ScinoPharm Taiwan Ltd., a leading process R&D and API manufacturing service provider to the global pharma industry and Raffles PharmaTech have entered into a manufacturing collaboration for celecoxib, a non-steroidal and anti-inflammatory analgesic active pharmaceutical ingredient (API).
By combining the R&D expertise of Raffles and the commercial production capability of ScinoPharm (Changshu) Pharmaceuticals, Ltd., both sides aim to exploit greater business opportunities in the US market.
Concerning the collaborated production of celecoxib, Raffles will be responsible for the R&D, while ScinoPharm (Changshu) will be responsible for the manufacturing. After the product launch, both sides will share the profits. The drug master file (DMF) is expected to be submitted in 2016, and products will be available in the United States by 2018.
“ScinoPharm (Changshu) is among the first batch of API plants built in compliance with the regulations after the China Food and Drug Administration (CFDA) announced the new version of the GMP. In order to accelerate the momentum of the Changshu plant, ScinoPharm has simultaneously sought self-development and license-in models to quickly improve capacity utilization and accelerate the growth”, said ScinoPharm chief executive officer Dr. Yung Fa Chen. This collaboration case has adopted the license-in model to achieve competitive advantages in velocity, flexibility, and reliability, thereby providing high-quality API manufacturing services.
Celecoxib is effective in treating a number of common acute pain types, including acute tissue injury and postoperative pain. It is also effective in treating chronic pain, such as osteoarthritis and rheumatoid arthritis. This drug does not inhibit physiological enzymes that have a protective effect on the gastrointestinal tract, thus greatly reducing the risk of adverse reactions in the gastrointestinal tract. According to the forecast from Global Data, celecoxib sales in the US are expected to reach USD 500 million in 2018.
Raffles PharmaTech is located in Huizhou, Guangdong, China is focused on organic macromolecule catalysts, value-added pharmaceutical intermediates and APIs.