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Article / Jul 01, 2006

What Is Next for Suppliers to the European Union?

Pharmaceutical Technology Sourcing and Management, July 2006

Global API Sourcing: What Is Next for Suppliers to the European Union?

The authors discuss the preparedness of European regulatory authorities to implement and enforce the recent EU Directives 2004/27 and 2004/28, which require that all medicines marketed in the EU be made with active pharmaceutical ingredients (APIs) that comply with the harmonized GMP standard ICH/Q7A.

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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