High-purity commercial active pharmaceutical ingredients, protected amino acids, and custom peptide building blocks produced under strict cGMP compliance.
The global therapeutic peptide market is undergoing an unprecedented paradigm shift, transitioning from niche metabolic applications into mainstream biopharmaceutical dominance. As targeting precision, synthetic yields, and oral delivery capabilities expand, demand for robust, high-volume, and cGMP-compliant active pharmaceutical ingredients (APIs) has intensified. China has established itself as the primary engine for global peptide raw material manufacturing, supported by world-class chemical synthesis infrastructure, scalable solid-phase/liquid-phase technologies, and cost-effective regulatory integration.
Beyond metabolic therapeutics, peptide-drug conjugates (PDCs), cyclic antimicrobial peptides, and neuroactive oligopeptides (e.g., Selank, Semax) are driving double-digit annual growth rates. Modern pharmaceutical buyers demand not only cost efficiency but absolute quality assurance, verifiable enantiomeric purity, controlled impurity profiles (single unknown impurity < 0.10%), and full traceability under ICH Q7 standards.
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.
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.
End-to-end custom peptide synthesis (SPPS/LPPS), novel amino acid modifications, isotope labeling, target sequence design, and yield optimization from milligram to multi-kilogram batches.
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.
Industrial peptide synthesis requires meticulous chemical controls to prevent racemization, aggregation, and truncated byproduct formation. Our state-of-the-art manufacturing facilities leverage automated high-throughput Solid-Phase Peptide Synthesis (SPPS) alongside cost-efficient Liquid-Phase Peptide Synthesis (LPPS) hybrid strategies.
Intramolecular and intermolecular disulfide bridging (e.g., in Eptifibatide, Pegcetacoplan, and protected disulfide intermediates) is controlled through selective orthogonal protecting groups (e.g., Acm, Trt, Mob). Controlled oxidation using iodine or air-bubbling protocols yields consistent tertiary structures, preventing misfolded isomers and preserving biological activity.
Long-acting therapeutic peptides utilize side-chain acylation to bind serum albumin, extending circulating half-life. Our production platform excels at multi-step synthesis of specialized linkers such as Ste-γ-Glu-AEEA-AEEA-OSU and protected lysine intermediates like Fmoc-Lys(Pal-Glu-OtBu)-OH, guaranteeing high coupling yields (>98%) and low impurity profiles.
Take a closer look at our 250,000 square meter standardized production base, cleanrooms, and worldwide strategic hub connections.
Stay informed with technical whitepapers, molecule profiles, and regulatory updates from Gentolex’s analytical 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...
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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 li...
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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 ac...
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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 due to its unique mol...
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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, SS-31 ha...
View DetailsExpert responses regarding custom peptide manufacturing, cGMP compliance, quality documentation, and international shipping protocols.
Every production batch undergoes comprehensive analytical release testing, including High-Performance Liquid Chromatography (HPLC) for purity (>98% or >99%), Liquid Chromatography-Mass Spectrometry (LC-MS) for mass identity verification, Amino Acid Analysis (AAA) for peptide content quantification, Residual Solvent Determination via GC-Headspace, Water Content (Karl Fischer), Heavy Metals analysis (ICP-MS), and Bacterial Endotoxin testing (LAL assay). Complete Certificates of Analysis (COA) are included with each batch.
Gentolex offers full regulatory support, including Drug Master File (DMF) documentation, US FDA cGMP compliance validation, ASMF (Active Substance Master File) for European authorities, and ICH Q1A-Q1F stability study data. Our regulatory affairs team assists clients during IND/NDA registration processes, providing FDF licensing out and audit-ready site validation documentation.
Our synthesis capabilities include complex side-chain modifications (acylation, PEGylation, biotinylation, phosphorylation), non-natural amino acid incorporation (D-amino acids, Aib, N-methyl amino acids), cyclic peptide formation (head-to-tail, side-chain to side-chain, mono-/multi-disulfide bridges), and peptide-conjugate linkers (such as Ste-γ-Glu-AEEA-AEEA-OSU).
Temperature-sensitive lyophilized peptides and liquid intermediates are packaged using validated insulated cold-chain shipping containers with temperature monitoring data loggers (-20°C or +2°C to +8°C). Through our established international distribution network—including key logistics centers and regional representations in Mexico and South Africa—we ensure rapid, compliant customs clearance and seamless transit.
Explore our broader catalogue of therapeutic APIs, metabolic peptide derivatives, protected reagents, and fine chemical catalysts.
