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A Report On Fine Chemicals

Decent Essays
Fine Chemicals Is API manufacturing returning to Europe? Shannon Bennett of Thomson Reuters takes a look at the shifts in active ingredient sourcing During the past decade, as manufacturers have pursued lower costs and a more favourable regulatory environment, API sourcing has expanded from regulated into less regulated markets. However, sourcing from emerging markets has revealed a variety of challenges which pharmaceuticals companies are continuously working to overcome. These challenges, coupled with increasing costs in India and China and demand for specialised technologies, could steer some companies to return to sourcing their APIs from European suppliers. Regulatory developments Interest in the pursuit of the US generic drugs market…show more content…
The European Generics Association (EGA) recently requested consideration of an EU Bolar Export Provision. This would allow EU generic drugs companies to develop and manufacture products specifically for export to the global market without breaching existing EU patent protection. Such a provision would not only benefit EU companies by levelling the API playing field but would also facilitate the entry and availability of generic drugs in 'pharmerging ' markets, where the only available option may be more expensive branded drugs. The future of EU API manufacturing could be influenced by the outcome of other pending initiatives that would require more from companies in terms of investment in and oversight of suppliers. For example, the adoption of the EU 's Falsified Medicines Directive requires the verification of all finished dose packs throughout the supply chain, as well as for APIs exported to EU, proving they were produced within quality specifications equivalent to those in EU. Source: Robert Pollack, Lachman Consultants Figure 1 - GDUFA fees An additional requirement has been proposed which would require API manufacturers to verify the source of all starting materials, ensuring that they originated from the facilities claimed by the manufacturer of the starting materials. This could help EU manufacturers, as sourcing from European companies would require less paperwork and oversight than sourcing from India and China. Additionally, European companies may choose
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