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Conclusion


Both API and formulation development face numerous challenges. One significant challenge is the inherent variability in biological systems, which can affect how drugs perform in patients. Additionally, regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) impose rigorous standards that drug developers must meet to ensure product safety and efficacy.


Another challenge is the complex nature of the pharmaceutical supply chain. The pandemic highlighted vulnerabilities in global supply chains, particularly for APIs. Disruptions can result in shortages of critical medications, necessitating a reevaluation of sourcing and manufacturing strategies. Many companies are now prioritizing the development of local manufacturing capabilities to mitigate these risks.


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3. Omega-3 Fatty Acids


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