For more detail information do send us a mail on :orglab2@dongbangchem.co.kr

Research and Development

Under the Philosophy of promoting human happiness and health, DongbangFTL is conducting excellent research and unique development of high purity, high-quality APIs. We are focusing on polymorphism such as new crystalline form, pseudo-polymorph, co-crystals to improve the stability, efficacy, solubility, etc. of APIs. To increase the reliability of our products, we are developing analytical methods of intermediates and APIs. And we are also working on the control of impurities and potential genotoxic impurities for our products. In addition, In addition, Dongbang FTL has expertise in scale-up processes by scientific approaches including CMO(Contract Manufacturing Organization) and CDMO(Contract Development & Manufacturing Organization)

We are Developing various crystalline types such as carbs, salts, co-crystals, and many more to improve the stability, efficacy expression rate, solubility, etc. of raw materials and we are developing qualitative/ quantitative methods of starting materials, intermediates, and raw material drugs to increase the reliability of our products and we are also working on the control and removal of impurities and genetically toxic impurities from the synthesis process.

In addition,DongbangFTL conducts research on new compounding methods for meeting market demand, reducing costs, and manufacturing high-purity raw materials, and commercial scale.

Processes suitable for mass production at the request of customers, conducts research on the commercial-scale process and at the request of customers, CMO(Contract Manufacturing Organization, Consignment Production) and CDMO(Contract Development & Manufacturing Organization, Consignment Development)

Our Core Technology

  1. Scale-up Technology

    Key Process Parameter management, safety, and economics that can affect quality are minimized by systematic management from Lab-scale.

  2. Purification Technology

    Development of new crystalline form and patent-free crystalline form

    Related technologies : New manufacturing method β crystals of Silodosin, development of amorphous Apixaban, development of Ipragliflozin co-crystal.

  3. Analytical Technology

    Development of optimized analytical methods for the management of Impurity with validation.
    Development of anaytical methods to manage genotoxic impurity using LC/MS/MS and GC/MS/MS.

  4. Synthetic Technology

    Developing variety of economical, eco-friendly and safe synthetic methods Various Synthetic Technologies:

  5. Other Technology

    Establish a systematic genetoxicity evaluation based on commertical database.
    Patent analysis and patent strategy established by database and experts.

API Agenda

Generic APIs (Active Pharmaceutical Ingredients) contain the same chemical substance as a drug that was originally protected by chemical patents. We are Developing various crystalline types such as carbs, salts, co-crystals and many more to improve the stability, efficacy expression rate, solubility, etc.

Product Name LAB Pilot PV DMF
Apixanban Completed Completed Completed In Progress
Edoxaban Completed Completed 2022.1H 2022.2H
Empagliflozin Completed Completed 2022.1H 2022.2H
Iparagliflozin Completed Completed 2022.1H 2022.2H
Macitentan In progress 2022.1H 2023.2H 2024.1H
Lacosamide Completed Completed 2022.2H 2022.2H
Iraprazole In Progress 2021.2H 2022.1H 2022.2H
Lafutidine Completed Completed Completed In progress
Riociguat In Progress 2023.1H 2024.1H 2024.2H

Patents





DongbangFTL employees work very hard and we have achieved alot of patents. List of API's Sitagliptin phosphate monohydrate, Sitagliptin phosphate anhydrous, Vildagliptin, Azelnidipine, Rivaroxaban Apixanban, Edoxaban, Empagliflozin, Ipragliflozin, Macitentan, Lacosamide, Iraprazole, Lafutidine, Riociguat.

Equipments for analysis





The analytical lab types of equipment or instruments are used in analytical applications in pharmaceutical, Drug laboratories, chemical, clinical, and API factories. This lab equipment or instruments help in analyzing materials and setting up the composition.




R&D Organization



R&D Organization

  1. Research Planning Team

    Key Process Parameter management, safety, and economics that can affect quality are minimized by systematic management from Lab-scale.

  2. Analytical Research Team

    Development of new crystalline form and patent-free crystalline form

    Related technologies : New manufacturing method β crystals of Silodosin, development of amorphous Apixaban, development of Ipragliflozin co-crystal.

  3. Process Research Team

    Study on kilo-lab scale-commercial scale optimization process CQA(Critical Quality Attribute) setting.

  4. Synthesis Research Team

    API synthetic process development and optimization in lab scale-kilo scale with high quality and high standards.

Research

Research Planning Team

Research

Research Planning Team

Research project progress, evaluation Responsible for planning and management related to research

Research

Analytical Research Team

Research

Analytical Research Team

Drug substance test method development (Validation) Drug regulatory agency license registration.

Research

Process Research Team

Research

Process Research Team

Study on kilo-lab scale-commercial scale optimization process CQA(Critical Quality Attribute) setting.

Research

Synthesis Research Team

Research

Synthesis Research Team

API synthetic process development and optimization in lab scale-kilo scale with high quality and high standards.