Press Room

The use of spray drying in the pharmaceutical industry is growing at a fast pace. The need for robust scale-up methods is essential in order to control critical quality attributes and improve powder properties during drug development. Moreover, poor scale-up is likely to lead to considerable losses of expensive materials. Process understanding and simulation is a very powerful tool to support the scale-up of spray drying processes. A scale-up methodology based on scientific principles is proposed in this study. The method is divided in two steps: thermodynamic and atomization & particle formation. The method is relatively straightforward to apply and has been tested in numerous spray-dried formulations across all production scales. An illustrative example is also shown covering the main steps of the proposed methodology. Read article here

Article
Chemistry Today, July/August 2010

Scale-up methodology for pharmaceutical spray drying

Jul 31, 2010

Loures, Portugal, July 28th, 2010 - Hovione announced today that the consolidated sales for the fiscal year ended March 31st 2010 amounted to USD144m, representing an increase of 15% over the previous year. During 2009 Hovione celebrated its 50th Anniversary at everyone of its facilities. The Company acquired an API manufacturing facility from Pfizer, in Cork, Ireland, as well as a state-of-the-art Aseptic Spray Drying (ASD) manufacturing line. Hovione also expanded its production capacity of contrast agents at the Hisyn site in China. ASD capability is core to our strategy and Hovione is committed to remaining the global industry leader in spray drying. The plant in Cork doubled Hovione’s quality production capacity and will enable to capture new market opportunities. “This is proof of our commitment to providing our customers with assured continuity of supply and the highest standards”, said Guy Villax, Chief Executive Officer. “Another year of continued strong performance by the Hovione group. During the last five years Hovione has increased sales by 77%, has gone from three to five industrial plants and has passed the 1000 Team Members mark. Looking forward, and despite the difficult economic environment, we remain confident that 2010 will be another year of solid growth”, adds Miguel Calado, Chief Financial Officer.” About Hovione Hovione is an international company with 51 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on the most demanding customers, in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services. For further information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release
Sales reach USD 144 million for the fiscal year ended March 31st 2010.

Hovione’s sales grow 15%

Jul 28, 2010

Loures, Portugal, July 21, 2010. Hovione is announcing the nomination of two of its scientists to the United States Pharmacopeia (USP), for the period 2010-2015. Jason Suggett, PhD has been named to the General Chapters – Dosage Forms Expert Committee and Nuno Matos is joining the Chemical Analysis Expert Committee. Jason Suggett joins as an expert in the field of inhalation products and will contribute his knowledge in the area of new testing procedures for inhalation products. Nuno Matos is an expert in the field of process analytical technology (PAT), near-infrared spectroscopy and chemometrics. Peter Villax, Vice-President said “Hovione has been active in the standard setting process for three decades now. We are delighted that two of our scientists are joining USP committees, and hope that their work brings a significant contribution, particularly in the areas of PAT and inhalation.” The USP is a non-governmental, official public standards-setting authority responsible for overseeing standards for prescription medicines and other healthcare products manufactured or sold in the United States. USP's activities have a significant impact on promoting quality and protecting the public health worldwide. About Hovione Hovione is an international company with 51 years’ experience in Active Pharmaceutical Ingredient development and compliant manufacture, from molecule to unit dose. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on serving the most demanding customers in the most regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.   For further information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release

Hovione scientists bring PAT and inhalation expertise to USP

Jul 21, 2010

Counterfeit medicines are an acknowledged crisis that takes patient risk to unacceptable levels – the authors argue that this is but the visible part of the iceberg. Counterfeit APIs are the much larger submerged part of the iceberg. Counterfeit APIs are a more serious issue as it represents a threat to the integrity of the legal supply chain of medicines, it potentially impacts a much larger number of patients and European and Japanese authorities do not yet perceive it as a threat – as such they may well remain outside the scope of proposed falsified medicines legislation and enforcement objectives. The pharmaceutical industry and its supply chain appear alone at taking steps to address this criminal threat. Read article here

Article
Chemistry Today, July/August 2010 (Supplement)

Who is making the Pharmaceutical Supply Chain safe?

Jul 01, 2010

Custom manufacturers take on drug solubility issues to help pharmaceutical firms move products through development When they get together, pharmaceutical researchers call drug compounds by nicknames such as “brick dust” and “grease.” Whether compounds are crystalline rocks, lipophilic goo, or something in between, getting them to be water soluble can be a major hurdle for making therapies bioavailable in the body. If the bioavailability is low, meaning only a fraction of a dose gets into circulation, even the best molecule can fail as a drug. About 40% of marketed drugs are thought to be poorly water soluble. Development efforts might have to be redoubled, however, because between 70 and 90% of drug candidates in the pipeline are believed to have low solubility. In fact, solving solubility problems is considered to be the leading challenge in drug development. Read article here

Article
C&EN, 31 May, 2010

Finding Solutions

May 31, 2010

Drug manufacturer Hovione has opened a new spray drying facility in Loures, Portugal, for potent active ingredients. Marco Marques, head of production, describes the safety protocols. Pharmaceutical contract manufacturer Hovione has recently received a significant number of new spray drying projects with special containment requirements. The company’s answer to this market demand has been to install a new spray dryer unit in a dedicated manufacturing suite at its site in Loures, Portugal. The facility design allows the handling of potent compounds up to class III, according to independent health & safety consultant SafeBridge, and it complies fully with good manufacturing practices (GMP) as required by international drug authorisation bodies. Read full article

Article
Cleanroom Technology, May 2010

Handling potent drug materials

May 31, 2010

Advances in drug formulation and inhalation device design are creating new opportunities for inhaled drug delivery as an alternative to oral and parenteral delivery methods. Much of the interest in pulmonary delivery of systemic drug therapies is focused on chronic diseases and refractory conditions, ailments that require frequent drug administration for a protracted period of time. Read article here

Article
Drug Delivery Technology, April 2010

Inhalation: Going Beyond Asthma. Interview: Peter Villax and Jason Suggett

Apr 30, 2010

“It is much harder to be in this business today than it was five or 10 years ago,” admits Hovione Chief Executive Officer Guy Villax. Although Villax believes that having a clear strategy is increasingly fundamental to success, he admits that “it’s quite tough and requires much better thinking to come up with the value proposition that you present to your customers.” Read article here

Article
C&EN, 8 February, 2010

Custom Chemicals. After struggling through 2009, contract manufacturers are honing their strategies and hoping for a better 2010

Feb 08, 2010

Loures, Portugal, February 2, 2010. Hovione is announcing the filing of a New Drug Application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione’s TwinCaps® inhaler. Being pre-filled, disposable and low-cost, TwinCaps® was specifically developed for the influenza indication and may thus be used for inhaled drug delivery to the lung in other acute indications, such as bacterial or viral infections. Since the inhaler was designed for a primarily inhaler-naive population, ease of use was the most important design criterion. Patents for TwinCaps® were filed worldwide in 2006 and have already been issued in Japan, South Africa and Portugal. Hovione expects the case to proceed to grant in all jurisdictions. CS-8958 is a laninamivir prodrug, a long-acting neuraminidase inhibitor developed as an inhaled drug by Daiichi Sankyo for the Japanese market. Clinical studies performed with adults and children suffering from type A or B influenza viruses have proven that the delivery of CS-8958 by TwinCaps® is effective with a single treatment course. Daiichi Sankyo have also announced the start of a Phase III clinical trial to demonstrate efficacy in influenza prevention. Hovione has licensed its inhalation device patents to Daiichi Sankyo and Biota Holdings Ltd (Victoria, Australia) and collaborated on the formulation development. Peter Villax, Vice-President in charge of TwinCaps® development, said “This filing follows four years of great collaboration between Daiichi Sankyo and Hovione and we are very honoured to be part of this project”. For further information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications (Isabel Pina, + 351 21 982 9362, e-mail: hello@hovione.com)    

Press Release

Hovione’s TwinCaps® dry-powder inhaler filed in Japan for the treatment of influenza

Feb 02, 2010

Loures, Portugal, September 29th, 2009 – Hovione's API plant in Loures, Portugal has just successfully passed a pre-approval inspection by FDA. The inspection, carried out by Mr. Mark Parmon, Inspector of Cincinnati District lasted 5 days as initially planned, starting on 21st September and concluded on the 25th, covering 5 ANDAs and 1 NDA. No Form 483 was issued. At the closing meeting the inspector informed that he was happy with what he had seen and congratulated our GMP System and the knowledge of team members. Luisa Paulo, Hovione's Compliance Director, said "The inspection focused on the documentation system, especially on how we record and manage OOS, deviations, change control, batch production records and analytical procedures. The Inspector focused on looking for deviations in consistency of the application of procedures”. Hovione plants have been the object of 17 FDA inspections, with 10 at the Loures site since 1982. The thoroughness of inspections and the ability to make an assessment of the maturity of GMP system is far greater than before. The main objective of this inspection was to evaluate how the “guidelines and internal procedures” are followed in day-to-day plant operations. Special emphasis was given to: 1) root cause determination; 2) preventive and corrective actions implementation and follow-up; 3) impact analysis of the changes and 4) production and analytical operation. The Loures plant has a total workforce of about 500 professionals and produces both generic products, as well as APIs and bulk formulated products manufactured under exclusivity for both clinical trials and for commercial sale. The facility exports to the most demanding markets such as North America, EU, Japan and Australia. About Hovione. Hovione is an international company with 50 years’ experience in active pharmaceutical ingredient development and compliant manufacture. With four FDA inspected sites in the US, China, Ireland and Portugal the company focuses on the most demanding customers in the most highly regulated markets. The company also offers integrated API, particle design and formulation development and manufacturing. In the inhalation area Hovione is the only independent company offering such a broad range of services. For more information about Hovione, please visit the Hovione site at www.hovione.com or contact Corporate Communications, Isabel Pina, + 351 21 982 9362, e-mail: mailto:hello@hovione.com.    

Press Release

Successful FDA inspection at Hovione’s API manufacturing plant in Loures, Portugal

Sep 29, 2009

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