High-purity siRNA and ASO active pharmaceutical ingredients customized for pharmaceutical formulators, research institutes, and commercial drug developers across Buenos Aires, Rosario, and Córdoba.
Navigating the Latin American biopharmaceutical sector requires deep regulatory intelligence, local market integration, and unwavering chemical precision.
Argentina represents one of Latin America's most sophisticated pharmaceutical manufacturing hubs, driven by strong domestic formulation capabilities in Buenos Aires Province, Santa Fe, and Córdoba. As healthcare demands shift toward targeted genetic therapeutics, cardiovascular management (PCSK9 targeting via Inclisiran), and rare metabolic diseases (porphyria management via Givosiran), local biopharma enterprises are rapidly expanding their nucleic acid pipelines. Gentolex provides the raw material security and high-purity chemical bases required to support both clinical trials and commercial production throughout the MERCOSUR region.
Compliance with ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is paramount for importing and utilizing Active Pharmaceutical Ingredients in Argentina. Gentolex supplies complete technical regulatory packages, including Drug Master Files (DMF) in CTD format, Certificates of Analysis (CoA) validated by HPLC/MS, residual solvent analysis (ICH Q3C), elemental impurity profiles (ICH Q3D), and microbiological sterility validation. Our documentation ensures smooth customs clearance through Ezeiza Airport (EZE) and expedited local ANMAT drug registration.
Gentolex has established optimized cold-chain transport networks (-20°C to -80°C validated shipping containers) specifically configured for Argentina's seasonal ambient fluctuations. By offering localized logistics support and flexible batch sizes from analytical gram-scale to multi-kilogram cGMP commercial batches, we remove traditional import bottlenecks for South American biomanufacturers.
State-of-the-art Solid-Phase Oligonucleotide Synthesis (SPOS) paired with proprietary GalNAc conjugation methodologies.
Our proprietary tri-antennary N-Acetylgalactosamine (GalNAc) conjugation chemistry delivers exceptional hepatocyte-targeting specificity via asialoglycoprotein receptors (ASGPR). This technology underpins high-efficacy therapeutics such as Inclisiran and Zilebesiran, allowing dramatic dose reduction and extended therapeutic intervals for cardiorenal targets.
Utilizing advanced phosphoramidite building blocks, automated synthesis column optimization, and precise backbone modification (2'-O-methyl, 2'-fluoro, phosphorothioate linkages), Gentolex guarantees ultra-low deletion sequence levels and superior nuclease stability across all RNAi and ASO molecules.
Purification is conducted using multi-stage Ion Exchange Chromatography (IEX) and Hydrophobic Interaction Chromatography (HIC), followed by tangential flow filtration (TFF). Endotoxin control is strictly maintained below 0.05 EU/mg, meeting stringent parenteral formulation criteria required by ANMAT and international pharmacopeias.
Gentolex’s goal is to create opportunities connecting the world with better biopharmaceutical services and guaranteed active raw products. Up to date, Gentolex Group has been serving customers across more than 10 countries, with specialized international logistics infrastructure and dedicated representative hubs established in key global markets including Mexico and South Africa.
Our main services focus on supplying standard and modified peptide APIs, Custom Peptides, Oligonucleotides, Finished Dosage Form (FDF) licensing out, Technical Support & Regulatory Consultation, Complete Product Line and Lab Setup, as well as integrated Global Sourcing & Supply Chain Solutions.
250,000 m² combined factory construction under cGMP/WHO standards offering flexible, scalable, and cost-effective batch outputs.
Extensive portfolio of peptide and oligonucleotide APIs and advanced intermediates for preclinical development, clinical trials, and commercial manufacturing.
Single-point contact procurement services eliminating supply chain fragmentation for South American pharmaceutical buyers.
Explore our full line of ultra-pure peptides, metabolic active ingredients, specialized intermediates, and diagnostic compounds engineered for international commercial distribution.
Latest scientific advancements, analytical reviews, and application notes from our Global R&D Team.
Selank Acetate API is a synthetic heptapeptide (Thr-Lys-Pro-Arg-Pro-Gly-Pro) derived from endogenous tuftsin. Explore our scaled peptide synthesis routes and quality metrics tailored for neuropharmacological development.
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As a leading global supplier, Gentolex delivers high-purity Thymosin Beta-4 raw materials designed for tissue repair, cell migration research, and biopharmaceutical formulations demanding rigorous sterility controls.
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Detailed synthesis insights for BPC-157 API. Highlighting amino acid sequence purity, HPLC chromatograms, mass spectrometry verification, and stable lyophilization protocols for international transport.
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Investigating ACTH-fragment analogue Semax. Analysis of sequence stability, aqueous storage degradation, and cGMP compliance parameters required for clinical-grade bulk active ingredients.
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SS-31 (MTP-131 / Bendavia) binds cardiolipin in the inner mitochondrial membrane to stabilize bioenergetics. Technical specs and custom peptide production timelines from Gentolex facilities.
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Answers to common regulatory, logistical, and technical queries from Argentine pharmaceutical manufacturers and procurement specialists.
Gentolex provides comprehensive regulatory assistance, providing complete Drug Master Files (DMF) structured in CTD format, batch-specific Certificates of Analysis (CoA), TSE/BSE risk declarations, residual solvent documentation under ICH Q3C, and stability testing data (accelerated and long-term according to ICH Q1A). Our regulatory team works directly with your local ANMAT submission representatives to guarantee seamless clearance.
Each oligonucleotide batch undergoes stringent analytical testing including High-Performance Liquid Chromatography (RP-HPLC & IE-HPLC) for purity determination (>98.5%), Electrospray Ionization Mass Spectrometry (ESI-MS) or MALDI-TOF for exact molecular weight confirmation, Karl Fischer titration for water content, endotoxin testing via LAL assay (<0.05 EU/mg), and heavy metal content via ICP-MS.
Lyophilized oligonucleotide APIs are packaged in light-resistant, air-tight glass vials inside temperature-controlled insulation containers. Depending on the product sensitivity, we utilize temperature-monitored dry ice (-78.5°C) or validated cold gel packs (-20°C) with real-time data loggers. Shipments routed through Ezeiza International Airport (EZE) receive priority customs handling to prevent temperature excursions.
Yes. Gentolex operates advanced custom synthesis platforms capable of incorporating specialized modifications such as GalNAc conjugation, 2'-O-Methyl (2'-OMe), 2'-Fluoro (2'-F), phosphorothioate (PS) backbone linkages, cholesterol conjugation, and terminal fluorescent tags. Synthesis spans from milligram research quantities to multi-kilogram cGMP commercial batches.
Standard catalog items (such as Inclisiran Sodium, Linaclotide, or Retatrutide) in stock are dispatched within 3-5 business days following QA release. Express international air freight to Argentina typically requires 5 to 8 days transit. Custom synthesis orders require 4 to 8 weeks depending on sequence complexity, modification type, and batch scale.
Partner with Gentolex for cGMP-grade Oligonucleotides and Peptide APIs. Request pricing, batch chromatograms, and technical DMF documentation today.
