At a Glance
Your Trusted CDMO Partner
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Global Clients
145+
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Employees
5,800+
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Global Regulatory
Approvals
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Total Capacity
845 kL
Plant 1
30,000 L
Plant 2
155,000 L
Plant 3
180,000 L
Plant 4
240,000 L
Plant 5
180,000 L
U.S. Facility
60,000 L
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 13 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 : 3
EMA : 5
FDA : 4
Total : 12
- 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 : 65
EMA : 15
FDA : 14
Total : 94
- 2021
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Others : 104
PMDA : 0
EMA : 19
FDA : 16
Total : 139
- 2022
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Others : 164
EMA : 25
FDA : 23
Total : 212
- 2023
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Others : 219
EMA : 31
FDA : 29
Total : 279
- 2024
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Others : 270
EMA : 36
FDA : 40
Total : 346
- 2025
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Others : 319
EMA : 50
FDA : 52
Total : 421
- 2026
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Others : 345
EMA : 59
FDA : 60
Total : 464
| Number of Approvals | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA | 1 | 3 | 4 | 8 | 9 | 14 | 16 | 23 | 29 | 40 | 52 | 60 |
| EMA | 4 | 5 | 7 | 12 | 15 | 19 | 25 | 31 | 36 | 50 | 59 | |
| Others (PMDA, MFDS, and etc.) |
3 | 8 | 38 | 65 | 104 | 164 | 219 | 270 | 319 | 345 | ||
| Cumulative Total | 1 | 7 | 12 | 23 | 59 | 94 | 139 | 212 | 279 | 346 | 421 | 464 |
