ScinoPharm Taiwan (SPT) (stock code 1789) has not only solidified its position in the US and EU pharmaceutical markets, but is continuing to extend its reach into promising emerging markets, demonstrating its commitment to expand its global footprint. With 10 active pharmaceutical ingredients (API) already registered with the Brazilian Health Regulatory Agency (ANVISA) through ScinoPharm Taiwan’s drug product customers, SPT also successfully passed its first on-site GMP inspection (November 11 to November 15, 2024) with zero defects.
This recent inspection focused on SPT’s API production facilities, encompassing a comprehensive range of cytotoxic, non-cytotoxic, and steroid production lines. This five-day comprehensive audit was based on RDC 654/2022, Brazil’s GMP regulation for APIs, which covered diverse areas, including hardware infrastructure (such as water and air conditioning systems), production processes, quality management systems, quality control testing, warehouse management for raw materials and finished products, risk assessment, and regulatory compliance. This was ANVISA’s first on-site inspection of a Taiwanese API manufacturer since the pandemic, and with the remarkable result of zero defects, it marks yet another major milestone in the company’s expansion into the Brazilian market as well as illustrating SPT’s world-class pharmaceutical capabilities and exceptional GMP track record, which includes 5 consecutive zero defect inspections by the U.S. FDA.
The successful inspection paves the way for ScinoPharm’s customers to obtain drug approvals in Brazil quickly, further promoting the sales of related products in the Brazilian market. As the world’s 5th largest pharmaceutical market, Brazil offers immense growth potential, and ScinoPharm’s premium API products will offer a more competitive choice for the Brazilian pharmaceutical market.
ScinoPharm Taiwan is a specialized company dedicated to the development and manufacturing of high-quality APIs and injectable products. By upholding rigorous quality standards, it is committed to attaining global leadership as a supplier of APIs, injectable products, and as a manufacturing partner. The company has obtained the recognition of international regulatory agencies and continues to expand its operations into emerging markets to satisfy the increasing demands of the global pharmaceutical industry.