Honours and Qualifications

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Factory Qualification
113.4 kL
Total Capacity
200+
Clients
900+
Employees
100
Global Regulatory Approvals
Brand Introduction Management Team Milestones Qualifications

History of Audits and Inspections

20 On-site Inspection by Chinese Regulatory Authorities
6 EU Qualified Person (QP) Audit
250+ Customer and Third-Party Audits
·Data as of May 26, 2026

Global Regulatory Approvals

97 Clinical approvals
3 Commercialization approvals
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Number of Approvals 2019 2020 2021 2022 2023 2024 20252026
NMPA 1 3 8 20 38 50 6061
FDA 0 1 2 8 12 22 2627
Others 1 1 2 4 7 8 99
Cumulative Total 2 5 12 32 57 80 9597
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