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Another challenge is the global supply chain management of APIs. Many pharmaceutical companies rely on outsourcing API production to countries with lower manufacturing costs, like India and China. While this practice can reduce costs, it also exposes companies to risks such as supply disruptions, quality control issues, and geopolitical factors. In recent years, the COVID-19 pandemic underscored these vulnerabilities, prompting many companies to seek local production options or diversify their suppliers.


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Companies involved in the production of pharmaceutical intermediates must adhere to Good Manufacturing Practices (GMP). This involves maintaining detailed records of manufacturing processes, conducting regular quality checks, and ensuring traceability of raw materials and intermediates throughout the production cycle. Compliance with these regulations not only helps in maintaining product quality but also protects the manufacturers from legal and financial liabilities.


 

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