At a Glance
Your Trusted CDMO Partner
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Global Clients
100+
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Employees
4,900+
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Global Regulatory
Approvals
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Total Capacity
604 kL + Plant 5 *
Plant 1
30,000 L
Plant 2
154,000 L
Plant 3
180,000 L
Plant 4
240,000 L
Plant 5
180,000 L *
* To be operational in April 2025
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 CDMO Leadership Awards for 12 consecutive years.
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 : 38
EMA : 12
FDA : 9
Total : 59
- 2020
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Others : 64
EMA : 15
FDA : 15
Total : 94
- 2021
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Others : 107
PMDA : 0
EMA : 19
FDA : 17
Total : 143
- 2022
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Others : 165
EMA : 25
FDA : 24
Total : 214
- 2023
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Others : 219
EMA : 31
FDA : 30
Total : 280
- 2024
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Others : 263
EMA : 36
FDA : 41
Total : 340
- 2025
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Others : 267
EMA : 37
FDA : 44
Total : 348
| Number of Approvals | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA | 1 | 3 | 4 | 8 | 9 | 15 | 17 | 24 | 30 | 41 | 44 |
| EMA | 4 | 5 | 7 | 12 | 15 | 19 | 25 | 31 | 36 | 37 | |
| Others (PMDA, MFDS, and etc.) |
4 | 8 | 38 | 64 | 107 | 165 | 219 | 263 | 267 | ||
| Cumulative Total | 1 | 7 | 13 | 23 | 59 | 94 | 143 | 214 | 280 | 340 | 348 |
