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News & Conferences

Apextide successfully completed the GMP inspection by the FDA

发布时间：

2025-03-06

Apextide 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 realizes cross-platform synergies for efficient and cost-competitive production.

This achievement signifies that Apextide's 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.

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