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In the contemporary landscape of targeted oncology therapies, Brigatinib (CAS No. 1197953-54-0) stands out as a potent, second-generation selective tyrosine kinase inhibitor (TKI). Specifically designed to target anaplastic lymphoma kinase (ALK) mutations and resistance mutations such as ROS1 and EGFR variations, Brigatinib has transformed clinical outcomes for patients suffering from non-small cell lung cancer (NSCLC).
As patent cliffs approach and global healthcare providers demand cost-effective, high-purity generic alternatives and finished dosage formulations (FDF), the role of a certified OEM Brigatinib Company becomes paramount. Global pharmaceutical markets require strict adherence to international regulatory frameworks, flawless chemical reproducibility, and highly resilient supply chain infrastructure.
Bridging global healthcare demands with guaranteed, cGMP-grade active pharmaceutical ingredients, custom synthesis, and complete contract manufacturing services.
Gentolex operates an overall factory construction area exceeding 250,000 square meters constructed under rigid international standards. This infrastructure offers scalable, flexible, and cost-effective solutions for small-batch research formulations up to metric-ton commercial synthesis.
With satisfied partners spanning more than 10 countries, Gentolex Group has established active regional support centers and official representatives in strategic markets, including Mexico and South Africa, ensuring localized regulatory and logistics coordination.
Our operational framework focuses on supplying Peptide APIs and Custom Peptides, FDF License-Out programs, specialized technical support & consulting, state-of-the-art laboratory and production line setups, and customized procurement services.
High-grade industrial, fine chemical intermediates, and synthetic raw materials scaled efficiently.
cGMP APIs and intermediates backed by complete DMF, CEP, and regional regulatory documentation.
Proprietary process chemistry, analytical method validation, and custom peptide synthesis optimization.
Turnkey supply chain consolidation eliminating multi-vendor complexities for global pharmaceutical buyers.
Scientific rigor, advanced crystalline structure optimization, and strict impurity limits define our OEM chemical synthesis capabilities.
Brigatinib is chemically designated as 5-chloro-N2-(4-(4-(dimethylphosphoryl)piperazin-1-yl)-2-methoxyphenyl)-N4-(2-(dimethylphosphoryl)phenyl)pyrimidine-2,4-diamine. Its distinct structural characteristic features a rare phosphine oxide moiety, which significantly improves target affinity while maintaining systemic metabolic stability.
| Parameter | Specification Standard |
|---|---|
| Chemical Name | Brigatinib (AP26113) |
| CAS Registry Number | 1197953-54-0 |
| Molecular Formula | C29H39ClN7O2P |
| Molecular Weight | 584.09 g/mol |
| Assay (HPLC) | 99.0% – 101.0% (Anhydrous Basis) |
| Individual Impurity | ≤ 0.10% (ICH Q3A Compliant) |
| Heavy Metals | ≤ 10 ppm |
| Physical Form | Off-white to pale yellow crystalline powder |
As a leading OEM partner, Gentolex utilizes an optimized, multi-step convergent synthetic route that guarantees high overall yields while minimizing dangerous side reaction byproducts:
Synthesis of the key dimethylphosphoryl aniline intermediate under robust inert gas protection to avoid oxidation defects.
Controlled regioselective substitution of 2,4,5-trichloropyrimidine ensuring maximum yield of the targeted isomer.
Attachment of the 4-(dimethylphosphoryl)piperazine tail followed by specialized crystallization protocols to yield Form A polymorphic stability.
Navigating global regulatory landscapes requires comprehensive technical documentation. Gentolex provides full support for pharmaceutical registrations across jurisdictions including the FDA (USA), EMA (Europe), NMPA (China), and ANVISA (Brazil).
In addition to API supply, Gentolex provides finished dosage form (FDF) contract manufacturing for Brigatinib in standard solid oral dosages (30mg, 90mg, and 180mg film-coated tablets).
We offer complete dossier packages in CTD format, facilitating rapid regulatory submission and localized market launches for brand holders.
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View DetailsKey technical, regulatory, and commercial insights for pharmaceutical procurement teams regarding OEM Brigatinib.
Gentolex manufactures the thermodynamically stable Form A polymorph of Brigatinib API. This polymorph is thoroughly characterized using X-ray Powder Diffraction (XRPD) and Differential Scanning Calorimetry (DSC) to ensure robust dissolution profiles and stable shelf life in final tablet dosage forms.
Our chemical synthesis route isolates potential impurities at intermediate stages. All final active pharmaceutical ingredients undergo rigorous testing via Headspace GC-MS to ensure residual solvents comply strictly with ICH Q3C limits. Genotoxic impurities are controlled below TTC (Threshold of Toxicological Concern) levels.
Yes, our contract manufacturing (OEM/ODM) services cover full formulation development. We offer finished oral tablets (30mg, 90mg, 180mg) with custom blister packaging, bottle packaging, and complete private labeling backed by complete batch production records (BPR).
Standard commercial batches of catalog APIs are available for dispatch within 5 to 10 business days. Custom OEM synthesis or specialized batch sizes typically require 4 to 8 weeks depending on analytical method validation and custom parameter requirements.
Gentolex operates regional offices and authorized representatives in Mexico and South Africa. This allows us to manage end-to-end cold-chain logistics, customs clearance, import documentation, and localized client assistance smoothly without administrative delays.
Explore our complete commercial portfolio across oncology, endocrinology, metabolic therapies, and industrial fine chemicals.
