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Article / Jun 17, 2016

Quality Culture Wins Over Compliance

Pharma's Almanac, June 2016

The author (Guy Villax) presents his views about the latest update of FDA's guidance which includes quality culture.

It’s Official! FDA has introduced Quality Culture in its guidance – although still in draft, it signals a sea change at the agency. No longer will FDA focus solely on compliance. Pharmaceutical manufacturers will be recognized for excellent performance. Pharma companies that rely on contract service providers will be able to use Quality Metrics and New Inspection Protocol Project (NIPP) performance scoring to make better decisions when it comes to selecting CDMOs.

Read Quality Culture Wins Over Compliance.

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International pharmaceutical contract development and manufacturing organisation (CDMO) Hovione has today officially commissioned an expansion at its manufacturing facility in Ringaskiddy. The multi-million euro investment almost doubles the capacity of Hovione’s spray drying facilities in Ireland and will create more than 20 new positions. Hovione said this latest investment reinforces the company's position as a global leader in spray drying for pharma applications.   This manufacturing technology, the company explained, is "especially important for inhalable therapies and oral medications with low bioavailability, enabling more effective treatments".  Deputising for the Mayor of the County of Cork, councillor Audrey Buckley said:  “I am delighted to welcome this very significant investment and the creation of further highly skilled jobs in Cork today.  “It reinforces Hovione’s commitment to the region and the innovative solutions it provides to the pharmaceutical industry in Ireland.” Meanwhile Michael McGrath, the European Commissioner-Designate for Democracy, Justice and the Rule of Law, welcomed the expected jobs boost the expansion is to create.  “This latest investment highlights the success of Hovione’s facility in Ringaskiddy, and underlines the continued resilience of Ireland’s pharmaceutical manufacturing sector.  “I am delighted that Hovione will be shortly welcoming new team members to this expanded facility, and I wish both them and Hovione every success”. Jean-Luc Herbeaux, Hovione's chief executive said: “This newly opened facility further strengthens Hovione's position as the global CDMO of choice for spray drying development and manufacturing services.  “It also underscores our commitment to bringing first-in-class technology and world-leading manufacturing services to Irish shores.  “Ireland provides a superior environment for pharmaceutical manufacturing, and we are delighted to be a part of it.” CEO of IDA Ireland, Michael Lohan, said Hovione "has made a significant contribution both locally and nationally through employment and investment alike". "We warmly welcome Hovione’s commitment to investing in Cork and we wish them continued success," he added.    Read the full article on EchoLive.ie    

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EchoLive, 25 November 2024

Pharma company announces expansion of Cork facility to create more than 20 new jobs

Nov 25, 2024

Pharmaceutical contract development and manufacturing company Hovione has officially commissioned an expansion at its manufacturing facility in Ringaskiddy, Cork.  Announcing the development on Monday, the multi-million euro investment almost doubles the capacity of Hovione’s spray drying facilities in Ireland and will create more than 20 new positions. This manufacturing technology is especially important for inhalable therapies and oral medications with low bioavailability, enabling more effective treatments, the company said. Deputising for the Mayor of the County of Cork, Cllr. Audrey Buckley said: “I am delighted to welcome this very significant investment and the creation of further highly skilled jobs in Cork today.  "It reinforces Hovione’s commitment to the region and the innovative solutions it provides to the pharmaceutical industry in Ireland.”  Michael McGrath, the European Commissioner-Designate for Democracy, Justice and the Rule of Law said: “This latest investment highlights the success of Hovione’s facility in Ringaskiddy, and underlines the continued resilience of Ireland’s pharmaceutical manufacturing sector. "I am delighted that Hovione will be shortly welcoming new team members to this expanded facility, and I wish both them and Hovione every success”. This latest investment builds on the momentum of the recently announced spray drying capacity expansion at the Company's East Windsor, New Jersey, site.  Jean-Luc Herbeaux, Hovione´s Chief Executive said: “This newly opened facility further strengthens Hovione´s position as the global CDMO of choice for spray drying development and manufacturing services.  "It also underscores our commitment to bringing first-in-class technology and world-leading manufacturing services to Irish shores. Ireland provides a superior environment for pharmaceutical manufacturing, and we are delighted to be a part of it.” IDA chief executive Michael Lohan said the company has made a significant contribution both locally and nationally, adding: "I am pleased to be here today to mark another step on that journey. We warmly welcome Hovione’s commitment to investing in Cork and we wish them continued success.”   Read the full article on IrishExaminer.com  

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Irish Examiner, 25 November 2024

Pharma company Hovione to double capacity at Cork site as part multi-million euro investment

Nov 25, 2024

Hovione’s Eunice Costa Shares Insights on Inhaled Medicine Formulation in Pharmaceutical Technology eBook The demand for efficient inhalation therapies is higher than ever. At Hovione we are focusing on particle size, dispersion performance, and formulation integrity to ensure optimal bioavailability and patient outcomes.  To learn more about or work, do not miss the contribution of Eunice Costa, our R&D Director for Inhalation & Advanced Drug Delivery, in the latest Pharmaceutical Technology eBook – “Trends in Formulation”.  In her interview, Eunice discusses key challenges and considerations in formulating inhaled medicines, emphasizing the importance of excipient selection, device compatibility, and patient-centric design for successful drug delivery to the lungs. With respiratory diseases at the forefront, especially following the COVID-19 pandemic, the demand for efficient inhalation therapies is higher than ever. Eunice sheds light on how Hovione is tackling these demands by focusing on particle size, dispersion performance, and formulation integrity to ensure optimal bioavailability and patient outcomes. Explore Eunice Costa’s full insights on this crucial area of drug development in Pharmaceutical Technology's September 2024 eBook. This resource provides an in-depth look into the complexities of inhaled drug formulations and the exciting innovations shaping the future of respiratory treatments.   Read the full article at Pharmaceutical Technology eBook Read the Trends in Formulation eBook at PharmTech  

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Excipient and delivery device selection play crucial roles in the formulation of inhaled drugs.

Formulating Inhaled Medicines

Sep 24, 2024

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