cGMP
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Manufacturing
American Peptide is a supplier of peptides and related products for therapeutic and diagnostic human studies in HIV, osteoporosis, diabetes, Alzheimer's, and many other human disease states.
Demonstrated Manufacturing under cGMP
Strict Compliance with cGMP and ICH Guidelines Guarantees Quality Products.
GMP manufacturing facilities, procedures, and documentation are maintained in
accordance with current Good Manufacturing Practice as described in the United
States Code of Federal Regulations and International Conference on Harmonization (ICH) Guidance Q7 for Active Pharmaceutical Ingredients (API drug substances).
| Synthetic Peptide Manufacturing Facility Our 34,000 square feet (3,160 square meters) cGMP facility is designed for large scale peptide synthesis. Our facility has capacity to synthesize gram to multi-kilogram quantities of peptides for diagnostic research, pre-clinical, tox studies, clinical phase I, II and III trials, and commercial FDA approved products. |