ScinoPharm’s Injectable and API Plants Pass FDA’s Pre-Approval On-Site Inspections

ScinoPharm’s Injectable and API Plants Pass FDA’s Pre-Approval On-Site Inspections

2022/12/30

ScinoPharm Taiwan's lyophilized injectables production line passed TFDA's GMP and GDP compliance assessment in 2021. Since then, ScinoPharm's pre-filled syringe and liquid injectable products, and lyophilized injectables passed the FDA's pre-approval on-site inspections in March and October 2022. Last October's plant inspection included a review of the items of the injectable plant and a GMP audit of the entire API and injectable plants. This inspection resulted in a shining achievement of zero 483 observations.

The results of these official inspections demonstrate ScinoPharm's relentless commitment to drug safety and its high standards in continuously improving production processes and quality control. ScinoPharm's quality technology and professionalism have instilled confidence in customers, which will fuel the future development of injectables and more robust vertical integration.