HomeA state-of-the-art GMP plant compliant with international standard guidelines (PIC/S).
Concept design began in February 2023 and construction started in June 2024, with final approval obtained on August 1, 2025.
Approximately 35,000 people were mobilized during the project period, with the GMP plant (B1, 5F) completed in July 2025.
For solid dosage forms, a BIN System was adopted to minimize exposure,
with production capacity established at 800 million tablets/year and 200 million
capsules/year. For injectables, an automated CIP/SIPSystem meeting EU-GMP
Annex 1 standards was adopted together with PUPSIT, freeze-dryer automatic
loading/unloading devices (ALUS), and O-RABS. Two vial lines (including 3
freeze-dryers) were built with capacity of 14.4 million vials/year (liquid) and
21.6 million vials/year (freeze-dried), plus one ampoule line (21.6 million
ampoules/year). A large-scale GMPfacility has been completed, laying the
foundation for Daehan Nupharm’s second leap forward.
B1, 5 floors above ground
- RF
- Cooling tower, CDU, air handling units, dustcollectors, etc
- 5F
- Solid dosage packaging line, HVAC rooms, water treatment, compressed air facilities
- 4F
- Solid dosage production lines (mixing, tableting, coating, sorting)
- 3F
- Injectable packaging line, HVAC rooms
- 2F
- Injectable production lines (Vial+Freeze1,Vial+Freeze2, Ampoule)
- 1F
- Storage (raw materials, materials, finished products),power generation room, substation, HVAC rooms
- B1F
- Machinery rooms (boiler, refrigeration, firefighting,etc.)
- Reflecting BIN System
- Tablets: 800 million tablets/year
- Capsules: 200 million capsules/year
- AUTO CIP/SIP System, PUPSIT, Automated Foreign Matter Inspection System
- Vial: 14.4 million vials/year (6x current capacity)
- Freeze-dried: 21.6 million vials/year (3x current capacity)
- Ampoule: 21.6 million ampoules/year (3x current capacity)
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Concept Design
Feb 2023–Jun 2023 (delivered Oct 2023) -
Detail Design
2023.07~2024.03 -
Building Permit
May 2024 (construction permit Jun 2024, demolition permit Jun 2024) -
Construction Period andWorkforce
Groundbreaking Ceremony for Second Plant: May 17, 2024
Construction Period: Jun 2024–Jul 2025 (14 months)
Workforce: Total workforce of 35,000 man-days
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Target GMP Approval
2026.08~11
