- Supporting its continuing growth, Catalent Pharma Solutions is investing in a second clinical supply factory in Shanghai, China. The 30,000 square-feet facility doubles the contract manufacturer's total clinical storage capacity in the country, and is due to open in early 2019
- The facility will cost $2.5 million and include three controlled temperature rooms, along with returns and destruction services. The plant is located outside of the free trade zone in the Tangzhen district and is near the company's existing FTZ facility in Waigaoqiao.
- Catalent said both sites will offer in-country secondary packaging, final assembly, labeling and distribution of clinical supplies that meets good manufacturing practice standards. Those services should help address clinical supply needs inside China and the wider Asia-Pacific region.
The pharma industry has already picked much of the low-hanging fruit as far as medicines go. With pricey drug research and development, companies are looking to shore up bottom lines.
Outsourcing to contract manufacturers appears as one of the more popular ways to do that. There are a number of drivers behind the trend: the increasing complexity of some biologics that need specialist manufacturers; the greater squeeze payers are putting on drug pricing, leading developers to seek more cost-effective production; a growing requirement for fast and flexible production to get drugs to the right physicians and patients at the right time.
"This investment supports our commitment to providing customers with the facilities, and market access to optimize supply for their clinical trials," Roel de Nobel, vice president of global operations and clinical supply services Catalent, said in a Nov. 13 statement.
"Together, the facilities will provide both local and global customers with the most expedient pathways to run studies, saving them both time and cost," de Nobel said.
Historically, non-domestic companies have been wary of development and manufacturing in China because of concerns over patent protection and production quality. Local companies in China have significantly upped their game, though, attracting international players and spurring a rapid maturation of the Chinese drugs industry.
However, some Chinese companies do still have a ways to go. The Food and Drug Administration is watching closely, with over half of the notices sent this year by the Office of Manufacturing Quality in the FDA's Center for Drug Evaluation going to companies in China and India.
Catalent's expansion isn't just overseas. A little more than a year ago it picked up Cook Pharmica, a manufacturer based in Bloomington, Indiana, and this July it added Boston-based Juniper Pharmaceuticals to its business.