06
May 2024
Latest News

ScinoPharm Taiwan Reports 36% YoY Revenue Growth in Q1; Both Injectable Plant and China Subsidiary Pass US FDA Inspection with Zero Deficiencies

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ScinoPharm Taiwan (stock code 1789) announced today that its consolidated revenue for the first quarter reached NT$883 million, representing an increase of 36.21% compared to the same period last year. ScinoPharm Taiwan achieved impressive results in the first quarter, maintaining the shipping demand seen in the previous year's fourth quarter. The sales momentum remained robust in the first quarter of 2024, resulting in increased shipments. Notably, drugs for Alzheimer's disease and cancer products served as the primary revenue drivers for generic active pharmaceutical ingredients in the first quarter, while contract manufacturing services were predominantly of drugs for epilepsy. Injectable contract manufacturing services also continued to contribute significantly to revenue. The first quarter consolidated net profit reached NT$140 million, marking a remarkable growth of 233% compared to the same period last year.

In response to the application for drug certification for formulated products, ScinoPharm Taiwan's injectable plant and its subsidiary ScinoPharm (Changshu) Pharmaceuticals underwent US FDA inspections in late March. Both facilities successfully passed the inspections with zero deficiencies (Zero Form 483), maintaining their outstanding inspection records. This achievement once again demonstrates that ScinoPharm Taiwan's product manufacturing and quality control procedures meet the highest standards of US FDA scrutiny. Its world-class personnel, equipment, systems, and operations solidify ScinoPharm Taiwan's competitiveness in production.

Previously, ScinoPharm Taiwan's injectable plant had several in-house injectable products across different production lines that had collectively passed US FDA inspections three times. In this latest inspection, the injection plant successfully underwent scrutiny for another proprietary injectable product and received approval. This success will further bolster ScinoPharm Taiwan's vertical integration development and contract manufacturing capabilities. Moreover, the recent FDA inspection of ScinoPharm's Changshu plant marked the first inspection since its successful US FDA inspection with zero deficiencies back in 2015. This inspection primarily targeted the auditing of GMP systems and three key products, all of which satisfactorily passed the verification process. With the optimization and improvements made to the Changshu plant last year, it is expected that the production capacity will continue to meet the substantial demand in the Chinese market.

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