BioDuro-Sundia Acquires US-Based Phase III / Commercial Pharmaceutical Manufacturing Plant

SAN DIEGO – (COMMERCIAL THREAD) – BioDuro-Sundia, a leading drug discovery and development services organization backed by Advent International, today announced that it has entered into a definitive agreement to acquire a2 commercial oral solid dose manufacturing facility located at 72 Fairbanks, Irvine, California, USA. Subject to the usual closure conditions, BioDuro-Sundia plans to start commercial service operations on the site on January 1, 2022.

“This fully audited and operational facility allows us to immediately support our customers who require larger scale commercial production,” said Kent Payne, who led the acquisition in his role as President, US Development and Manufacturing. EU at BioDuro-Sundia. “BioDuro-Sundia is a pioneer in improving bioavailability, with 25 years of experience in applying stabilized amorphous solid dispersion technology to poorly soluble drug candidates. Our customers have requested our support to provide commercial scale manufacturing to save time and maximize success, and it is a pleasure to take this next step with them.

The capacities of the new site include an annual capacity of over 1 billion units in tablets and encapsulation, as well as an aqueous and organic solvent process for the fluidized bed and coating capacities.

BioDuro-Sundia immediately makes new investments in equipment to support the business operation, including commercial spray drying capacity of up to 100 kg / h and hot extrusion capacity of up to 30 kg / h. These capabilities provide a commercial extension to the company’s existing oral solids development and manufacturing capabilities.

“We are dedicated to our customers at all phases of drug discovery, development and manufacturing,” said Payne. “This means an ongoing investment in our capabilities, as we have done with our new 150,000ft.2 R&D site in Wuxi City last year, and now our US-based commercial pharmaceutical manufacturing site. In partnership with our investors, Advent International, we are committed to accelerating growth to support our clients from discovery to commercialization. The results are good for all stakeholders, and particularly critical for our pharmaceutical partners who benefit from integrated services with a saving of time and a quality drug product.

About BioDuro-Sundia

BioDuro-Sundia, a portfolio company of Advent International, is a leading contract research, development and manufacturing (CRDMO) organization that provides biopharmaceutical partners with fully integrated services to support discovery, development and manufacture of medicaments for the drug substance and drug product. The company is the third largest in the industry, with major operations in China and the United States, with more than 2,000 employees and 10 global locations.

Core expertise includes discovery, development and scaling of small and large molecules, support for IND submission, and unique technology platforms such as improving the bioavailability of insoluble compounds. . The company has research sites, as well as GMP manufacturing facilities in China and the United States. The one-stop-shop operation helps biopharmaceutical partners across the globe dramatically accelerate risk reduction discovery and development to create higher value-added outcomes.

BioDuro-Sundia’s investment is led by Advent International, with support from Bridgewest Business Group.

For more information visit:

www.bioduro-sundia.com

About Avent International

Founded in 1984, Advent International is one of the world’s largest and most experienced private equity investors. The company has invested in more than 350 private equity deals in 41 countries and, as of June 30, 2020, had $ 58.4 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of more than 200 investment professionals in North America, Europe, Latin America and Asia. The company focuses on investments in five key sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years of international investing, Advent remains committed to partnering with management teams to generate sustained revenue and earnings growth for its portfolio companies.

For more information visit:

www.adventinternational.com

About Bridgewest Business Group

Founded in 1999, The Bridgewest Business Group is a private equity investment firm that seeks to create long-term value by applying superior industry knowledge, operational expertise and significant financial resources to business opportunities. attractive investment. The Group structures its global investments in four functional areas, including private equity, real estate, capital markets and financial services. The Group’s private equity investments are mainly in biotechnology, wireless communications, IoT infrastructure and semiconductors. Bridgewest is based in San Diego, California, and has investments in the United States, Europe, Asia, and Australasia.

For more information visit:

www.bridgewestgroup.com

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