Shanghai, July 1st, 2022 – BioDuro-Sundia, a leading drug discovery, development and commercial services organization backed by Advent International, announced today that the company’s GMP manufacturing facility in Wuxi successfully passed a comprehensive inspection by the Medical Products Administration of Province Jiangsu (JSMPA) and was granted a drug manufacturing license. This marks a further upgrade of the company’s preparation capacity and a new level of development scale.
The BioDuro-Sundia’s GMP drug product manufacturing facility in Wuxi officially opened in September 2020. The total area of the GMP facility is 2,000 square meters. It can provide drug product GMP manufacturing services for oral solid dosage forms. The facility is managed under strict accordance with GMP requirements, and has established a complete system of quality management, production management, and material management systems. The manufacturing capacities include weighing, milling, micronization, dry granulation, wet granulation, mixing, hot melt extrusion, spray drying, tableting, coating, capsule filling, spray drying, primary and secondary packaging. It offers an industry-leading Pharma 24 twin-screw hot melt extruder, GEA PSD-1 spray dryer, Maxim technology MXM 100 jet mill, Xinma DG150 dry granulator, S250 rotary tablet press, Z40 capsule filling machine, P Lab coating machine, and DPP-140F blister packaging machine, which can meet the requirements of micronization, hot melt extrusion, spray drying, dry granulation, wet granulation, tableting, coating, capsule filling and other process.
BioDuro-Sundia’s cGMP facility operations focus on product quality, productivity and reliability to ensure timely delivery of clinical trial samples. Its highly skilled manufacturing team, experienced formulation specialists, mobile processing facilities and flexible workshop facilities, as well as compliance oversight by quality management departments, demonstrate the company’s commitment to superior performance and the highest quality standards in manufacturing. The company’s formulation production capabilities range from specialized spray drying and hot melt extrusion processes to full stage clinical sample GMP preparation services for tablets, capsules, and pellet preparations.
BioDuro-Sundia, an Advent International portfolio company, is a leading contract research, development and manufacturing organization (CRDMO) that provides biopharmaceutical partners with fully integrated services to support drug discovery, development and manufacturing for both drug substance and drug product – from discovery to commercialization. The company is the industry’s third largest, with major operations in China and the US—featuring more than 2,500 employees and 10 global sites.
Core expertise includes small and large molecule discovery, development and scale up, support for IND submission, and unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has research sites, as well as GMP manufacturing facilities in both China and the US. The one-stop-shop operation helps biopharma partners across the globe to significantly accelerate discovery and de-risk development to create higher value outcomes.
BioDuro-Sundia investment is led by Advent International, with backing from Bridgewest Business Group.
For more information, visit: www.bioduro-sundia.com