Metoclopramide Hydrochloride
CAS No.: 54143-57-6
Synonym: Reglan, Maxolon
Mol. Formula: C₁₄H₂₂ClN₃O₂
Mol. Weight: 299.80 g/mol
ATC Code: A03FA01
Therapeutic Category: Antiemetic
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
High-quality Metoclopramide Hydrochloride API in Thailand is vital for ensuring efficacy and safety in antiemetic and gastroprokinetic formulations. Quality is maintained through strict adherence to GMP standards, validated synthesis protocols, and rigorous in-process testing. Parameters such as purity, potency, stability, and absence of impurities are carefully monitored to ensure consistent batch-to-batch performance. Only APIs that meet pharmacopeial and regulatory standards are suitable for formulation.

2) Comprehensive Documentation
Comprehensive documentation supports regulatory compliance and smooth global distribution. This includes Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), process validation reports, stability studies, and impurity profiling. Transparent and accurate documentation facilitates traceability, product registration, and auditing by regulatory authorities efficiently.

3) Secure Supply Chain
A secure supply chain ensures uninterrupted availability of Metoclopramide Hydrochloride API. Manufacturers implement controlled sourcing of raw materials, proper storage conditions, robust risk management, and efficient logistics to ensure timely delivery. This minimizes supply disruptions for pharmaceutical partners worldwide.

4) Manufacturer & Supplier Expertise
Expertise in chemical synthesis, regulatory compliance, and process scale-up is critical. Experienced manufacturers provide technical guidance, customized specifications, and reliable long-term supply, ensuring consistent quality for pharmaceutical applications.

5) Amber Lifesciences’ Role
Amber Lifesciences is a trusted supplier of Metoclopramide Hydrochloride API, offering high-quality product, secure supply chain, comprehensive documentation, and expert technical support. Their commitment to quality and compliance makes them a dependable partner for global pharmaceutical manufacturers.

Active Pharmaceutical Ingredient (API) – Not for Direct Human or Veterinary Use.