Inosine Pranobex
CAS No.: 36703-88-5
Synonym: Isoprinosine
Mol. Formula: C₁₀H₁₂N₄O₅ · C₅H₉NO₂ · C₅H₁₃NO₂
Mol. Weight: 670.73 g/mol
ATC Code: J05AX05
Therapeutic Category: Antiviral
DMF Available: Yes
COA Available: Yes
FDA Approved: Yes
API Grade: IP/BP/USP
WHO GMP Approved: Yes

1) API Quality
High-quality Inosine Pranobex API in Italy is critical for ensuring therapeutic efficacy and patient safety, particularly in treating viral infections and supporting immune modulation. Quality is maintained through strict adherence to GMP standards, validated manufacturing processes, and rigorous in-process controls. Parameters such as purity, potency, impurity profile, and stability are closely monitored to ensure batch-to-batch consistency. Only APIs meeting pharmacopoeial and regulatory specifications are suitable for pharmaceutical formulations.

2) Comprehensive Documentation
Complete documentation is essential for regulatory compliance and global market access. This includes Drug Master Files (DMFs), analytical method validation reports, stability studies, process validation data, and impurity profiling. Transparent and accurate documentation ensures traceability, facilitates product registration, and supports audits by regulatory authorities efficiently.

3) Secure Supply Chain
A secure supply chain guarantees uninterrupted availability of Inosine Pranobex API. Manufacturers maintain controlled sourcing of raw materials, proper storage conditions, and anti-counterfeit measures. Efficient logistics, temperature-controlled transport, and risk management protocols minimize disruptions and ensure timely delivery to pharmaceutical partners worldwide.

4) Manufacturer & Supplier Expertise
Expertise in complex chemical synthesis, regulatory compliance, and scale-up processes is vital. Experienced manufacturers provide technical guidance, customized specifications, and reliable long-term supply. This reduces formulation challenges, ensures compliance with global pharmaceutical standards, and supports successful market distribution.

5) Amber Lifesciences’ Role
Amber Lifesciences serves as a trusted partner by sourcing high-quality Inosine Pranobex API, ensuring comprehensive documentation, and maintaining a secure supply chain. Their technical expertise, commitment to quality, and regulatory compliance make them a dependable supplier for pharmaceutical manufacturers globally.

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