PIC/S GMP

Osong GMP Factory

Osong GMP factory is a strategic production base that will lead Nexpharm Korea to a global pharmaceutical company.
It was newly designed and constructed according to the international GMP guidelines to obtain approvals from the authorities of advance countries.

Osong factory is a state-of-the-art factory equipped with the latest facilities at cGMP level having production competitiveness with higher quality to produce world-class oral solid preparations i.e., tablets, capsules, granules, powders and oral liquids.

Major operation systems

  • Water treatment system

    The water used in the pharmaceutical production is highly purified water according to the cGMP standard and it is manufactured through the water treatment system using activated carbon filter, reverse osmosis filter, etc. and it is supplied for each process line through the completely sealed special piping.

  • Air conditioning system

    The clean air which has been passed through several stages of clean filters is supplied to the whole production lines including the inventory rooms after passing through the heating and cooling devices.
    The inside of the factory is divided into Class 100 ~ 100,000 by zone, and the cleanliness is controlled under the cGMP standards.
    Also, air density and pressure is automatically adjusted in passageway and work room to prevent cross-contaminations by preventing the dusts inside the work room from being pushed out.

  • BMS(BUILDING MANAGEMENT SYSTEM)

    Osong GMP plant is an ‘Intelligent Plant’ so that and all major facilities, i.e., water treatment system and air conditioning system are automatically controlled and operated..

    • Air conditioning monitoring
    • Water treatment monitoring
    • Power monitoring control (Uninterruptible power system)
    • Environmental Monitoring: Worksite humidity, differential pressure, particle, wind velocity

Production capabilities

Preparation Tablet Capsule Granules & Powders
Capacity 700 Mil. Tab./Year 200 Mil. Cap./Year 13 Mil.Sachet/Year

Oral solids are produced using the latest equipment such as Bin Mixer, Fluid Bed Spray Granulator, and Rotary Tablet Machine.
※ Oral solids: Tablets, Capsules, Granules, Powders
※ Oral liquids

Core production technology

Core production technology of Nexpharm Korea is Micro Particle Coating using Fluid Bed Spray Granulator.
This technology makes oral delivery system or DDS (Drug Delivery System) technology possible.

  • FLUID BED SPRAY GRANULATOR

    From small volume to mass production

    It is able to develop customized products with the production equipment suitable for small quantity production for clinical trial medicines and for mass production either.

  • MULTI-LAYERED TABLETING MACHINE

    Multi-layered tableting Machine

    Multi-layered tablet is made up of two to four layers, each of which can have a different release profile and API. It is used for the development of incrementally modified drugs and/or combination new drugs which require advanced pharmaceutical technology as well as production facilities.

  • INSPECTION SYSTEM

    Through the whole production processes, Bin System and Vacuum transfer System are basically applied to minimize external exposure of all semi-finished products during the production process. Also, in the selection process, which is the final stage of production, automatic selection equipment with 12 cameras can select more than 200,000 units per hour.

  • Production Support Equipment

    In order to achieve superior quality, Nexpharm Korea has used advanced analysis equipment to perform the perfect production processes according to international standards from ingredients analysis, in-process control, strict quality control of finished products, to post-stability test after commercialization.