"Leaders in testosterone esters for Latin America, Africa and Eastern Europe."
High-quality pharmaceutical solutions for hormone replacement therapy. Over a decade of innovation, trust and commitment to men's health worldwide.
One line. One standard.
No exceptions.
At BioNordet, there are no "premium" or "economy" product lines. Every product bearing our name contains exactly the dosage stated on its label. Because under-dosing a medication is not a business model — it is a disservice to the patient and the prescribing professional.
Exact dosage, always
Every milligram declared on the label is present in the vial. No "lite" versions, no first-class and second-class tiers. A patient should not have to pay more to receive what they are rightfully owed.
Real regulation, not convenience
We choose to operate under demanding regulatory frameworks like BfArM (Germany) and the EMA (European Union), not in jurisdictions chosen for their permissiveness. Strict regulation is not an obstacle — it is a guarantee for the patient.
Public Certificate of Analysis
Every batch produced has a verifiable Certificate of Analysis (CoA) with HPLC, endotoxin, sterility and active ingredient content results. Full transparency, not empty promises.
ABOUT US
Dedicated to improving quality of life through excellence in hormone therapy.
BioNordet is a pharmaceutical laboratory specializing in the production and distribution of high-quality testosterone esters for male hormone replacement therapy (HRT).
Founded with the vision of bringing accessible, world-class hormonal treatments to underserved markets, we are now headquartered in Germany with an active presence in Latin America, North Africa and Eastern Europe.
Our portfolio includes 11 injectable products — testosterone esters and anabolic steroids —, all produced under strict Good Manufacturing Practices (GMP) and backed by a rigorous pharmacovigilance and quality control program.
The BioNordet team combines decades of biotechnology expertise with cutting-edge technology, ensuring the efficacy, purity and stability of every batch produced.
ETHICS & INTEGRITY
Our fundamental pillars guide every decision, from research to distribution.
Regulatory transparency
We comply with all local and international health regulations in every market we operate in, ensuring full traceability of our products.
Anti-underdosing
We reject the practice of offering "economy" versions with reduced active ingredients. Every BioNordet product contains the exact declared concentration, verified by independent HPLC analysis.
Access to healthcare
We work to make hormone replacement therapy accessible in emerging markets, with patient assistance programs for those in need.
Full traceability
Every unit produced has a traceable batch number from raw material to dispensing point. Documented and auditable chain of custody at all times.
Responsible jurisdiction
We operate under the region's most demanding regulations. We don't choose where to manufacture based on regulatory permissiveness, but on patient protection standards.
Sustainability
We implement clean production practices and responsible supply chain management, minimizing our environmental impact at every stage.
TESTOSTERONE ESTERS
High-purity injectable formulations for male hormone replacement therapy. Each product carries the BioNordet Laboratory brand.
INJECTABLE PRODUCTS
New therapeutic lines with the same GMP standards and full traceability.
QUALITY & CERTIFICATIONS
Every production batch undergoes over 40 quality controls before market release.
Certified raw materials
Active ingredients from audited suppliers with origin certification and purity above 99.5%.
HPLC analytical control
Each batch is analyzed by high-performance liquid chromatography to verify identity, potency and impurity profile.
Stability studies
Complete accelerated and long-term stability program per ICH guidelines, ensuring product integrity through expiry date.
Active pharmacovigilance
Post-marketing monitoring system with periodic safety reports and real-time adverse event database.
GMP
Good Manufacturing
Practices
ISO 9001
Quality
Management
ICH
International
Harmonisation
BfArM
German Federal
Authorization
PRODUCT AUTHENTICITY
Every BioNordet product includes a verification system so professionals and patients can confirm they are receiving a genuine product.
QR verification code
Present on every BioNordet package
How to verify your product
Locate the QR code
Every BioNordet package has a unique QR code printed on the secondary packaging and an alphanumeric security code under a scratch-off label.
Scan or enter the code
Use your phone camera to scan the QR or enter the alphanumeric code on our verification portal.
Instant confirmation
Receive instant confirmation with batch data: production date, expiry, Certificate of Analysis results and distribution chain.
REGULATIONS & HEALTH REGISTRATIONS
We operate exclusively under regulatory frameworks that prioritize patient safety over commercial convenience.
BfArM — Germany
All our products are authorized by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany's federal authority for drugs and medical devices, operating under European Medicines Agency (EMA) standards.
Good Manufacturing Practices (GMP)
Our production facility operates under current GMP certification with periodic inspections. Every process — from raw material reception to final packaging — is documented and validated.
International health registrations
Every market we operate in requires a local health registration. We do not distribute in countries where we cannot meet local regulatory requirements, regardless of the commercial opportunity.
Post-marketing pharmacovigilance
We maintain an active pharmacovigilance system with periodic reports to health authorities in each country. Adverse events are recorded, investigated and communicated transparently.
Important notice about pharmaceutical products
Medications must be manufactured under strict health regulations that guarantee the identity, potency, purity and quality of each product. Be wary of laboratories that offer differentiated "lines" of the same active ingredient at different quality or price levels. A properly manufactured medication has one version only: the one that meets the specification approved by the health authority. Anything else is, at best, an inferior product.
FREQUENTLY ASKED QUESTIONS
Answers to the most common questions about our products and processes.
PRESS
BioNordet expands testosterone esters distribution to five new African markets
The company closed distribution agreements in Algeria, Tunisia, Libya, Ghana and Nigeria, consolidating its continental presence with the full testosterone ester product line.
Read moreMixtes 250 obtains regulatory approval in three Eastern European countries
BioNordet's four-ester combined formulation received health authority approval in Ukraine, Moldova and Georgia, expanding access to hormone therapy in the region.
Read moreLaunch of TE-250 Pen: BioNordet's first auto-injector
The new subcutaneous self-administration device aims to improve treatment adherence with an ergonomic design and ultra-fine needle for reduced pain at each application.
Read moreCONTACT
Inquire about our products, distribution or healthcare professionals program.
Direct line
Healthcare professionals support
Headquarters
Hanauer Landstraße 291 · 60314 Frankfurt am Main · Germany
Production Center
Industriestraße 18 · 63225 Langen · Hessen · Germany
Pharmacovigilance
To report adverse events or safety inquiries:
pharmacovigilance@bionordet.com
