the FD&C Act.
Search by ingredient name or NDC number. Products with an RLD badge are Reference Listed Drugs (NDA innovators). Results update in real time.
Enter an active ingredient or NDC number above to search live RLD data. Try "atorvastatin", "metformin", or "amoxicillin".
Our RLD exports comply with the import requirements of major regulatory agencies worldwide.
Source authority. All RLDs listed in the Orange Book with NDA approval documentation.
Accepted as comparator products for European CHMP bioequivalence submissions.
RLD documentation packages meeting PMDA comparator and bioequivalence requirements.
Export documentation structured for ANVISA ANDA and bioequivalence study submissions.
Supporting WHO prequalification programs and UN agency procurement requirements.
Meeting CDSCO comparator drug import requirements for generic BE studies in India.
Tell us the RLD name, strength, quantity, and destination country. We respond within 48 hours.
We confirm availability, pricing, lead time, and prepare your full regulatory document package.
We handle US export permits, DEA authorization if required, and destination import paperwork.
Cold-chain or ambient shipping with real-time tracking and temperature logs to your site.
Submit your product inquiry and our team will confirm availability, pricing, and provide a full regulatory document package within 48 hours.
The Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness. It is the definitive reference for generic manufacturers seeking to develop ANDA submissions.
Open FDA Orange BookThe Orange Book uses TE codes (AA, AB, BC, etc.) to indicate whether a generic drug is considered therapeutically equivalent to its reference listed drug. AB-rated products are substitutable in most US states.
All Orange Book–listed drugs display associated patents and exclusivity periods. Generic applicants must address listed patents through Paragraph I–IV certifications in their ANDA submissions.
The RLD is the approved drug product to which a generic applicant refers in filing its ANDA. Pharma-11 supplies authentic RLDs sourced directly from Orange Book–listed NDA holders for BE studies.
NDA (505(b)(1) and 505(b)(2)) products appear as innovator entries. ANDA (505(j)) products are listed as approved generics with their corresponding TE codes and RLD references.
The European Medicines Agency (EMA) issues scientific guidelines governing the development, evaluation, and post-authorisation of medicines in the EU. Comparator products supplied by Pharma-11 support EMA bioequivalence and dossier submissions.
Browse EMA Scientific GuidelinesEMA's guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1) defines study design requirements, statistical criteria, and acceptable reference products for EU generic submissions.
For EMA submissions, the comparator must typically be a product authorised in a member state. FDA-approved RLDs may be used in certain cases with scientific justification under EMA's bridging study framework.
Generics applying under Article 10 of Directive 2001/83/EC must demonstrate bioequivalence to a reference medicinal product. Pharma-11 can source EMA-accepted comparators for EU-market BE studies.
All products exported to EU member states must comply with Good Distribution Practice (GDP) guidelines. Pharma-11 ships with full GDP documentation, temperature monitoring, and chain-of-custody records.
An Abbreviated New Drug Application (ANDA) is the regulatory pathway for generic drug approval in the United States under section 505(j) of the FD&C Act. ANDA sponsors must demonstrate pharmaceutical equivalence and bioequivalence to the Reference Listed Drug.
FDA ANDA Guidance CenterConfirm the Reference Listed Drug in the FDA Orange Book. The RLD is the approved drug product to which your generic must demonstrate pharmaceutical equivalence and bioequivalence.
Procure authentic RLD comparator from an authorized source (such as Pharma-11) for bioequivalence (BE) studies. Studies must meet FDA's statistical criteria: 90% CI of 80–125% for Cmax and AUC.
Compile the ANDA dossier in CTD (Common Technical Document) format. Key modules include pharmaceutical development, BE study reports, labeling, patent certifications, and manufacturing information.
Address Orange Book–listed patents with a Paragraph I, II, III, or IV certification. A Paragraph IV certification (challenging patent validity) triggers a potential 30-month stay of FDA approval.
FDA's Office of Generic Drugs (OGD) reviews the ANDA for completeness and approvability. Current GDUFA goal dates target 10-month review for standard ANDAs and 8 months for priority submissions.
Upon FDA approval, the product receives a Tentative or Final Approval letter. Final Approval allows commercial launch; Tentative Approval is issued when patent or exclusivity blocks remain.
Select a destination country and drug category to instantly surface the required documents, licensing restrictions, and special import pathways for that market. All results include direct links to the destination country's competent authority.
Select a destination country and drug category to instantly surface required documents, import restrictions, and official regulatory links for that market.
The checker will surface required documents, import restrictions, official agency links, and special pathways specific to your market and product type.