A state-of-the-art GMP plant compliant with international standard guidelines (PIC/S)
The concept design commenced in February 2023, followed by the start of construction in June 2024. The GMP facility,
consisting of one basement level and five above-ground floors, received completion approval on August 1, 2025.
The solid dosage line incorporates a BIN system designed to minimize material exposure.
The injectable line is equipped with a fully automated CIP/SIP system, a PUPSIT freeze dryer automatic loading/unloading system (ALUS),
and an O-RABS, all configured to ensure full compliance with EU-GMP Annex 1 requirements.
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.)

(OSD)
800 million tablets/year
200 million capsules/year
Incorporation of a BIN system designed to minimize material exposure.

14.4 million vials/year
Freeze-dried 21.6 million vials/year
Installation of a fully automated CIP/SIP system,
a PUPSIT freeze dryer automatic loading/unloading
system (ALUS), and an O-RABS to ensure compliance
with EU-GMP Annex 1 requirements.
-
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
-
Target GMP Approval
2026.08~11


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