The number of Certificates of Suitability of Monographs of the European Pharmacopoeia (CEPs) globally grew steadily between 2000 and 2023, from 589 to over six thousand (total number). CEPs are proof of an active pharmaceutical ingredient's quality, and are used for drug approvals worldwide. In the U.S., the equivalent to the CEP would be the Drug Master File (DMF), submitted to the Food and Drug Administration. This statistic illustrates the number of valid CEPs from 2000 to 2023.
Number of valid certificates (CEPs) for active pharmaceutical ingredients quality worldwide from 2000 to 2023
Characteristic
Number of CEPs
2023*
6,310
2022*
5,997
2020*
5,400
2018
3,888
2016
3,719
2014
3,372
2012
3,024
2010
2,554
2008
2,063
2006
1,661
2004
1,294
2002
929
2000
589
01,0002,0003,0004,0005,0006,0007,000
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All valid CEPs (Certificates of Suitability of Monographs of the European Pharmacopoeia) in the respective calendar year for the APIs under consideration. Does not include expired or withdrawn CEPs. * Total number of valid CEPs. 2020 figure is a rounded estimate.
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MundiCare, & Pro Generika. (May 31, 2024). Number of valid certificates (CEPs) for active pharmaceutical ingredients quality worldwide from 2000 to 2023 [Graph]. In Statista. Retrieved April 21, 2025, from https://www.statista.com/statistics/1181576/global-ceps-number-development-for-apis/
MundiCare, und Pro Generika. "Number of valid certificates (CEPs) for active pharmaceutical ingredients quality worldwide from 2000 to 2023." Chart. May 31, 2024. Statista. Accessed April 21, 2025. https://www.statista.com/statistics/1181576/global-ceps-number-development-for-apis/
MundiCare, Pro Generika. (2024). Number of valid certificates (CEPs) for active pharmaceutical ingredients quality worldwide from 2000 to 2023. Statista. Statista Inc.. Accessed: April 21, 2025. https://www.statista.com/statistics/1181576/global-ceps-number-development-for-apis/
MundiCare, and Pro Generika. "Number of Valid Certificates (Ceps) for Active Pharmaceutical Ingredients Quality Worldwide from 2000 to 2023." Statista, Statista Inc., 31 May 2024, https://www.statista.com/statistics/1181576/global-ceps-number-development-for-apis/
MundiCare & Pro Generika, Number of valid certificates (CEPs) for active pharmaceutical ingredients quality worldwide from 2000 to 2023 Statista, https://www.statista.com/statistics/1181576/global-ceps-number-development-for-apis/ (last visited April 21, 2025)
Number of valid certificates (CEPs) for active pharmaceutical ingredients quality worldwide from 2000 to 2023 [Graph], MundiCare, & Pro Generika, May 31, 2024. [Online]. Available: https://www.statista.com/statistics/1181576/global-ceps-number-development-for-apis/
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