동아ST

Dong-A ST

DONG-A ST is advancing toward becoming a global pharmaceutical leader.

Manufacturing services

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

제품정보
R&D
파이프라인
사업분야
인재채용
IR 자료실
사업관계자
CP
CLEAN :D
PRM
DCMS

DMB-3115 Data Protection Notice

Last Edited on [2023-05-02]

This Privacy Notice describes the personal data that Dong-A ST Co., Ltd. (hereafter “Dong-A”, “us”, “we”, “our”") collects through our website located at http://en.donga-st.com/Main.da that are specific to our product coded DMB-3115 in relation to all clinical trials and regulatory approvals in Europe and how we use and keep safe that information.

Dong-A as the Controller of the personal data has committed to comply with the General Data Protection Regulation N°EU 2016/679 (hereinafter, the "GDPR") and all EU applicable laws and regulations regarding data protection collectively referred as "Data Protection Laws". In compliance with the GDPR, we appointed Data Protection Officer listed below who performs his or her the tasks as required by the GDPR.

With this Privacy Notice, Dong-A aims at ensuring that you understand what personal information is collected about you, how your personal information is used and how it is kept safe.

GENERAL WARNING AND USE OF SOCIAL MEDIA

Access to the Website implies the User’s full and unreserved acceptance of this Privacy Notice (hereinafter the “Notice”), as well as its general terms of use. The User acknowledges having read the information below.

The Notice is valid for all pages hosted on the Website. It is not valid for the pages hosted by third parties to which we may refer and whose privacy notices may differ. Dong-A cannot therefore be held responsible for any data processed on these websites or by third parties. This Notice also applies to any other website that Dong-A may operate.

1. Why, how and for how long do we collect your personal data?

We will only process your personal data in connection with specific purposes. We will keep them for no longer than necessary to fulfill the purposes for which we collected it, including any legal requirements.

Depending on each case, the processing will therefore be as follows:

Purposes	Types of personal data	Legal basis	Retention period
To answer to your queries	Name, email address, Please note that other Personal Data may be processed by Dong-A depending on your request and the information you provide us.	This processing is based on our legitimate interest in answering the requests or queries raised by you through the existing different contact channels We understand that the processing of these data is also beneficial to you to the extent that it enables us to assist you adequately and answer to the queries raised.	We will process your data for the time necessary to meet your request.
For statistical purposes	Aggregate statistical data	We consider that we have lawful interest to understand the way our page is consulted (e.g., how many times our page is consulted, from which country, etc.).	We may export statistical reports, but we guarantee that this is only in an anonymous form.

2. Data sharing

We do not sell or trade your personal data to third parties.

However, Dong-A has contracted with the following Services Providers to manage the Website that may have access to your personal data:

- DA Information for Hosting.

Sharing your personal data as explained above may involve a transfer of personal data to a country outside the European Economic Area (EEA), we are therefore committed to complying with the transfer rules under applicable Data Protection Laws and therefore ensure to:

• Transfer your data to countries where the data recipient is located that has been recognized as adequate by the European Commission; or

• Where a country has not received an adequacy decision from the European Commission, to implement appropriate safeguards, such as the EU Standard Contractual Clauses ("SCCs").

You can contact our DPO (see contact details below) if you want to have more details about the mechanism supporting data transfer.

3. How do we protect your information?

We process your personal data in a confidential manner and provide a sufficient and adequate level of protection of your personal data.

Your personal data is housed behind secured networks and are only accessible by a limited number of persons who have special access rights to such systems and are required to keep the information confidential.

4. Your rights

According to the GDPR, you have the following rights:

- Access. You have the right to obtain confirmation as to whether or not personal data concerning you are being processed, and, where that is the case, information related to the processing of data and a copy of the data being processed.

- Rectification. You have the right to require rectification of inaccurate data about you.

- Right to be forgotten. To obtain the deletion of your personal data in the situations set forth by applicable data protection law.

- Restrict processing. You have the right to restrict processing of data under certain specified circumstances.

- Rectification. You have the right to require rectification of inaccurate data about you.

- Data portability. You have the right to request for the receipt or the transfer to another organization, in a machine-readable form, of your personal data.

- Object to processing. You have the right to object, on grounds relating to your particular situation, at any time to the processing of your data.

- Right to withdraw consent. When you have given your explicit consent for the processing of your data (e.g., Subscription to the Newsletter), you can withdraw it at any time without justification.

Please note that all these rights are not absolute and will be assessed on a case-by-case basis by our Data Protection Officer (DPO).

If you would like to exercise your rights, please let us know by contacting our DPO at dong-a.dpo@mydata-trust.info.

You have also the right to lodge a complaint if you consider that your personal data is not processed in accordance with the GDPR.

If you are an EEA resident: You have the right to lodge a complaint with the Data Protection Authority in the Member State of the European Union of your habitual residence, place of work or place of the alleged infringement.

Please find the contact information of all Authorities in section 6 "Contacts".

5. Changes to this Privacy Notice

This Notice is effective as of the date stated at the top of this page. We may change this Notice from time to time. Please refer back to this Notice on a regular basis.

6. Contacts

If you have any questions or comments about this Notice or our practices regarding your personal data, please contact us.

Dong-A ST Co. Ltd., acting as Controller

64, Cheonho-Daero, Dongdaemun-Gu

Seoul 02587, Republic of Korea

email: st_ciso@donga.co.kr

telephone: +82 2 920 8254

Data Protection Officer

MyData-TRUST SA

Boulevard Initialis, 7 bt 3 – 7000 Mons (BELGIUM)

For EU Data Protection Authorities

https://edpb.europa.eu/about-edpb/about-edpb/members_en