Scinopharm Taiwan to build injectable drug facility
pharmafile | July 3, 2012 | News story | Manufacturing and Production |Â Â CMO, HPAPI, R&D, Scinopharm TaiwanÂ
Contract manufacturing organisation Scinopharm Taiwan has said it plans to invest around $37.6 million in a new high-potency active pharmaceutical ingredient (HPAPI) unit.
The investment at Scinopharm’s facility on the Tainan Science Park in Taiwan will boost the CMO’s ability to supply injectable cancer drugs, a fast-growing market that is currently facing supply constraints in the US, Europe and other markets around the world.
“The global demand for oncological injectable production capacity far exceeds the supply,” commented Dr Jo Shen, the firm’s president and chief executive.
“Many international generic customers of ours have been eagerly searching for partners who can provide a high quality and stable supply of oncological injectable drug products,” he added.
The CMO has been showing consistent growth in recent years thanks in part to its ability to supply critical cancer drugs such as docetaxel, irinotecan and paclitaxel, as well as non-oncological APIs such as antidepressant vilazodone and galantamine for dementia.
Cancer remains a major target for Scinopharm, however, and it now has 19 oncological drug master files (DMF) registered in the US, the largest number for any API supplier.
Scinopharm’s plans for the facility include R&D laboratories and areas for quality control, washing, sterilisation, manufacturing, filling, lyophilisation, packaging, and storage.
There will be one line for cytotoxic drug production featuring containment equipment that will be used for producing liquid and freeze-dried vials. Meanwhile, in a separate, isolated area, there will also be equipment for pre-filled syringes dedicated for non-cytotoxic products, it said. The entire injectable plant will meet international cGMP standards.
Design and construction of the plant is expected to begin in the second half of this year, with completion expected in 2014.
Meanwhile, Scinopharm continues to expand in other areas of manufacturing, with a steroid drug production line due to come online later this year and the first phase of its new Changshu API facility in Jiangsu, China, now completed.
Production pilot-runs for intermediates began at the end of last year at Changshu, and the second phase of construction is due to complete by the end of 2012.
Phil Taylor
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