Factory Introduction

SCP Group – Company History and Achievements and Certification

• 1967 – Officially approved by the government to establish Standard Chem. & Pharm. Co., Ltd.
• 1969 – Constructed a facility for the synthesis of active pharmaceutical ingredients (APIs).
• 1985 – Recognized by the government as a GMP-compliant pharmaceutical synthesis plant.
• 1995 – Approved by the Ministry of Finance for public listing.
• 1998 – Acquired ISO 9001 international quality certification.
• 2000 – Passed inspection by the U.S. Food and Drug Administration (FDA).
• 2007 – API plant certified by the Australian Therapeutic Goods Administration (TGA).

Awarded AAA certification for its e-learning unit under the National Digital Learning Technology Program.

• 2008 – Certified as a “Foreign Manufacturer” by the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
• 2009 – Met the PIC/S GMP pharmaceutical manufacturing standards of Taiwan’s Ministry of Health.
• 2010 – Achieved dual international certifications: ISO 14001 (Environmental Management) and OHSAS 18001 (Occupational Health & Safety).
• 2011 – Received “No Deficiencies” result during FDA post-approval inspection.
• 2012 – Passed inspection by the Korea Food and Drug Administration (KFDA).
• 2013 – Honored as one of the top three outstanding pharmaceutical companies in Taiwan.

Inaugurated a world-scale hydrogel patch plant, a joint venture between Jiangsu Dajia Co. and DIA Pharmaceuticals (Japan)..

Recent Achievements (2014–2022)

• 2014 – Received the Gold Award for Outstanding Biotech Enterprise in the biotech industry.
• 2015 – Obtained U.S. ANDA approval for a diabetes treatment drug.
• 2017 – Ranked among the top 6%–20% in corporate governance evaluation of publicly listed companies for two consecutive years.
• 2018 – Passed GMP inspections by Japan’s PMDA for both API and finished product facilities.
• 2019 –

– Ranked in the top 35% in the 5th corporate governance evaluation of listed companies.

– Became the exclusive distributor of Mylan’s oncology products launched in Taiwan.

• 2020

– Won the 19th Pharmaceutical Technology R&D Award – Gold Award in Manufacturing Technology for Co-Midis Tablets.

– Exported ALS (Amyotrophic Lateral Sclerosis) treatment drug to the U.S. market.

• 2021

– Again awarded the Gold Award for Outstanding Biotech Enterprise.

– Obtained U.S. ANDA approval for a multiple sclerosis treatment drug.

• 2022 – Won the Bronze Award in the National Pharmaceutical Technology R&D Awards – Manufacturing Technology category for Tamlosin Prolonged Release Tablets 0.4mg.