Company Overview
Hanmi Pharmaceutical
Hanmi Pharmaceutical, Korea's Leading R&D-focused Pharmaceutical and Bio Company
Founded in 1973 by pharmacist Lim Sung Ki, Hanmi Pharmaceutical embraces 'Respect for Human Beings' and 'Value Creation' as its management philosophies. It is Korea's leading R&D-focused pharmaceutical and bio company, constantly pursuing innovation through continuous R&D and a challenging spirit. Hanmi Pharmaceutical strives to contribute to protecting human health and life, and to become a leading company in the Korean pharmaceutical industry that can provide solutions to the various challenges facing the pharmaceutical industry.
Company Name | Hanmi Pharmaceutical Co., Ltd. |
|---|---|
CEO | Hwang Sangyoun |
Founding Date | June 15, 1973 (Spin-off Date: July 1, 2010) |
Business Address | Head Office: 14 Wiryeseong-daero, Songpa-gu, Seoul |
Main Business | Purpose of Business: Pharmaceutical manufacturing and sales, global innovative new drug development |
Main Business Regions | South Korea (Head office location), USA, China, Japan |
Largest Shareholder and Subsidiary Status (including affiliates)
Open Square for Tomorrow, Hanmi C&C Square
In November 2025, Hanmi C&C Square, a new work and welfare complex facility of Hanmi Group, built on a scale of 7,305.9㎡ across 5 basement floors and 13 above-ground floors, was completed. The 'C&C' in Hanmi C&C Square signifies Hanmi Group's top priorities: Creation and Challenge, Connect and Communicate.
Hanmi C&C Square is intended to be used as a complex space that goes beyond a simple workspace, encompassing elements of employees' families, health, and culture. Currently, in addition to office spaces, it operates an on-site daycare center, an employee fitness center, and an exclusive employee café (Equal Garden).
Hanmi Group will foster a work culture where employees can simultaneously enhance work efficiency and quality of life in the best possible environment, and based on this, lead sustainable innovation.
Production Facilities | Paltan Smart Plant
Located in Paltan, Gyeonggi-do, South Korea, the Paltan Smart Plant is Hanmi Pharmaceutical's central production base for synthetic drugs, a global manufacturing facility with an annual production capacity of over 6 billion tablets. Based on cutting-edge systems and advanced production processes, it has obtained Good Manufacturing Practice (GMP certification) from major advanced pharmaceutical and bio countries and currently exports finished synthetic drugs to various countries worldwide. Notably, the latest ICT (Information and Communication Technology) is applied to all processes, resulting in 90% of the manufacturing and production processes being implemented through automated systems.
GMP Certification Status
Category | Approval Authority | Country |
|---|---|---|
GMP Certificate Acquired | MRA | Syria |
Sterile Plant Registration | MHLW | Japan |
GMP Certificate Acquired | ANVISA | Brazil |
GMP Certificate Acquired | DIGEMID | Peru |
Factory Registration | Gulf Cooperation Council (GCC) | Arab Countries |
GMP Certificate Acquired | SAUMP | Ukraine |
GMP Certificate Acquired | BGV | Germany |
GMP Certificate Acquired | Pharmacy and Poisons Board | Kenya |
Non-Sterile Factory Registration | MHLW | Japan |
GMP Certificate Acquired | USFDA | USA |
Non-Sterile Factory Registration | TFDA | Taiwan |
GMP Certificate Acquired | Philippines FDA | Philippines |
GMP Certificate Acquired | MITRF | Russia |
GMP Certificate Acquired | NMPA | China |
GMP Certificate Acquired | ANVISA | Brazil |
GMP Certificate Acquired | PMDA | Japan |
Status of International Management System Certifications
Category | Content | Period |
|---|---|---|
ISO 14001 | Environmental Management System | 2023.09.29 ~ 2026.09.28 |
ISO 45001 | Occupational Health and Safety Management System | 2024.09.23 ~ 2027.09.22 |
ISO 22301 | Business Continuity Management System | 2025.12.13 ~ 2028.12.12 |
ISO 27001 | Information Security Management System | 2024.12.19 ~ 2027.12.18 |
ISO 37001 | Anti-Bribery Management System | 2024.11.29 ~ 2026.11.27 |
ISO 37301 | Compliance Management System | 2024.11.29 ~ 2027.11.28 |
Production Facility | Pyeongtaek Bioplant
The Pyeongtaek Bioplant, located in Pyeongtaek, Gyeonggi-do, Republic of Korea, is a production facility that manufactures Hanmi Pharmaceutical's biopharmaceuticals. It supplies commercialized biopharmaceutical products, approved by the U.S. FDA and the Korea Ministry of Food and Drug Safety(MFDS), to the U.S. and Korean markets. Optimized for microbial-based biopharmaceutical production, Hanmi Pharmaceutical's Pyeongtaek Bioplant boasts advanced large-scale manufacturing facilities with a maximum capacity of 25,000 liters, and also houses within the same site a pre-filled syringe finished drug product manufacturing facility capable of producing over 24 million units annually.
GMP Certification Status
Category | Approval Authority | Country |
|---|---|---|
Finished Drug Product (Aseptic) and API GMP Certification | MFDS | South Korea |
USFDA GMP Establishment Inspection Pass | CDER, FDA | USA |
USFDA GMP Establishment Inspection Pass | CDRH, FDA | USA |
Certificate of GMP compliance of a biopharmaceuticals | MFDS | South Korea |
International Management System Certification Status
Category | Content | Period |
|---|---|---|
ISO 14001 | Environmental Management System | 2023.12.07 ~ 2026.12.06 |
ISO 45001 | Occupational Health and Safety Management System | 2023.12.07 ~ 2026.12.06 |
ISO 22301 | Business Continuity Management System | 2025.12.13 ~ 2028.12.12 |
ISO 37001 | Anti-Bribery Management System | 2024.11.29 ~ 2026.11.27 |
ISO 37301 | Compliance Management System | 2024.11.29 ~ 2027.11.28 |
ISO 13485 | Medical Device Quality Management System | 2026.01.21 ~ 2029.01.21 |
PSM P Grade | Process Safety Management System | 2022.07.01 ~ 2026.06.30 |
Subsidiary | Beijing Hanmi Pharmaceutical
Company Name | Beijing Hanmi Pharmaceutical Co., Ltd. |
CEO | Lim Jong-yoon |
General Manager | Lim Hae-ryong |
Founding Date | March 27, 1996 |
Business Address | No. 10 Tianzhu West Road, Tianzhu Airport Industrial Zone A, Shunyi District, Beijing, China |
Revenue | KRW 402.4 billion |
Number of Employees | 1,230 employees |
Main Business | Main business : Manufacturing and sales of pharmaceuticals and new drug development |
Shareholder Composition Status | Hanmi Pharmaceutical Co., Ltd. (73.68%), China Resources Zizhu Pharmaceutical Co., Ltd. (26.32%) |
Beijing Hanmi Pharmaceutical Board of Directors
Composition | Chairman : 1 person, Directors : 5 people |
Diversity of Directors | 5 men, 1 woman |
Term of Office for Directors | 3 years |
Nationality | South Korea 4 people / China 2 people |
Prevention of Conflicts of | Members of the Board of Directors must disclose to the Board all situations that may give rise to conflicts of interest and must be subject to deliberation in connection therewith. This includes potential stages where the conflict of interest has not actually occurred. In this regard, the review of the current status of the Board of Directors revealed no conflicts of interest. |
Regarding | As the company's highest decision-making body, the Beijing Hanmi Pharmaceutical Board of Directors determines important matters for the company, including the establishment of strategic directions, supervision of company management, protection of shareholder rights, election and dismissal of executives, approval of financial reports and business plans, and establishment of key management systems, through regular and extraordinary meetings in accordance with the articles of association, to ensure the company's continuous and stable growth. |
Performance Evaluation & Compensation of the BOD | The Beijing Hanmi Pharmaceutical Board of Directors conducts an annual performance evaluation of its activities, and the compensation for its directors is calculated based on long-term management performance operational standards reflecting G&P. The final amount is determined through adjustment by the legal representative and then disclosed annually through the audit report. |
Key Certifications Status
Certifications | Certifying Authority and Country |
|---|---|
GMP Certification by Formulation Type | China Food and Drug Administration (CFDA) |
High-tech Enterprise Certification | Beijing Municipal Science and Technology Commission |
AEO CERTIFICATE | Beijing Customs of the People's Republic of China |
Beijing Foreign Investment Research Center Certification | Beijing Municipal Science and Technology Commission |
Permit for Laboratory Animal Use | Beijing Municipal Science and Technology Commission |
International Management System (ISO) Certification Status
Category | Content | Period |
|---|---|---|
ISO 14001 | Environmental Management System | 2024.03.22 ~ 2027.03.21 |
ISO 45001 | Occupational Health and Safety Management System | 2024.03.22 ~ 2027.03.21 |
ISO 37001 | Anti-Bribery Management System | 2025.01.25 ~ 2028.01.24 |
Subsidiary | Hanmi Fine Chemical
Based on over 40 years of accumulated R&D capabilities and production technology, we have obtained cGMP certification from regulatory bodies in major developed countries such as the United States, Europe, and Japan. Through a stable quality management system, we supply products to over 30 countries, growing into a trusted partner in the global pharmaceutical industry.
Since its establishment, Hanmi Fine Chemical has secured competitiveness in the cephalosporin antibiotic field. We have expanded into the general generic API business, leveraging highly complex synthesis technology and ultra-high purity quality in non-cephalosporin product areas. We are also continuously investing in discovering future growth engines by securing technological competitiveness in next-generation pharmaceutical fields, including the development of PEG and mRNA Capping. Through these efforts, we are promoting a shift towards a high-value-added business structure that includes CDMO, beyond just the generic API business.
Based on our management philosophy of 'Respect for Humanity' and 'Value Creation,' we are dedicated to growing into a global active pharmaceutical ingredient (API) company trusted by customers and society through responsible production activities and continuous research and development.
Company Name | Hanmi Fine Chemical Co., Ltd. |
CEO | Lim Jong-hoon, Jang Yeong-gil |
Founding Date | February 22, 1984 |
Business Address | 57 Gyeongje-ro, Siheung-si, Gyeonggi-do (Jeongwang-dong) |
Revenue | KRW 91.3 billion |
Number of Employees | 261 employees |
Main Business | Main Business Activities : Manufacturing and sales of active pharmaceutical ingredients (APIs) and development of new synthesis technologies for novel drugs |
Shareholder Composition Status | Hanmi Pharmaceutical Co., Ltd. (63.0%), Institutional and Individual Investors (37.0%) |
Hanmi Fine Chemical Board of Directors
The Board of Directors of Hanmi Fine Chemical is composed of professional managers with rich experience and specialized knowledge in various fields, handling important decision-making matters of the company, proactively preventing various potential risks, and conducting self-assessments of the management's performance.
Composition | 4 Executive Directors, 1 Non-Executive Director, 1 Auditor |
Diversity of Directors | 6 Men / 0 Women |
Term of Office for Directors | 3 years |
Prevention of Conflicts | Hanmi Fine Chemical adheres to the rules on board ethics under the same conditions as Hanmi Pharmaceutical's regulations. Accordingly, directors are required to “notify the Board of all situations that may give rise to conflicts of interest and refer them for deliberation.” |
Regarding | Hanmi Fine Chemical strives to overcome potential risks and create economic, social, and environmental value through communication with stakeholders. Through fair internal audits, we are improving problematic practices and inefficient structures, strengthening our systems to enable company growth through more transparent management. Furthermore, for effective risk management, we are establishing an integrated crisis response management governance that encompasses everything from top management to field organizations. We periodically review and respond to risk situations to prevent major risks and enable prompt countermeasures. Based on the risk management process, we are conducting simulations for each major risk and making company-wide efforts to review and enhance our crisis response capabilities. |
Board Performance Evaluation and Compensation | The Board of Directors of Hanmi Fine Chemical conducts a regular evaluation of its performance annually. Compensation for the Board is calculated based on the same short-term incentive operating standards as Hanmi Pharmaceutical, and the final amount is determined through CEO adjustments and paid within the scope resolved by the general meeting of shareholders. |
Key Certifications Status
Certifications | Certifying Body |
|---|---|
BGMP Certification | Ministry of Food and Drug Safety |
Acquisition of Certificate of Suitability (CEP) to the European Pharmacopoeia | European Directorate for the Quality of Medicines & HealthCare (EDQM) |
GMP Compliance Certification for Injectable Manufacturing Facilities | Portuguese Ministry of Health (Infarmed) |
GMP Audit and cGMP Compliance | U.S. Food and Drug Administration (US FDA) |
Acquisition of EU GMP Certification for General Plant (Production Building C) | German Federal Ministry of Health (BSG) |
GMP Audit and Acquisition of GMP Certificate | Australian Therapeutic Goods Administration (TGA) |
Obtained GMP audit and compliance certification | Japan's Ministry of Health (PMDA) |
cGMP compliance re-certification | U.S. Food and Drug Administration (US FDA) |
Obtained GMP audit and compliance certification | Mexican Federal Commission for the Protection against Sanitary Risk |
International Management System (ISO) Certification Status
Category | Content | Period |
|---|---|---|
ISO 14001 | Environmental Management System | 2025.06.03 ~ 2028.06.02 |
ISO 45001 | Occupational Health and Safety Management System | 2025.05.20 ~ 2028.05.19 |
ISO 22301 | Business Continuity Management System | 2025.12.29 ~ 2028.12.28 |