Pheniramine Maleate
CAS No.: 132-20-7
Synonym: Avil
Mol. Formula: C₂₀H₂₄N₂O₄
Mol. Weight: 356.42 g/mol
ATC Code: R06AB04
Therapeutic Category: Antihistamine
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
Pheniramine Maleate API Brazil is manufactured with strict quality controls to ensure high purity, defined particle size, and consistent assay values. Each batch undergoes analytical testing for identity, related substances, moisture content, and stability. Advanced synthesis and purification processes maintain uniformity, while GMP-aligned operations ensure compliance with international pharmacopeial standards. The API is suitable for antihistamine formulations, including tablets, syrups, and injectables, with controlled impurity profiles to support long-term safety and efficacy in final dosage forms.

2) Comprehensive Documentation
Documentation for Pheniramine Maleate API includes a complete DMF, COA, MSDS, stability data, and regulatory support files required for global submissions. Manufacturing records, validation protocols, and impurity data are meticulously maintained to meet regional regulatory norms. Technical packages include analytical methods, residual solvent reports, and packaging information, ensuring complete transparency and readiness for audits or product registration in multiple markets.

3) Secure Supply Chain
A robust supply chain ensures the timely availability of Pheniramine Maleate API through qualified raw material vendors, controlled logistics, and validated storage conditions. Temperature-controlled warehousing, batch traceability, and real-time monitoring reduce risks of delays, contamination, or supply disruption. End-to-end planning supports uninterrupted demand for local and international pharmaceutical manufacturers.

4) Manufacturer & Supplier Expertise
Experienced chemists and process engineers optimize the scalable production of Pheniramine Maleate API with consistent output. Expertise in industrial synthesis, regulatory compliance, and global distribution ensures superior manufacturing performance. Continuous process improvements enhance yield, stability, and quality reliability for diverse market needs.

5) Amber Lifesciences’ Role
Amber Lifesciences offers high-quality Pheniramine Maleate API with GMP-certified production, stringent QC systems, and reliable global supply. The company supports clients with flexible batch sizes, documentation assistance, and dependable technical support, ensuring efficient sourcing and smooth regulatory approvals.

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