At a Glance Your Trusted CDMO Partner
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Employees
4400 +
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Total Capacity
604KL*
* Upon P4 completion in 2023 -
Inspections
86
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Global Clients
100 +
- Global Regulatory Approvals
- Awards
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By consistently delivering superior client satisfaction through execution excellence and innovation, Samsung Biologics has been selected by our clients for
the CMO Leadership Awards for nine consecutive years.


- CMO LEADERSHIP AWARDS 2022
- CMO LEADERSHIP AWARDS 2022 CAPABILITIES
- CMO LEADERSHIP AWARDS 2022 COMPATIBILITY
- CMO LEADERSHIP AWARDS 2022 EXPERTISE
- CMO LEADERSHIP AWARDS 2022 QUALITY
- CMO LEADERSHIP AWARDS 2022 RELIABILITY
- CMO LEADERSHIP AWARDS 2022 SERVICE
Global Regulatory Approvals
- 2015
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FDA : 1
Total : 1
- 2016
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EMA : 4
FDA : 3
Total : 7
- 2017
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Others : 4
EMA : 5
FDA : 4
Total : 13
- 2018
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Others : 8
EMA : 7
FDA : 8
Total : 23
- 2019
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Others : 37
EMA : 12
FDA : 9
Total : 58
- 2020
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Others : 63
EMA : 15
FDA : 15
Total : 93
- 2021
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Others : 98
PMDA : 0
EMA : 19
FDA : 18
Total : 135
- 2022
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Others : 147
EMA : 25
FDA : 25
Total : 197
- 2023
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Others : 148
EMA : 25
FDA : 27
Total : 200
Number of Approvals | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 |
---|---|---|---|---|---|---|---|---|---|
FDA | 1 | 3 | 4 | 8 | 9 | 15 | 18 | 25 | 27 |
EMA | 4 | 5 | 7 | 12 | 15 | 19 | 25 | 25 | |
Others (PMDA, MFDS, and etc.) |
4 | 8 | 37 | 63 | 98 | 147 | 148 | ||
Cumulative Total | 1 | 7 | 13 | 23 | 58 | 93 | 135 | 197 | 200 |