GMP-Audited Manufacturing Network
Every manufacturing partner in our network undergoes a rigorous 6-step qualification process including on-site GMP audits, regulatory verification, and APICOA sample testing before producing a single batch for distribution.
How We Qualify Manufacturing Partners
A 6-step qualification process ensures every manufacturing partner meets pharmaceutical-grade standards before joining our network.
Facility Audit
Comprehensive on-site GMP audit evaluating manufacturing processes, quality systems, documentation practices, equipment calibration, and personnel training. Audits are conducted by qualified assessors following ICH Q7 guidelines.
Regulatory Verification
Verification of all regulatory certifications including GMP certificates, manufacturing licenses, environmental permits, and Drug Master File (DMF) registrations with relevant health authorities.
Capability Assessment
Technical evaluation of synthesis capabilities, analytical equipment (HPLC, LC-MS, GC-MS), process development expertise, and production capacity for API and peptide manufacturing.
Quality System Review
Deep review of the manufacturer's quality management system including SOPs, deviation handling, CAPA processes, change control, batch record documentation, and stability programs.
Sample Testing
Initial qualification batches are tested by APICOA for identity, purity, potency, and contaminants. Results must meet or exceed predefined acceptance criteria before supplier approval.
Approved Supplier Status
Manufacturers meeting all qualification criteria are added to the approved supplier list with defined scope (products, quantities, markets). Ongoing monitoring and periodic re-audits maintain status.
Manufacturing Capabilities
Our partner network provides comprehensive API manufacturing from chemical synthesis through peptide production to custom contract manufacturing.
API Chemical Synthesis
Multi-step organic synthesis of small molecule active pharmaceutical ingredients using GMP-validated processes with full analytical characterization.
Peptide Synthesis
Solid-phase and liquid-phase peptide synthesis (SPPS/LPPS) for therapeutic peptides including BPC-157, TB-500, and custom sequences up to 50 amino acids.
Custom Manufacturing
Contract manufacturing services for custom API development, process scale-up from lab to production, and technology transfer for proprietary compounds.
Analytical Testing (In-House)
In-process testing and release testing using HPLC, GC, Karl Fischer, particle size analysis, and spectroscopic methods. Results documented in batch records.
Production Scale
Manufacturing capacity ranges from gram-scale R&D batches to multi-kilogram commercial production with validated scale-up protocols.
Export Preparation
Complete export documentation including Certificates of Origin, packing lists, MSDS, and temperature-controlled packaging for international shipment.
GMP Standards We Require
All manufacturing partners must demonstrate compliance with these pharmaceutical manufacturing standards.
ICH Q7 Compliance
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients — the international standard for API manufacturing quality systems.
WHO GMP Certification
World Health Organization GMP certification demonstrating compliance with internationally recognized pharmaceutical manufacturing standards.
HPLC & Batch Documentation
Complete batch records with HPLC chromatograms, in-process controls, environmental monitoring data, and deviation documentation for every production batch.
Equipment Qualification
All critical manufacturing and analytical equipment undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Personnel Training
Manufacturing personnel are trained on GMP principles, SOPs, contamination control, and documentation practices with regular competency assessments.
Stability Programs
ICH-compliant stability studies (accelerated and long-term) establish shelf life, storage conditions, and retest dates for all manufactured APIs.
Source from GMP-Qualified Manufacturers
Every API in our catalog comes from a qualified, GMP-audited manufacturing partner with independent APICOA Verified\u2122 testing.