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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

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. Read article

Article
C&EN, 20 May 2016

Japan’s generics market challenges foreign API makers

May 20, 2016

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