Hovione Macau

Manufacturing Plant

Established in 1986, the site was first approved by the FDA in 1987 and is regularly inspected.

Manufacturing Plant in Macau, China | Hovione

Hovione Macau was established in 1986 and has since been upgraded to boost production capacity as well as to install waste water treatment facilities. The plant was first approved by the FDA in 1987 and is regularly inspected. The plant holds a GMP Certificate issued by Infarmed, the Portuguese Health Authority.

With a total reactor capacity of approximately 100m3, Hovione Macau produces both generic and custom synthesis products. The plant benefits from its proximity to the People’s Republic of China for the supply of raw materials.

Area of Focused Expertise

The site has leading capabilities and physical assets in the following areas:

  • Cryogenic (Volume 6000L, Temperature Range -65 to 140ºC)
  • Hydrogenation (Volume 600L to 6000L, Pressure Rating 10 to 20bar)
  • Tetracycline and Macrolide chemistry

For details about production equipment – click here

Operations

  • The Macau plant operates 24 hours a day 7 days a week.
  • Quality Control labs supports production 24 hours a day 7 days a week.
  • Plant maintenance shutdown period takes place for 3 to 4 weeks in August.

Certifications

The site is certified in accordance with the ISO9001; ISO14001 and OHSAS18001.



 



 

 

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News

Investment More Than Doubles Capacity for Spray Drying, a Critical Solubility Enhancement Technology That Could Benefit the Development of 70% of Drugs 27 October 2025 -- New Jersey, US -- Hovione, a fully-integrated global CDMO, today announced the completion of an initial multi-million-dollar investment cycle to expand its manufacturing site in East Windsor, New Jersey. Upon completion, this world-class campus will cover more than 200,000 square feet, integrating the latest technologies within sustainably designed facilities. The initiative advances Hovione’s long-term strategy to grow its U.S. operations and enhance its integrated drug substance, drug product intermediate, and drug product capabilities. The initial expansion phase includes a 31,000-square-foot building that will house two size-3 spray dryers (PSD-3) designed for production of amorphous solid dispersions (ASDs) for the company´s customers that have an interest in having a supply node in North America. This investment more than doubles Hovione’s spray drying capacity in the United States, expanding capabilities for ASD development and commercial manufacturing. A global leader in ASD by spray drying for pharmaceutical applications, Hovione applies this critical technology to improve drug solubility and bioavailability across a wide range of compounds. Construction is already underway at the Hovione New Jersey site, with GMP operations planned to start in the second quarter of 2026. “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States,” said Jean-Luc Herbeaux, Ph.D., CEO of Hovione. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the U.S., we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Dr. Herbeaux continued, “This investment addresses growing customer demand for U.S.-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” As part of this expansion, Hovione has also acquired additional adjacent land to enable future growth and ensure the East Windsor site continues to meet evolving customer needs. The 125,000-square-foot greenfield will support large-scale production, including continuous and batch tableting capacity, and introduce the next generation of pharmaceutical technologies and digital innovation with enhanced quality control and R&D capabilities. David Basile, Vice President of Technical Operations – Americas at Hovione said, “This expansion in New Jersey marks a significant step in extending our capabilities in the U.S., which go far beyond machine time or equipment capacity. We are integrating our teams, specialized assets, proprietary technologies, and digital systems to deliver distinctive end-to-end ASD and continuous tableting platforms to our customers. Through our new strategic engagement model, customers can gain privileged access to innovation and assets that accelerate their programs and create long-term value.” Hovione’s expansion in East Windsor forms part of a broader international growth plan that also includes capacity investments in Ireland and Portugal. Together, these initiatives will create a network of autonomous sites spanning the development and commercialization of APIs, drug product intermediates, and drug products, all under harmonized quality systems. Drug developers seeking to expand U.S. manufacturing capacity, gain strategic access to critical assets, or achieve an expedited pathway to filing and commercialization, are invited to contact Hovione at www.hovione.com/contact-us to discuss potential collaborations. Read the full article at IPTOnline.com    

Press Clipping

Hovione Completes Initial $100M Investment Cycle to Expand U.S. Operations at New Jersey Manufacturing Site

Oct 27, 2025
Manufacturing Plant
Address

Hovione PharmaScience Ltd
Estrada Coronel Nicolau de Mesquita
Taipa
Macau
Tel: +853 2882 7544
Fax: +853 2882 7714
e-mail: infohm@hovione.com
DUNS Nr: 854974342 
Location: 22°09'28.62" N  113°33'40.58" E

FDA logo | Hovione
infarmed logo | Hovione
Hovione MACAU - ISO14001 and ISO45001
HKQAA Certified Company | Hovione

Other Locations

Hovione India

Office
Address

Hovione Holding Asia Limited
C/o WeWork, 2nd floor,
Oberoi Commerz - II,  1,
Off Western Express Highway,
Oberoi Garden City, Goregaon East,
Mumbai, Maharashtra 400063
India
Tel.: +919 561 830 188