The Nanchou Plant is located in the south of Taiwan with a space of 80,000 m2 and is a PIC/S GMP certified facility by the Taiwan FDA for the manufacture of the drug stance and the drug product.
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Quality Production Plant at the International Standard The Nanchou plant is set up in accordance with global standards, and has been issued the Certificate of Good Manufacturing Practice (PIC/S GMP) for the APIs, the Certificate of Good Manufacturing of Practice and Good Distribution Practice (PIC/S GMP and GDP) for the drug product, and the ISO 13485 Quality Management System for Medical Devices by the Ministry of Health and Welfare. The Nanchou plant is the production base of FESPIXON® cream and wound care medical device, and supplies drugs and medical devices in compliance with international quality system to meet the needs of the global market.
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Medicinal Herbs Cultivation The Plectranthus amboinicus plant cultivated in accordance with good agriculture and collection practice following the US FDA’s “Botanical Drug Development - Guidance for Industry”. This practice is implemented to ensure the quality consistency of the raw material. From the identification of the plant gene, preservation, seeding, harvesting, etc, all the procedure is under strict control. We have had more than 12 years experience in GACP.
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