Steroid API Manufacturer for Mexico — Product Catalog & Specifications

Steroid API Product Catalog for Mexico Buyers

As Latin America’s largest pharmaceutical market, Mexico requires a diverse range of steroid APIs for pharmaceutical manufacturing, compounding, and formulation. This comprehensive product catalog covers our full range of steroid raw materials available for export to Mexico.

Our product range includes testosterone, corticosteroids, anabolic steroids, prednisolone, dexamethasone, all manufactured under WHO GMP conditions and supplied with complete COFEPRIS-compliant documentation.

Product Categories: Steroid APIs Available for Mexico

Injectable Steroid APIs

Our injectable-grade steroid 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 Steroid APIs

For tablet, capsule, and suspension formulations, our oral-grade steroid 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 steroid intermediates for Mexico-based manufacturers who perform final synthesis in-house. Our intermediates portfolio includes key building blocks for testosterone, corticosteroids, anabolic steroids, prednisolone, dexamethasone.

Manufacturing & Quality Standards

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

Specifications & Documentation for Mexico

Every steroid API shipped to Mexico through Manzanillo and Veracruz includes:

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

Custom Steroid API Manufacturing

For Mexico buyers with specific requirements, we offer custom steroid 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

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

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