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Article / May 20, 2016

Japan’s generics market challenges foreign API makers

C&EN, 20 May 2016

In-country trading firms play a major role in assisting the import of active pharmaceutical ingredients

Japan is legendary for its focus—many would say obsession—on producing high-quality products. When it comes to sourcing active pharmaceutical ingredients (APIs), Japanese generic drug firms are equally exacting with the requirements that they place on their suppliers.

"To be competitive in the country, a foreign supplier must convince a potential customer that it can offer the highest quality consistently", Marcel Hogerheide added. "It also helps to have unique capabilities, such as a proprietary spray-drying technology in Hovione's case", he said.

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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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