Document Type

Article

Rights

Available under a Creative Commons Attribution Non-Commercial Share Alike 4.0 International Licence

Disciplines

Pharmacology and pharmacy

Abstract

Purpose This paper aimed to analyze the situation of the biopharmaceutical industry in Saudi Arabia to improve the situation in a way that achieves high levels of development similar to those in Europe, the United States of America (USA), and Japan. Methods To achieve the objective of the study, the authors surveyed 18 out of 21 Saudi pharmaceutical companies that have received licensing for manufacturing from the Saudi Food and Drug Authority (SFDA) to diagnose the situation of manufacturing in relation to biopharmaceuticals. An interview with SFDA officials was carried out as a supplement to the survey. Results Findings revealed a serious lack of manufacturing of biopharmaceuticals in Saudi Arabia. In addition, knowledge of biopharmaceutical practice in upstream and downstream bioprocessing is poor. The analysis of interviews revealed some progress in biopharmaceuticals in Saudi Arabia, namely, applications to manufacture insulin and vaccines. Conclusion On the basis of the findings, recommendations were made to develop the situation of biopharmaceutics in Saudi Arabia.

DOI

https://doi.org/10.1007/s12247-020-09429-1

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