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However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).
However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Research (OPIR).
2 However, most of these efforts relating to catalysis, 3 process waste metrics, 4 lifecycle assessments, 5 pharmaceuticals in the environment 6 and the phase out of substances of concern 7 mainly mitigate the consequences of pharmaceuticalmanufacturing. Environ Sci Technol 2018, 52, 4, 1725–1734 [link].
In addition to standards for active pharmaceutical ingredients, USP also develops standards for the inactive ingredients (excipients) and other raw materials used in drug manufacturing. In a 2019 report on drug shortages, the FDA found that 62% of drug shortages occur because of quality issues in manufacturing.
Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceuticalmanufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018. Edge Biologicals Inc.,
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