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Article / Jun 01, 2007

Enforcing GMP compliance for APIs in EU medicines

Pharmaceutical Technology Europe, June 2007

The legal basis for APIs for the EU market to be manufactured under GMP — a requirement already in place in the US since the 1970s — was created through a directive adopted in March 2004. Health authorities in the EU are now gradually increasing their enforcement efforts and are training their inspectors to check for GMP compliance of APIs used in medicines marketed in the EU. In November 2006, a majority in the EU Parliament voted in favour of an important ‘Written Declaration’ that proposes that only GMP-certified APIs will be allowed in EU medicines.

The Active Pharmaceutical Ingredients Committee (APIC) — a sector...

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Every year, the largest bank in Portugal, Caixa Geral de Depósitos recognizes some of Portugal’s brightest young minds through the Caixa +Mundo Awards, providing nearly €800,000 in scholarships to students as they pursue higher education. In this year´s edition, Caixa named the award bestowed upon students pursuing science for Diane Villax. This prestigious honor places Diane Villax among the award’s namesakes – a distinguished group of prominent personalities who have made notable contributions to Portugal´s socio-economic, cultural, political and scientific development over the last 50 years, such as António Ramalho Eanes, Mário Soares, José Saramago, Sophia de Mello Breyner, Leonor Beleza, Elvira Fortunato, Rui Nabeiro, Américo Amorim, and José Manuel de Mello. Diane Villax will also honor the seven scientific award winners by personally meeting with each of them, and following their journeys as future innovators and leaders. But this honor is about far more than one individual. It is a celebration of an entire organization and the people behind it. For 67 years, generations of dedicated teams have worked together with passion, purpose, and excellence to manufacture life-saving medicines and advance science that has a real impact on people. This recognition belongs to all of us.    

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Prestigious Caixa +Mundo Award named in honor of Diane Villax

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CDMO Hovione and Industrial Design Consultancy (IDC) have announced that their new single-use capsule-based nasal delivery device is now available exclusively as part of an integrated platform that includes Hovione’s intranasal drug development and manufacturing services. The companies partnered in 2023 with plans for development of two capsule-based devices for intranasal delivery: the single-use device and a multidose device. Read the full article at OINDPnews.com      

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Hovione and IDC announce new single-use capsule-based intranasal delivery device for dry powder formulations

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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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