South Korea tightly regulates the manufacture of controlled substances. Any company producing narcotics or psychotropic substances must hold a Narcotics and Psychotropic Substances Manufacturer (마약류제조업) license.
What qualifies as “narcotics and psychotropic substances” in Korea?
This category—under the Narcotics Control Act—includes narcotics, psychotropic substances, and cannabis (for medical/industrial use where permitted).
Which businesses require this manufacturing license?
Any entity that manufactures, prepares, processes, or subdivides narcotics or psychotropic substances in Korea must obtain this license from the Minister of Food and Drug Safety (MFDS). Item-level product approval/permission is also required. The Minister may restrict or deny manufacturing based on factors such as domestic demand, duplication, or dependence risk.
How this differs from “drug” manufacturing
Drug (medicinal product) manufacturing is governed by the Pharmaceutical Affairs Act and covers products like tablets, injections, and vaccines. Narcotics/psychotropics add stricter controls—secure storage and access, inventory reporting, a designated safety manager, and item-level permissions. Holding a general medicinal-product license does not grant authority to manufacture narcotics. For details on drug manufacturing, see Medicinal Product Manufacturer License (의약품제조업).
Key obligations (high level)
- Secure facilities & access control (vaults/locks/CCTV; restricted personnel access)
- Inventory tracking & electronic reporting, including timely loss/theft notifications
- Designated Narcotics Safety Manager and documented SOPs
- Quality/GMP controls appropriate to dosage-form manufacture
What does the license indicate about the business?
It confirms the company is legally authorized to produce controlled substances and that its facilities, security systems, record-keeping, and quality controls meet MFDS requirements. It also indicates that product-level permissions have been granted and that the firm is subject to ongoing inspections and reporting—signaling a high level of compliance and operational rigor.
Coverage in KOBDi: The KOBDi database includes businesses registered with a Narcotics and Psychotropic Substances Manufacturer (마약류제조업) license. This information appears on each Business Profile page, and companies with this license can be found via the KOBDi Korea Industry Search.