Manufacturing

Manufacturing

ScinoPharm's capable research and development teams, located in both Taiwan and China, in conjunction with its FDA approved state-of-the art cGMP facilities in Taiwan, can assure on-time development of non-infringing patent processes and timely delivery of high quality, price competitive API's to ScinoPharm's customers. 
 
Production of APIs is typically the most technically complex element of the pharmaceutical supply chain, especially when it involves high-potency and cytotoxic drug substances for injectable formulations. ScinoPharm’s US FDA-approved, world-class, Multi-purposed facilities are operated in strict conformity to international cGMP guidelines as well as safety and environment protection standards. Our quality manufacturing is further bolstered by the deployment of computer-controlled process and utilities systems.  With production scales ranging from kilograms to multi-tons, we can offer flexible manufacturing alternatives that maximize cost efficiencies.

The company is experienced in preparing and submitting Drug Master Files (DMF) with US and European regulatory agencies. ScinoPharm routinely provides its customers with reference standards and complimentary transfer of validated analytical methods. All administrative, support and control functions are monitored and tracked by Enterprise Resource Planning (ERP) automated system designed specifically for stand-alone API facilities.

ScinoPharm can provide the speed and flexibility that pharmaceutical companies require when selecting a partner to assist in developing clinical material. ScinoPharm utilizes a matrix research organization using a dedicated project team that emphasizes frequent and timely communications with its customers. Using e-mail and telephone/videoconferencing, ScinoPharm can effectively become an integral part of its customers' in-house development team.