Hormone API Manufacturer for US — Product Catalog & Specifications

Hormone API Product Catalog for US Buyers

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

Our product range includes testosterone cypionate, HGH, levothyroxine, estradiol, progesterone, all manufactured under WHO GMP conditions and supplied with complete FDA-compliant documentation.

Product Categories: Hormone APIs Available for US

Injectable Hormone APIs

Our injectable-grade hormone 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 Hormone APIs

For tablet, capsule, and suspension formulations, our oral-grade hormone 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 hormone intermediates for US-based manufacturers who perform final synthesis in-house. Our intermediates portfolio includes key building blocks for testosterone cypionate, HGH, levothyroxine, estradiol, progesterone.

Manufacturing & Quality Standards

Our hormone 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 hormone production lines — Preventing cross-contamination
• Full analytical laboratory — In-house HPLC, IR, UV-Vis, and dissolution testing

Specifications & Documentation for US

Every hormone 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 Hormone API Manufacturing

For US buyers with specific requirements, we offer custom hormone 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

Related Products & Guides

• Steroid API Supplier for US
• Peptide API Supplier for US
• Pharmaceutical API Supplier for US
• Hormone API Supplier for Mexico
• Hormone API Supplier for Peru
• Hormone API Supplier for Paraguay

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