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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

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).

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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

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).

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World Standards Day: Recognizing How Standards Enable a Strong Medicines Supply Chain

Quality Matters

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.

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Building CO2-neutral, defossilised supply chains for chemicals

European Pharmaceutical Review

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 pharmaceutical manufacturing. Environ Sci Technol 2018, 52, 4, 1725–1734 [link].

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FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers 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.,