Dong-A ST

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Plant

Dong-A ST Quality Management System

Dong-A ST guarantees consistent product stability by strictly adhering to GMP standards at every stage— from raw material sourcing to production and final shipment.
Before shipment, we conduct comprehensive inspections to detect and address any potential issues, ensuring the highest level of product safety for our customers.

Our quality management system is aligned with the latest global GMP regulations, reflecting our unwavering commitment to delivering top-quality pharmaceuticals.
Quality
Management

Quality management control

Product complaint and recall
management

Incident and CAPA management

Training and education management

Quality risk management (QRM)

Data integrity management

Manufacturing
Process Control

Manufacturing site, sanitation,
and environment management

Validation management

Manufacturing process
management

Manufacturing equipment
management

System
Enhancement

Operation of GMP IT systems
(StarLIMS, MES etc.)

Introduction of automated/
digitalized systems

Quality by Design (QbD)

Vendor
Audit

Evaluated raw material suppliers

Evaluated CMOs

Evaluated imported drug suppliers

Cheonan Campus
Our Cheonan campus is KGMP-certified for all manufacturing processes, and manufactures tablets, capsules,
and injectable products under strict GMP compliance and quality control.
Certifications
2014.04
PMDA(Japan)
2016.06
INVITE (Columbia)
2016.11
WHO
2019.01
ANVISA
2014.04
MFDS
2016.06
ISO 14001
2016.11
ISO 45001
2019.01
ISO 50001
Products
Tablets

Motilitone

Opalmon

Sugamet XR

Capsules

Closerin

Onon

Newrica

Injections (General, Oncology)

Gaster

Cisplan

Perdipine

Daegu Campus
Our Daegu Campus is located in the Dalseong Industrial Complex in Daegu and specializes in the production of biopharmaceuticals.
All manufacturing processes at the campus are KGMP-certified and ensure the highest quality.
Certifications
2015.06
INVITE (COLOMBIA)
2016.12
NAFDAC (NIGERIA)
2017.08
MOH (PAKISTAN)
2019.10
MOH (TURKEY)
2021.06
MFDS
2021.06
ISO 14001
2021.06
ISO 45001
2022.12
ISO 50001
Products
Injector Pens

Growtropin

Vials

Growtropin

Leucostim

PFS

Eporon

Gonadopin

Dulastin

Songdo Campus
Our Songdo Campus was completed in 2022 as a tablet-dedicated plant.
It is equipped with cGMP facilities and quality systems for global production of novel drugs.
GMP IT System
IT Systems Implemented at the Songdo Campus

Our Songdo Campus is implemented with an IT system that is compliant with cGMP and Data Integrity regulations.

Products Scheduled for Production
Tablets

Suganon

Stillen

Sugamet XR

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