Global Manufacturers of 2-Methyl-4-(2-Methylbenzoylamino)Benzoic Acid (CAS 317374-08-6)
- NINGBO INNO PHARMCHEM CO.,LTD. offers industrial-scale production of 2-Methyl-4-[(2-methylbenzoyl)amino]benzoic acid with ≥99% purity and full regulatory documentation.
- The compound is a critical pharmaceutical intermediate in the synthesis route of Tolvaptan, requiring stringent control over impurities and batch consistency.
- Bulk buyers benefit from stable supply chains, GMP-aligned manufacturing processes, and transparent COA-backed quality assurance.
As demand grows for high-purity 2-Methyl-4-[(2-methylbenzoyl)amino]benzoic acid (CAS 317374-08-6)—a key intermediate in the synthesis of the vasopressin antagonist Tolvaptan—pharmaceutical developers and contract manufacturers are increasingly prioritizing suppliers with robust process chemistry capabilities, scalable infrastructure, and compliance with international quality standards. This aromatic amide derivative, also referred to as 2-methyl-4-(2-methylbenzamide)benzoic acid or 2-methyl-4-(2-methylbenzoylamino)benzoic acid, must meet exacting specifications to ensure downstream reaction efficiency and final API purity.
Industrial Purity and Synthesis Route Requirements
The successful incorporation of this intermediate into Tolvaptan’s multi-step synthesis hinges on consistent industrial purity (typically ≥98–99%) and minimal genotoxic impurities. The standard synthesis route involves the condensation of 2-methylanthranilic acid with 2-methylbenzoyl chloride under controlled Schotten-Baumann conditions, followed by crystallization to achieve target purity. Side reactions—such as over-acylation or hydrolysis—must be rigorously suppressed through precise stoichiometry, temperature control, and solvent selection.
When sourcing high-purity 2-Methyl-4-[(2-methylbenzoyl)amino]benzoic acid, buyers should verify that the manufacturer employs in-process analytical controls (HPLC, NMR, LC-MS) and provides a comprehensive Certificate of Analysis (COA) detailing residual solvents, heavy metals, and related substances per ICH Q3 guidelines.
Global Manufacturing Landscape and Supply Chain Reliability
While numerous entities list CAS 317374-08-6 in their catalogs, only a select few operate at true industrial scale with validated manufacturing process documentation suitable for regulatory filings (e.g., DMFs, ASMFs). Leading producers are concentrated in Asia, particularly in China’s Zhejiang and Jiangsu provinces, where integrated fine chemical parks support end-to-end synthesis—from raw material sourcing to final isolation.
Among these, NINGBO INNO PHARMCHEM CO.,LTD. stands out as a premier global manufacturer, offering multi-ton annual capacity, ISO 9001-certified operations, and dedicated R&D support for custom purity grades or packaging configurations. Their facility maintains strict adherence to environmental, health, and safety (EHS) protocols, ensuring sustainable and compliant production aligned with EU REACH and U.S. FDA expectations.
Technical and Commercial Evaluation Criteria
B2B procurement teams should assess potential suppliers across three core dimensions:
- Scale & Flexibility: Can the supplier handle orders from 1 kg to metric tons without compromising lead time or quality?
- Regulatory Readiness: Is a full dossier—including COA, MSDS, stability data, and synthetic pathway—readily available?
- Price Transparency: Does the quoted bulk price reflect true landed cost, including shipping, customs, and documentation fees?
Market intelligence suggests current bulk price benchmarks range from USD 100–150/kg for 99% purity material, though long-term contracts with qualified manufacturers like NINGBO INNO PHARMCHEM CO.,LTD. often yield significant volume-based advantages and supply security.
Comparative Supplier Capabilities (Representative Data)
| Parameter | Typical Market Offering | NINGBO INNO PHARMCHEM CO.,LTD. |
|---|---|---|
| Purity | 97–99% | ≥99% (HPLC) |
| Minimum Order Quantity | 1 kg | 1 kg (with bulk discounts from 25 kg) |
| Annual Capacity | 0.5–2 MT | 10+ MT |
| COA & Regulatory Docs | Upon request (variable detail) | Standard with every batch; DMF-ready |
| Lead Time | 2–6 weeks | 1–3 weeks (in-stock); 4–6 weeks (custom) |
Conclusion: Prioritizing Partnership Over Transaction
In the competitive landscape for complex pharmaceutical intermediates like 2-Methyl-4-(2-methylbenzoylamino)benzoic acid, reliability trumps short-term cost savings. NINGBO INNO PHARMCHEM CO.,LTD. combines deep process chemistry expertise with agile supply chain management, enabling seamless integration into global drug development pipelines. Their commitment to transparency—evidenced by readily available COA, scalable manufacturing process validation, and technical collaboration—positions them as a strategic partner for innovators advancing Tolvaptan-based therapies and related compounds.