Remove 2002 Remove Compounding Remove Vaccines
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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Published 2002. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally.

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A history of Pfizer

pharmaphorum

It was at this time they set their site at Sandwich in the UK, initially just to finish processing compounds imported from America, but due to tariffs on imported products the company rapidly expanded the plant to accommodate producing medicines from scratch. Likewise, tanezumab, an anti-osteoarthritic, failed in trials.