06.23.15
ScinoPharm Taiwan, Ltd. and Raffles PharmaTech are collaborating to manufacture Celecoxib, a non-steroidal and anti-inflammatory analgesic API. Raffles will be responsible for the R&D and ScinoPharm will be responsible for manufacturing. Following product launch, both companies will share profits. The drug master file (DMF) is expected to be submitted in 2016, with products available in the U.S. 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.”
Raffles PharmaTech, located in Huizhou, Guangdong, China, is focused on organic macromolecule catalysts and value-added pharmaceutical intermediates and APIs.
Celecoxib is effective in treating a number of common acute pain types, including acute tissue injury and postoperative pain. According to the forecast from Global Data, celecoxib sales in the U.S. are expected to reach $500 million in 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.”
Raffles PharmaTech, located in Huizhou, Guangdong, China, is focused on organic macromolecule catalysts and value-added pharmaceutical intermediates and APIs.
Celecoxib is effective in treating a number of common acute pain types, including acute tissue injury and postoperative pain. According to the forecast from Global Data, celecoxib sales in the U.S. are expected to reach $500 million in 2018.
