Press Room

The Macau plant run by Portuguese pharmaceutical chemical firm Hovione could well be the only drug facility in the world to be located in a gaming mecca. Macau is Las Vegas transplanted to southern China. Sands, Venetian, and other companies that operate casinos, hotels, and convention centers in Las Vegas have been setting up grandiose facilities in Macau since the end of the gaming monopoly there. Since then, Macau has experienced an unprecedented construction boom.   Read full article at C&EN website

Article
C&EN, 19 December 2005

Hovione In Macau: Pharmaceutical ingredient plant is an important part of firm's global network

Dec 19, 2005

To address a significant market interest in Advanced APIs (aAPI®), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying, an advanced particle design technology. Building on its accumulated expertise in all major areas of API development and cGMP manufacture, a full range of cGMP Spray Drying facilities operating at lab, pilot and industrial scale have now been installed at Hovione's API manufacturing plant in Europe and are currently being installed at Hovione’s Technology Transfer Centre in New Jersey, USA. Building on the state-of-the-art spray drying industrial facility installed in 2004, Hovione now operates three additional units at lab scale and two others at pilot scale. All units comply to the most stringent cGMP requirements, allowing production from just a few grams for feasibility studies to full scale commercial production. Offering process scale-up throughout all phases of product development, Hovione's multi-scale spray drying facilities further widen our ability to provide customized solutions. Designed to support both Custom Synthesis and Generic Product customers, Hovione’s spray drying technology is complemented by complete R&D and analytical studies on particle properties as per specific product requirements, thus offering all expertise and capabilities for successful product development. All Hovione spray dryers operate with nitrogen as the drying gas and are designed to support both aqueous and organic feeds. The manipulation of the operational parameters during spray drying offers the possibility to control the design of the particle and it’s attributes to meet the requirements of final product. Optimal sizing and shaping of particles, together with a variety of encapsulation options, can improve product stability and bioavailability. Spray drying also overcomes micronization issues associated with conventional grinding and jet milling processes. The industrial unit has the versatility of operating as a conventional spray dryer or as a fluidized spray dryer. In conventional spray drying operation the process involves continuous atomization of solutions, suspensions and emulsions to generate from ultra-fine particles (below 5-10 micron) up to large particles (100 micron) either in amorphous or crystalline form. In fluidized spray drying, the unit produces dustless free flowing agglomerated powders (up to 400 microns) that can be directly compressible, have increased bulk/tap density, and demonstrate improved wettability/dissolution behavior. Operation in either mode can have applications for processing thermally labile APIs, co-processing APIs with inactive ingredients, as-well-as aid in the reduction of residual solvents and OVIs. Moreover, complementing Hovione’s growing suite of cutting-edge capabilities, the Company is investing in other state-of-the-art technologies, which will further enhance our particle engineering capabilities.   About Hovione Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and aAPIs® for the Pharmaceutical Industry. With a 45-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization.

Press Release
To address a significant market interest in Advanced APIs (aAPI®), Hovione has increased its range of services and multi-scale facilities in cGMP Spray Drying

Hovione expands its range of services in Particle Design technology

Aug 17, 2005

Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2005 amounted to US$81.4 million, representing a growth of 8% over the previous year. Guy Villax, CEO of Hovione noted that "Hovione's sales have shown continuous growth over the past 4 years, an increase of 50% over that period. Although our results are unsatisfactory with an EBITDA of US$16m (against US$18m in 2003), this is still a good performance when the harsh environment we face is considered. We continue to be affected by the strength of the dollar – over the same period our major invoicing currency has weakened 41%. Our sector has seen much red ink – a recent presentation by Peter Pollak shows that the seven largest players in the pharma fine chemicals sector have had, between 2002 and 2004, an average 14% negative sales growth. In Generics, both in the USA and in Europe, companies are facing aggressive price-cutting from new entrants, mainly from India. Our success is primarily due to the increasing differentiation of the products Hovione offers – a value proposition centered around high service, R&D and compliance." The results in Portugal were affected by the depreciation of the US dollar that has weakened the company’s competitiveness by a further 5% this year. Exports from Portugal decreased by 4.2%. On the other hand, supported by our New Jersey Technology Transfer Center, sales of R&D process development were very positive. The income from such services almost doubled over 2003. Capital expenditure was reduced to US$4.3m, a substantial reduction when compared to US$13.3m invested last year, reflecting the Company’s objective to improve its returns on assets and taking a prudent position as a result of the negative exchange rate climate. This year was also positive in terms of results of the technology investments Hovione has done in the past 3 years. Hovione has chosen to become a leader in the field of particle design. Spray-drying and spray-congealing at very low temperatures have taken us to near nano-scale particles. Hovione now offers this technical expertise at its Portugal site at every scale - lab, pilot and industrial – all within a GMP compliant environment and will soon be offering similar services from Technology Centre in the USA. In terms of geography, Hovione sales mirror the world pharma market, with the USA accounting for almost half its sales, Europe and Japan with even shares, and about 10% going to other markets such as Australia and Singapore. Hovione’s Technology Transfer Centre (TTC) in the USA has had a leading role in the Group’s activities, contributing not only to consolidate Hovione’s presence in the US market, but also to contracting an ever increasing number of new projects from US and European Biotechs. The TTC currently employs 37 people.   About Hovione Hovione is a fine chemicals company dedicated to the process development and compliant manufacture of APIs for the pharmaceutical industry, both on an exclusive basis and for the generics market. With FDA inspected plants in Europe and the Far East, and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service and quality. With more than 45 years experience in API development from gram scale to commercialization, Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex APIs under FDA and ICH cGMP quality standards. More recently, Hovione has added process capabilities in the areas of particle design and inhalation drug delivery, manufacturing galenically enhanced APIs.

Press Release
Hovione announces that the consolidated sales volume for the fiscal year ended 31st March 2005 amounted to US$81.4 million, representing a growth of 8% over the previous year.

Hovione Group sales grow 8% for fiscal year 2004/05

Aug 01, 2005

Allos Therapeutics, Inc. (Nasdaq: ALTH) and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium. Under the agreement, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support Allos' anticipated requirements for both the pre-and post-commercialization phases of production. EFAPROXYN is currently the subject of a confirmatory Phase 3 trial, called ENRICH, designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without EFAPROXYN in women with brain metastases originating from breast cancer. This randomized, open-label study will seek to enroll 360 patients at up to 125 leading cancer centers across North America, Europe and South America. The trial began in February 2004 and is expected to complete enrollment during the second half of 2006. The manufacturing agreement is the most recent step in a relationship between the two companies that began in 1997. Under a prior agreement between the parties, Hovione manufactured a majority of the bulk drug substance used by Allos in its clinical trials of EFAPROXYN. Hovione has already manufactured four batches of efaproxiral sodium at commercial scale using a process that they successfully validated in 2001. Hovione is in good standing with the FDA, having passed recent inspections. "This manufacturing agreement is an important step in our preparation for the potential commercialization of EFAPROXYN," said Michael E. Hart, President and Chief Executive Officer of Allos. "We have benefited from Hovione's commitment to working with companies like Allos and feel that Hovione's expertise in production of APIs for injectable products makes them an ideal partner for us." About EFAPROXYN EFAPROXYN is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy. About Allos Therapeutics, Inc. Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos' lead product candidate, EFAPROXYN, is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. Allos' other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation as both a single agent and in combination therapy regimens in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, visit the company's website at www.allos.com About Hovione Hovione, based in Portugal, is an international group dedicated to the process development and synthesis of active pharmaceutical ingredients serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service, technical expertise and cGMP quality standards. Hovione focuses on finding scientific and industrial solutions for APIs of increased complexity and for Enhanced APIs(TM) having developed, among other, special process capabilities in the areas of injectable grade APIs, particle design and inhalation drug delivery. For more information, visit the company's website at www.hovione.com Safe Harbor Statement This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning Allos' projected timelines for completing enrollment in the ENRICH study, the potential safety and efficacy of EFAPROXYN, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that Allos may experience difficulties or delays in its clinical trials, whether caused by adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that clinical trials may not demonstrate the safety and efficacy of Allos' product candidates in their target indications. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of Allos' Annual Report on Form 10-K for the year ended December 31, 2004 and in Allos' other periodic reports and filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Allos cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law. Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics, Inc. SOURCE: Allos Therapeutics, Inc.; Hovione Jennifer Neiman, Manager, Corporate Communications of Allos Therapeutics, +1-720-540-5227; or Isabel Pina, Corporate Communication Manager of Hovione, +351-21-982-9362   Allos Therapeutics and Hovione Enter Into Manufacturing Agreement for EFAPROXYN(TM) Bulk Drug Substance 16/06/2005 Allos Therapeutics, Inc. (Nasdaq: ALTH) and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium. Under the agreement, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support Allos' anticipated requirements for both the pre-and post-commercialization phases of production. EFAPROXYN is currently the subject of a confirmatory Phase 3 trial, called ENRICH, designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without EFAPROXYN in women with brain metastases originating from breast cancer. This randomized, open-label study will seek to enroll 360 patients at up to 125 leading cancer centers across North America, Europe and South America. The trial began in February 2004 and is expected to complete enrollment during the second half of 2006. The manufacturing agreement is the most recent step in a relationship between the two companies that began in 1997. Under a prior agreement between the parties, Hovione manufactured a majority of the bulk drug substance used by Allos in its clinical trials of EFAPROXYN. Hovione has already manufactured four batches of efaproxiral sodium at commercial scale using a process that they successfully validated in 2001. Hovione is in good standing with the FDA, having passed recent inspections. "This manufacturing agreement is an important step in our preparation for the potential commercialization of EFAPROXYN," said Michael E. Hart, President and Chief Executive Officer of Allos. "We have benefited from Hovione's commitment to working with companies like Allos and feel that Hovione's expertise in production of APIs for injectable products makes them an ideal partner for us."   About EFAPROXYN EFAPROXYN is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that EFAPROXYN has the potential to enhance the efficacy of standard radiation therapy. About Allos Therapeutics, Inc. Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos' lead product candidate, EFAPROXYN, is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy. EFAPROXYN is currently being evaluated as an adjunct to whole brain radiation therapy in a pivotal Phase 3 trial in women with brain metastases originating from breast cancer. Allos' other product candidates are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under investigation as both a single agent and in combination therapy regimens in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced solid tumors. For more information, visit the company's web site at www.allos.com. About Hovione Hovione, based in Portugal, is an international group dedicated to the process development and synthesis of active pharmaceutical ingredients serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service, technical expertise and cGMP quality standards. Hovione focuses on finding scientific and industrial solutions for APIs of increased complexity and for Enhanced APIs(TM) having developed, among other, special process capabilities in the areas of injectable grade APIs, particle design and inhalation drug delivery. For more information, visit the company's web site at www.hovione.com.   Safe Harbor Statement This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements concerning Allos' projected timelines for completing enrollment in the ENRICH study, the potential safety and efficacy of EFAPROXYN, and other statements which are other than statements of historical facts. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negative of these terms, but their absence does not mean that a particular statement is not forward-looking. Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that Allos may experience difficulties or delays in its clinical trials, whether caused by adverse events, investigative site initiation rates, patient enrollment rates, regulatory issues or other factors; and that clinical trials may not demonstrate the safety and efficacy of Allos' product candidates in their target indications. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of Allos' Annual Report on Form 10-K for the year ended December 31, 2004 and in Allos' other periodic reports and filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. Allos cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Allos on the date hereof, and Allos undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law. Note: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics, Inc. SOURCE: Allos Therapeutics, Inc.; Hovione Jennifer Neiman, Manager, Corporate Communications of Allos Therapeutics, +1-720-540-5227, jneiman@allos.com ; or Isabel Pina, Corporate Communication Manager of Hovione, +351-21-982-9362, e-mail: )

Press Release
Allos Therapeutics, Inc. and Hovione announced today that they have entered into a long-term manufacturing agreement for the supply of EFAPROXYN bulk drug substance, efaproxiral sodium.

Allos Therapeutics and Hovione Enter Into Manufacturing Agreement for EFAPROXYN(TM) Bulk Drug Substance

Jun 16, 2005

Hovione's commitment to supporting the high risk business of drug development is paying off. In the Goldman Sach's list of 19 new compounds to be approved by FDA during 2005, Hovione is involved in no less than 3 new chemical entities and may well become a second source supplier to another two - all for American clients. The Portugal-based international company has a product range that includes 17 commercial phase active pharmaceutical ingredients, and supplies clinical trial materials for a further 30 compounds still in the various phases of drug development. "We have committed considerable people and resources to supporting the innovation efforts of both large Pharma and Biotechs for over a decade now. Our R&D is focused on process chemistry; we do it well, and can provide a fast and cost effective service to the pharmaceutical industry as a whole. Drug development is increasingly complex and certain technical areas are best outsourced to specialists, who have solved similar problems in the past. One of our customer's drug got approved by FDA last month, and we expect another 2 NCE approvals in the next year or so - it's a record for us. We are very excited but these days nothing is risk-free - drug development is not for the faint-hearted." says Guy Villax, Chief Executive. The last decade has seen innovation shifting away from the exclusive preserve of the traditional pharma multinationals to the stock-market and venture capital driven Biotech sector. Hovione anticipated this and invested in a green-field tech-transfer centre in New Jersey, USA, in order to be closer to the science and the innovators. "We have been operating a kilo-lab and a pilot plant in New Jersey for two years now. Our Princeton location gives us proximity to customers and to the FDA and frees us from the frustrating bureaucracies that have handicapped us in Europe. Our 5 decades of experience and unblemished track record at the health authorities present great value for the smaller innovator companies. Business is good but the weak dollar hurts our financial results; in any case with these approvals we cannot complain. We had an exciting 2004 despite all the negative news, we have added 5 new clients and 9 new projects to our growing list of both customers and projects.", says Dave Hoffman, President US Operations.   Expected product launches for 2005 with peak sales >US$200mn Drug Originator Peak sales estimate ($ mn) Status Boniva (ibandronate) Roche/GSK   950 Filed Indiplon Pfizer 800 Filed SU11248 Pfizer 800 III nelarabine GSK 700 III Entereg (alvimopan) GSK 700 Filed abatacept Bristol Myers 600 III capravirine Pfizer/Shionogi 600 III Dynestat (parecoxib) Pfizer 660 III exenatide Eli Lilly 500 Filed Macugen (pegaptanib) Pfizer 500 Filed Noxafil (posaconazole) Schering Plough 500 III Alvesco (ciclesonide) sanofi-aventis 480 Filed US, Approved UK entecavir Bristol Myers 400 Filed Yentreve (duloxetine) Eli Lilly 400 Approvable Asmanex (mometasone) Schering Plough 300 III DV-7314 (clopidogrel) Daiichi 300 Filed Tygacil (tigecycline) Wyeth 250 III Vaprisol Yamanouchi 200 Filed Exubera sanofi-aventis/Pfizer 200 III (US) /Filed(EU)     Source: Company data, Goldman Sachs Research estimates. Hovione is a fine chemicals company dedicated to the process development and compliant manufacture of APIs for the pharmaceutical industry, both on an exclusive basis and for the generics market. With FDA inspected plants in Europe and the Far East, and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service and quality. With more than 45 years experience in API development from gram scale to commercialization, Hovione´s capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex APIs under FDA and ICH cGMP quality standards. More recently, Hovione has added process capabilities in the areas of particle design and inhalation drug delivery, manufacturing enhanced APIs.

Press Release
Hovione's commitment to supporting the high risk business of drug development is paying off.

Hovione stands behind 3 NCE launches

Apr 07, 2005

Interview with Hovione's CEO, Guy Villax. “Many of the new compounds in development present significant challenges. For example, they may be very fragile, and in simple terms, galenic techniques enable the chemist to isolate the API already in a preformulated more stable form. We call these Enhanced APIs.” There is much talk about the convergence of disciplines in the life-sciences area. Hovione has been involved in manufacturing APIs under current cGMP for nearly 50 years. Many development candidates present an increasing set of challenges: complexity of the molecule, poor bioavailability yet highly potent, very high purity, poor stability, etc.....often simultaneously. Meeting these demands has opened opportunities for the “top-of-the-line” Contract Manufacturing Organizations to develop strengths in new disciplines and to combine capabilities never before found on the same campus, let alone within a validated commercial scale GMP environment. Hovione has traditionally been a CMO of small molecules and is now adding new skills and capabilities that address the special needs of large molecules, peptides, and antibodies. Hence, Hovione now offers a range of galenic enhancements that contribute decisively to making certain APIs into viable industrial propositions, in purpose-designed containment areas built to uncommon standards, to serve projects managed with multidisciplinary staff. Drug Delivery Technology recently interviewed Mr. Guy Villax, Hovione’s CEO, to discuss his company’s philosophy and business strategy, a vision based on an intimate understanding of client needs and technology trends. APIs of the 21st century present increased difficulties not only in their traditional fields (chemistry, engineering, analytical chemistry), but in new areas of technology as well as management.     Small-molecule chemistry      

Article
Drug Delivery Technology, March 2005

Hovione: More Than Just Very Good

Mar 01, 2005

Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA; this was triggered by a filing by a US customer. The inspection, carried out by Ms. Karen Moksnes, Compliance Officer at the U.S. FDA Center for Drug Evaluation and Research (CDER) and by Ms. Susan Ting, Chemist at the U.S. FDA Office of Regulatory Affairs (ORA), lasted 3 days, and resulted in a Form 483 with two minor points. Mr. Luis Gomes, General Manager of the plant, said "the inspection was concluded one day early, and by the closing meeting the two points had been satisfactorily addressed". Hovione plants have been the object of 13 FDA inspections, with 5 at the Macau site since it started to operate in 1986. This inspection reflected the "Risk-Based Management Plan" described in its Pharmaceutical Quality for the 21st Century: The emphasis is on the design and operation of the quality system and on the competence and understanding of the operators and analysts. The thoroughness of the inspection and its ability to make an assessment of the maturity of "GMP mindedness" is far greater. The obvious objective is to be able to determine the plants', and the plant management's, "credibility and reliability" rating that is used in FDA's Risk-Based calculations. The Macau plant has today a total workforce of 133 professionals and produces both Hovione catalogue generic products and commercial APIs manufactured under exclusivity and has been increasingly used by Hovione customers to produce on an exclusive basis clinical trial quantities of compounds for Phase I and II testing. The facility is responsible for one third of Hovione’s total production, and exports to the most demanding markets such as the USA, EU, and Australia.   About Hovione Hovione is a world-class company dedicated to the process development and compliant manufacture of APIs and eAPIs for the Pharmaceutical Industry. With a 40-year track record of quality standard and advanced particle design technologies, such as micronization, jet milling and spray drying, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, no manufacturing partner is better positioned to support your API development from gram scale to commercialization. Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards. Hovione has process capabilities in the areas of particle design and inhalation drug delivery.

Press Release
Hovione's active pharmaceutical ingredients plant in Macau underwent a pre-approval inspection by FDA

FDA inspects Hovione's API manufacturing plant in Macau

Nov 11, 2004

Contact Us

If you would like to learn more about Hovione, kindly fill in the form below and we will be revert to you soon.