Yuhan Chemical Inc.

YUHAN CHEMICAL

Yuhan Chemical has been acknowledged as a cGMP compliant facility by the U.S.
and other advanced pharmaceutical countries’ customers through the successful outcome (No Form 483)
in 2002 U.S. FDA inspection after the company was being credited with Good Manufacturing Practices (GMP)
for APIs by the Korean Ministry of Food and Drug Safety (MFDS) in 1999.

Yuhan Chemical aims to establish a world-class GMP system. We have introduced Trackwise, which is a computerized quality management system, and have continued to strengthen our IT-based GMP system in order to meet the increasing quality requirements of regulatory agencies and customers.

Yuhan was designated as a BGMP qualified facility by MFDS in 1999. Since then,
Yuhan has faced many inspections by regulatory agencies such as US-FDA, Australian TGA, Japanese PMDA and Korean MFDS.

U.S FDA

2002, 2003, 2004,
2005, 2011, 2012,
2014, 2015, 2017

Australian TGA

2004, 2009,
2012

Japanese PMDA

2006, 2012
2013, 2017

Korean MFDS

2002, 2004, 2005,
2011, 2012, 2013 ,2014
2016, 2017

Features of GMP System

01: Build a World-Class GMP System
Yuhan Chemical is complying with the international standards (MFDS, USFDA, PMDA TGA, etc.). Its GMP quality system is based on the 6 Quality System. Yuhan Chemical aims for a world-class GMP system, and continues to improve the GMP system from a wealth of experiences in inspections and audits by numerous domestic/foreign regulatory agencies and pharmaceutical companies.

02: Supply Top-Quality APIs
Yuhan Chemical supplies APIs to multinational pharmaceutical companies around the world. We have grown as the best API manufacturer by possessing price competitiveness and manufacturing top-quality APIs with pro-environmental processes.

03: Strict Regulatory Compliance
Yuhan Chemical is producing APIs in compliance with the requirements of clients as well as regulatory authorities (MFDS, USFDA, PMDA, TGA, EDQM and EMA) in a strict manner.

04: Continuous Enhancement of Core Competencies
Yuhan Chemical continues to make an effort for the following activities to supply top-quality products as a API CMO company. - Carry out systematic and specialized education
- Construct production facilities with its up-to-date design and install testing instruments.
- Secure data integrity (computerized system) based on the 21 CFR Part 11
- CTD, CEP certificate, DMF and domestic/foreign authorization management
- Trust-based CMO partnership (quick customized response to customer requirement)

05: Thorough Quality Assurance
Yuhan Chemical’s employees make every effort to guarantee top quality throughout the manufacturing process of API with honesty, integrity and professionalism. We define a standard work procedure for every activity related to quality and our employees guarantee top quality by thoroughly following the GMP procedure.