Pharmaceutical API Manufacturer for US — Product Catalog & Specifications

Pharmaceutical API Product Catalog for US Buyers

As the world’s largest pharmaceutical market, US requires a diverse range of pharma APIs for pharmaceutical manufacturing, compounding, and formulation. This comprehensive product catalog covers our full range of pharma raw materials available for export to US.

Our product range includes metformin, atorvastatin, amoxicillin, omeprazole, losartan, all manufactured under WHO GMP conditions and supplied with complete FDA-compliant documentation.

Product Categories: Pharmaceutical APIs Available for US

Injectable Pharmaceutical APIs

Our injectable-grade pharma APIs meet the highest purity standards required for parenteral formulations. Key features include:

• Purity ≥99.5% by HPLC for injectable grades
• Endotoxin levels below 0.5 EU/mg
• Sterility tested per USP <71> methods
• Particle size controlled per customer specifications
• Available in 1 kg, 5 kg, 10 kg, and 25 kg packaging

Oral Grade Pharmaceutical APIs

For tablet, capsule, and suspension formulations, our oral-grade pharma APIs offer:

• Purity ≥99.0% by HPLC
• Controlled particle size distribution for optimal dissolution
• Polymorphic form characterized and documented
• Stability data available per ICH guidelines
• Excipient compatibility studies available on request

Pharmaceutical Intermediates

We also supply pharma intermediates for US-based manufacturers who perform final synthesis in-house. Our intermediates portfolio includes key building blocks for metformin, atorvastatin, amoxicillin, omeprazole, losartan.

Manufacturing & Quality Standards

Our pharma API manufacturing facility operates under:

• WHO GMP certification — Internationally recognized quality standards
• ISO 9001:2015 — Quality management system certification
• ICH Q7 compliance — API manufacturing best practices
• Dedicated pharma production lines — Preventing cross-contamination
• Full analytical laboratory — In-house HPLC, IR, UV-Vis, and dissolution testing

Specifications & Documentation for US

Every pharma API shipped to US through major US ports of entry includes:

• Batch-specific Certificate of Analysis (COA)
• HPLC chromatograms and impurity profiles
• Certificate of Pharmaceutical Product (CPP)
• WHO GMP certificate
• MSDS and handling guidelines
• FDA import documentation support

Custom Pharmaceutical API Manufacturing

For US buyers with specific requirements, we offer custom pharma API manufacturing services including:

• Custom particle size and polymorphic form
• Modified purity specifications
• Private labeling and custom packaging
• Scale-up from R&D to commercial production
• Process development and optimization

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Request a quote: Contact Aarise Pharma for pharma API specifications, pricing, and samples delivered to US.