Strategic active ingredients targeting life-threatening systemic fungal infections and resistant bacterial pathogens for Central Eastern European hospital networks and injectable drug manufacturers.
Echinocandin class lipopeptide API engineered for invasive candidiasis and invasive aspergillosis formulations. Fully validated cGMP production with low endotoxin limits optimized for sterile lyophilized injectable manufacturing in Hungary.
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Cyclic lipopeptide API targeting Gram-positive bacteremia and complicated skin structure infections (cSSSI). Ultra-pure synthesis path complying with European Pharmacopoeia (Ph. Eur.) standards for hospital parenteral solutions.
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Semi-synthetic lipopeptide antifungal API inhibiting 1,3-beta-D-glucan synthesis. Supplied with complete technical documentation package for fast-track dossier filings with Hungary's OGYÉI authority.
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Critical glycopeptide antibiotic API vital for treating severe MRSA infections and enterococcal endocarditis. Standardized particle size distribution and tight impurity profiling for high-yield formulation processing.
View Details & SpecAnalyzing the regulatory landscape, industrial clusters, and technical API imperatives driving the Central and Eastern European (CEE) drug formulation hub.
Hungary boasts one of the most sophisticated pharmaceutical manufacturing infrastructures in Central Eastern Europe. Driven by legendary domestic players like Richter Gedeon, Egis, and major multinational manufacturing nodes in Budapest, Debrecen, and Gödöllő, the Hungarian market commands a high standard for raw active ingredients. The local industry demands APIs with strict compliance to European Pharmacopoeia (Ph. Eur.) specifications, minimal impurity profiles, and bulletproof supply security.
As global supply chains face geographic concentration risks, Hungarian pharmaceutical drug product manufacturers are actively diversifying their supplier matrices. Sourcing high-purity APIs—specifically complex peptides, anti-infective lipopeptides, and specialized metabolic building blocks—requires partners who understand both international cGMP and local regulatory nuances overseen by the National Institute of Pharmacy and Nutrition (OGYÉI).
Securing market access in Hungary demands absolute alignment with European Union directives. Active Pharmaceutical Ingredients (APIs) imported into or synthesized within Hungary must be backed by comprehensive regulatory assets. This includes Certificate of Suitability (CEP) issued by the EDQM, Active Pharmaceutical Ingredient Master Files (APIMF / ASMF), and US FDA Drug Master Files (DMF) for global export platforms.
At Gentolex, our API manufacturing framework enforces stringent Quality Risk Management (ICH Q9) and Pharmaceutical Quality System (ICH Q10) principles. Every batch supplied to Hungarian formulators undergoes rigorous Quality Control testing, complete with Qualified Person (QP) release support, residual solvent analyses under ICH Q3C, and elemental impurity assessments adhering to ICH Q3D guidelines.
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
With an overall factory construction area of 250,000 square meters built under international cGMP standard, we offer flexible, scalable, and cost-effective solutions tailored for pharmaceutical manufacturers, research institutes, and biopharma innovators across Hungary and the broader EU footprint.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions.
Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
Process optimization, scale-up technology transfer, analytical method validation (HPLC/LC-MS), lab setup consultation, and FDF license-out solutions.
For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.
Pioneering Solid-Phase Peptide Synthesis (SPPS) and Liquid-Phase Peptide Synthesis (LPPS) technology platforms for local pharmaceutical discovery and generic manufacturing.
From milligram quantities for preclinical academic research in Hungarian university hubs (Budapest, Szeged, Debrecen) to multi-kilogram commercial batches under cGMP. We specialize in complex sequences, side-chain modifications, cyclic peptides, and lipopeptide conjugation.
Supplying specialized amino acid building blocks essential for solid-phase peptide production. High-grade Fmoc, Boc, and Alloc protected derivatives with stringent purity controls to maximize coupling efficiency and yield.
Rigorous physical-chemical characterization ensuring full audit-readiness for EU regulatory submission. Detailed DMF and ASMF packages supporting accelerated licensing across European member states.
| Quality Parameter | Gentolex cGMP API Standard | EP / USP Pharmacopoeia Requirement | Analytical Method |
|---|---|---|---|
| Chemical Purity (HPLC) | ≥ 99.5% (Individual Impurity < 0.10%) | ≥ 98.0% - 99.0% | Reverse-Phase HPLC-UV / CAD |
| Bacterial Endotoxins | < 0.05 EU/mg (Customizable for Injectables) | < 0.25 EU/mg | LAL Kinetic Chromogenic Method |
| Residual Solvents | Below ICH Q3C Option 1 Limits | Standard ICH Compliance | Headspace Gas Chromatography (HS-GC-FID) |
| Heavy Metals / Elements | Strict Compliance with ICH Q3D | General USP <232> / <233> | ICP-MS Validation |
Latest scientific insights, product releases, and peptide API developments from Gentolex global research team.
Introduction to Selank Acetate API Selank Acetate API is a synthetic heptapeptide active pharmaceutical ingredient (API) composed of the amino acid sequence Thr-Lys-Pro-Arg-Pro-Gly-Pro (TKPRPGP). Originally developed through neuropharmacological research, Selank is a derivative of the endogenous sequence...
Trusted Thymosin Beta-4 API Manufacturer and Global Peptide Supplier As a professional Thymosin Beta-4 API manufacturer and supplier, we provide high-quality Thymosin Beta-4 peptide API solutions for biotechnology companies, pharmaceutical research organizations, and clinical development...
Introduction BPC-157 API is a synthetic pentadecapeptide that has gained increasing attention in peptide research due to its potential biological activities related to tissue repair, gastrointestinal protection, angiogenesis, and inflammatory regulation. As a peptide active ingredient...
With the continuous development of neuroscience, peptide technology, and life science research, neuroactive peptides have become an important area of scientific investigation. Semax, a synthetic peptide derived from an ACTH fragment, has attracted attention among researchers...
SS-31 (Elamipretide) API SS-31 API, also known as Elamipretide, MTP-131, Bendavia, and SS31, is a synthetic mitochondria-targeting tetrapeptide designed to bind cardiolipin in the inner mitochondrial membrane. By stabilizing mitochondrial structure and supporting cellular bioenergetics...
Explore our extended range of active pharmaceutical ingredients, weight management compounds, metabolic regulator APIs, and intermediate reagents for commercial supply in Hungary.
PDE5 inhibitor API synthesized under strict GMP controls. Consistent crystal habit and micronization available for immediate oral solid dose formulation in EU markets.
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High-purity Sildenafil Citrate raw material API. Fully documented impurity profile adhering to European Pharmacopoeia (Ph. Eur.) monograph requirements.
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Potent PDE5 inhibitor API available for immediate commercial procurement, backed by complete stability studies and COA validation.
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Gastrointestinal lipase inhibitor API engineered for anti-obesity capsules and oral dosage forms. High stability and batch-to-batch uniformity.
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Non-steroidal anti-androgen compound specialized for topical dermatological research and cosmetic formulation development.
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Metabolic active isomer crucial for endocrinology research, metabolic studies, and specialized diagnostic kit manufacturing.
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High-purity zwitterionic detergent and lipid reagent widely utilized in membrane protein NMR spectroscopy and biophysical research.
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Specialized tripeptide building block for solid-phase synthesis of sterically hindered or sterically constrained therapeutic peptides.
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Key side-chain fatty acid linker used in the chemical synthesis of long-acting GLP-1 receptor agonist peptides such as Semaglutide and Tirzepatide.
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Protected tetrapeptide fragment critical for the synthesis of novel metabolic and incretin mimetic peptide drugs under high purity standards.
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Crucial dipeptide derivative containing alpha-aminobutyric acid (Aib) to prevent enzymatic cleavage in peptide therapeutic candidates.
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Pivotal lipidated lysine derivative utilized for half-life extension chemistry in peptide-based therapeutics.
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Addressing key technical, regulatory, and logistics queries for Hungarian biopharmaceutical buyers.
Partner with Gentolex Group for premium cGMP active pharmaceutical ingredients, reliable supply chain security, and expert EU regulatory guidance.