Press Room

According to Life Science Leader magazine, in the 2017 CMO Leadership Awards, Hovione exceeded customers expectations in the Compatibility and Accessible Senior Management categories. These awards recognize the leading contract manufacturing organizations. Find more about Hovione in each compatibility category topic: Access to desired markets Accessible senior management Complementary core competencies to in-house or other manufacturing contractors Cultural Fit Financial strength/stability Timely project communications     CMO Leadership Awards website

News
Hovione recognized in the 2017 CMO Leardership Awards

2017 CMO Leadership Award

Mar 22, 2017

Hovione, an established Portuguese pharmaceutical company, has opened a representative office in Osaka in June 2016 and now established Hovione K.K. in February 2017. The company has been engaged in R&D and manufacturing of drug ingredients and compounds for more than 50 years since its foundation in 1959. Its strength lies in its expertise and advanced technology in areas such as inhalation development. It has expanded manufacturing sites in the US, Macau and Ireland. In Japan, Hovione distributes their Active Pharmaceutical Ingredients (API) for generic drugs to major pharmaceutical companies via sales agents, and it is also engaged in contracted development and manufacturing development as well as the particle engineering. Hovione plans to apply for a license of Marketing Authorization Holder (MAH) and to obtain additional sales approval of its API. For the establishment of Hovione’s base in Japan, the JETRO Invest Japan Business Support Center (IBSC) provided support such as consultation (corporate registration, labor affairs and tax matters) and invitation to Japan to assist the establishment of the base. JETRO   ポルトガルの製薬会社Hovioneが大阪に進出 ポルトガルに本社を置く、老舗製薬会社であるHovione が2016年6月、大阪に日本駐在員事務所を開設し、 2017年2月にホビオン株式会社を設立した。 同社は、1959年の創業以来50年以上にわたり、原薬や化合物の研究開発と製造を行っており、特に吸入剤などの分野で高い技術を持っている。海外では、米国、マカオ、アイルランドにも製造工場を保有。日本では、代理店経由で大手製薬会社を対象に主にジェネリック医薬品（後発薬）向け原薬販売を行っているほか、受託開発製造、粒度設計などにも従事している。 今後は日本法人の医薬品製造販売認可や日本で販売する原薬の追加承認申請等を進めていく。 日本拠点設立に際し、ジェトロ対日投資・ビジネスサポートセンター（IBSC）は、拠点設立にかかるコンサルテーション（登記・労務・税務）、個別招へい等支援を行った。 JETRO / ジェトロ

Article
JETRO, March 17, 2017

Hovione establishes presence in Osaka

Mar 17, 2017

Expanding the Commercial Options for Preparation of Amorphous Solid Dispersions Spray drying (SD) and hot-melt extrusion (HME) are commercially proven and accepted amorphous solid dispersion (ASD) technologies for the enhancement of the dissolution and bioavailability of poorly soluble drugs. These approaches are not suitable for all APIs, however. Hovione, in addition to offering non-ASD solutions such as nanomilling and cyclodextrin complexation, is developing an effective coprecipitation technology platform to address this key market need.   Read the full article

Article
Pharma's Almanac, Q1 2017, Mar 8, 2017

Expanding the Commercial Options

Mar 08, 2017

This article covers examining key strategies for solubility and dissolution assessment of new drug products, drug product intermediates and APIs. There must be an initial stage where the API properties are well studied and the impact of these properties on solubility and dissolution are assessed. Supersaturation studies are very important in this initial stage to help establishing drug concentrations used during method development and to help selecting the best formulation during polymer screening. The next step should get to know better solubilization strategies and the effective concentration of drug substance based on the most physiologically relevant methods. Based on the knowledge acquired during the biorelevant screening methodologies, a faster and reliable QC method suitable for daily routine and release purposes should then be developed.    Read the full article    

Article
ContractPharma, March 7, 2017

Know Your Drug: A Solution to Dissolution

Mar 07, 2017

Last Sunday, I had the opportunity to attend the St. Martens party (in Portuguese ‘Magusto’) at the Hovione premises in Taipa. For those who do not know Hovione, it is a corporation with a manufacturing plant in Macau and premises in eight other locations, from Lisbon to New Jersey, and in Mainland China, India, Japan, Hong Kong, and Ireland. Driven by the vision of its CEO, Mr. Guy Villax, it has expanded hugely over the last two decades. It is also the reason why you read this column here in Macau. As a matter of fact, in early 2012 I was placed in Macau by the then ICEP (Portuguese external trade agency) now AICEP. Truth be told, it is one of the sole examples of diversification of the economy in Macau.   Read the entire article at Macau Business  

Article
Macau Business, November 18, 2016

A True Diversifier

Nov 18, 2016

Former Lonza executive signed the first contract and wrote the book   Riding in a minibus back to Manhattan from Hovione’s East Windsor, N.J., technology center in 2003, I felt slightly overwhelmed. Having taken on the pharmaceutical chemicals beat at C&EN, I needed guidance on why a family-owned company from Portugal needed a technology center in New Jersey. The man in the seat in front of me turned around to ask me what I thought of the Hovione venture. This would be the first of many discussions . . .

Article
C&EN, November 7, 2016

The fine chemicals sector remembers Peter Pollak

Nov 07, 2016

There is growing demand for dry-powder inhalation formulations of drugs to treat both respiratory and systemic diseases. Composite particle technology is allowing the development of more efficient formulations, even for challenging molecules. Spray drying is an  enabling technology for composite particle preparation. Formulators must be aware, however, of the tradeoffs between properties that improve aerodynamic performance in the lung but negatively impact  process yields or throughputs. Read the entire text

Article
Pharma's Almanac, Q4 2016, October 23, 2016

Dry-Powder Inhalation Formulation: Balancing Performance and Manufacturability

Oct 23, 2016

During 2016 CPhI Worldwide, Hovione was recognised as the API Supplier of the Year with a Global Generics & Biosimilars Award. This award recognises Hovione for its achievements over the preceding 12 months and was judged by a panel of industry experts. The Global Generics & Biosimilars Awards 2016 ceremony is presented by the Generics bulletin and it was held in Barcelona on 4 October 2016.                 Find more about Hovione's Off-Patent API products    

News
Hovione receives Global the Generics & Biosimilars Award 2016 in the category of API Supplier of the Year.

Hovione is the API Supplier of the Year

Oct 04, 2016

by Guy Villax Rx-360 has no home country; it was designed from day one to be global, to welcome all organizations from all nations and all cultures. Our member companies have sales that add up to half a trillion dollars, supply close to half of the world’s prescription drugs and come from all the major countries. Rx-360 is active not just in the developed world... Read the full article or visit Pharma's Almanac.

Article
Pharma's Almanac, October 2016

Rx-360: An Industry Group Like No Other

Oct 01, 2016

Contract development and manufacturing organizations with unique technical capabilities and expertise are able to speed up the development and commercialization of novel medicines. Effective application of its extensive knowledge, data base and Development by Design approach has enabled Hovione to accelerate spray drying development, simultaneously reducing cost and time to get challenging drugs to patients in need. Read "Accelerating approval and reducing costs of spray dried drugs through development by design" article

Article
Pharma's Almanac, Global Pharmaceutical Supply Chain Trends, Q3 2016

Accelerating approval and reducing costs of spray dried drugs through development by design

Aug 30, 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.

Article
Pharma's Almanac, June 2016

Quality Culture Wins Over Compliance

Jun 17, 2016

Loures, Portugal, June 15, 2016 – Hovione announced today that it held on June 8th the official groundbreaking for the expansion of its New Jersey facility in East Windsor, USA. The expansion will add an additional 30,600 ft² (2,843 m²) to the existing 24,000ft² (2,211m²) facility. It will introduce a new commercial spray dryer unit to complement the existing pilot unit and this installation will be specifically designed to handle potent drug substances (APIs). In addition the Hovione New Jersey facility will more than double its capacity to manufacture drug substance. The expansion is expected to add approximately 60 new jobs to the current workforce over the next three years. “The start of the construction activities to expand our site in East Windsor is a very exciting moment for us and for our customers. This is an important step to strengthen our continued commitment to the pharmaceutical industry and to the patients by offering innovative technologies and services. The site will be unique in offering at a single location drug substance, spray drying, hot melt extrusion and drug product manufacturing services using innovative continuous manufacturing technology. The state and especially the local government have been extremely supportive and we are happy to strengthen our presence in East Windsor by creating highly qualified jobs in the local community” said Dr. Marco Gil, General Manager, Hovione New Jersey. “This investment is part of the company’s strategy to increase its global development and commercial capacity which will meet the increasing demands of Hovione’s customers in the API and Spray drying services. It will also include the addition of a continuous drug product manufacturing capability to its offering through the partnership with Vertex Pharmaceuticals announced earlier this year” said Kristine Senft, Vice President Marketing and Sales.  The start-up of the operation is expected to take place in April 2017 for the drug substance and spray drying services while the continuous drug product manufacturing is planned for the end of 2017.   About Hovione Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area Hovione is the only independent company offering a complete range of services.

Press Release
Hovione announced today that it held on June 8th the official groundbreaking for the expansion of its New Jersey facility in East Windsor, USA

Hovione announces the groundbreaking expansion plans of its New Jersey Facility

Jun 16, 2016

The new office underlines the importance of Japan for Hovione’s business activities. Japan is a strategic market for Hovione where the company is growing both its off patent API and its contract manufacturing businesses. The new office will support customer relations and help in the development of new business within Japan, while reinforcing Hovione’s global position. “We are delighted to be opening our office in Osaka. Hovione’s advanced technologies and focus on quality gives us an excellent fit with the Japanese market so we wanted to have a local presence offering the best possible support to our customers” said Mrs. Kristine Senft, Hovione’s Vice-President of Marketing and Sales. “We are fortunate to have Mr. Yasushi Usuda leading our office as he is a Japanese national with 20 years international business experience. Mr. Usuda will ensure seamless communication with our customers and help us to develop our business even further.” said Dr. Roger Viney, Senior Director of Off-Patent APIs. The new office is located at 20F Hankyu Grand Building 8-47 Kakuda-cho, Kita-ku Osaka 530-00178, Japan. The office offers a good accessibility and is centrally located in Osaka next to the main train station.   About Hovione Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area Hovione is the only independent company offering a complete range of services.

Press Release
Loures, Portugal, June 6, 2016 – Hovione is pleased to announce the opening of its new sales and customer support office in Osaka, Japan.

Hovione opens a New Sales and Customer Support Office in Japan

Jun 06, 2016

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