Manufacturing

Manufacturing

 

Prompt development and production of high-quality API products

ScinoPharm’s highly effective team of professionals, with R&D experts from Taiwan and China, together with its US Food and Drug Administration (FDA)-approved state-of-the-art Good Manufacturing Practice (cGMP) facilities, can assure the prompt development and manufacturing of high quality, price competitive, and non-patent infringing APIs to our customers.

ScinoPharm’s API plant has 16 cGMP-compliant production lines that can manufacture batches in kilograms to tons. There are six production lines that can manufacture high potency APIs such as hormones, cytotoxic agents, and APIs for injection formulations. ScinoPharm is experienced in preparing and submitting Drug Master Files (DMF) to US and European regulatory authorities. We regularly provide our customers with reference standards and complimentary transfer of validated analytical methods. All management, support, and control of production facilities are monitored and tracked by SAP’s enterprise resource planning (ERP) system.

 

Customer centricity and project management

ScinoPharm can provide the required speed and flexibility that large pharmaceutical companies look for when selecting a partner in the development of a new drug. ScinoPharm uses a matrix research organization with dedicated project teams that frequently and timely communication with our customers via e-mail, telephone, and videoconferencing. This is the reason why ScinoPharm can effectively become an extension of our customers’ in-house development team.