Apextide successfully completed the GMP inspection by the FDA

Apextide, a subsidiary of Sinopep underwent a five-day inspection by the FDA from October 28 to November 1, 2024. We have recently received the FDA's Establishment Inspection Report, confirming that we have successfully completed this GMP inspection. 

In 2022, Sinopep expanded its interdisciplinary focus into the field of gene therapy by establishing its subsidiary, Apextide. Building upon our existing expertise for small molecules and peptides, this expansion into oligonucleotides realises cross-platform synergies for efficient and cost-competitive production.

This achievement makes Sinopep one of very few enterprises to have completed FDA Inspection in the small molecule, peptide, and oligonucleotide fields simultaneously. It also signifies that Sinopep and its subsidiaries' quality management systems meet the FDA's stringent cGMP requirements, earning recognition from international pharmaceutical regulatory agencies and marking a significant milestone in the company's development.