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Anseong Plant

안성공장 외부 이미지

Ildong Pharmaceutical’s manufacturing facility in Anseong was the first such facility in the country to acquire the KGMP certification for all its processes and currently combines the latest production equipment with strict GMP standards to manufacture drug products of the highest quality.

The facility consists of separate cephalosporin antibiotics and cytotoxic anticancer agents manufacturing buildings that are compliant with international GMP standards and utilizes the one-line system, the restricted access barrier system, the building management system, the automated warehouse system, and other advanced manufacturing solutions to prevent contamination at its roots, create the most optimal environment for manufacturing pharmaceuticals, and ensure the manufacture of defect-free drug products. The cephalosporin antibiotics building and cytotoxic anticancer agents building are capable of producing approximately ₩150 billion and ₩50 billion’s worth of products each year, respectively, and constitute key elements of Ildong Pharmaceutical’s global expansion strategy.

Anseong Facility’s Key Products

General facility
  • Solids : Aronamin Gold Tablet, Curan Tablet, Biovita Granule, and others
  • Injectables : Ativan Injection, Curan Injection, and others
Cephalosporin Antibiotics
  • Solids : Flomox Tablet, Cefaclor Capsule, and others
  • Injectables : Flumarin Injection and others
Cytotoxic anticancer agents
  • Solids : Xelobig tablet, Temolam capsule, etc.
  • Injectables : Flumarin Injection and others

Location

  • Address
    25, Gongdan 1-ro, Anseong-si, Gyeonggi-do, Republic of Korea
  • Telephone
    +82(31)673-1701
  • Facsimile
    +82(31)673-4860

Ildong Pharmaceutical’s manufacturing facility in Anseong combines modern production equipment with strict GMP standards enforced by teams of skilled professionals on per-drug-type and per-process basis to ensure the manufacture of products of the highest quality.

The facility is divided into an injectables building, an internal-solids building, and an administrations and logistics building and operates separate manufacturing areas for products containing lactobacillus bacteria and products containing crude drugs. Furthermore, anterooms have been installed at the entrances to internal-solids preparation, tableting, coating, and filling areas to prevent cross-contamination.

이 표는 안성공장 일반제공장 소개 목록을 나타내는 표로 건물명칭/면적, 준공, 특징, KGMP승인, 식약처 PIC/S GMP로 구성되어 있습니다.
Building General facility(Building G)
Building Area 25,101㎡
Completion 2013
Features
  • - Advanced automation system
  • - Expert personnel
  • - State-of-art operations management system
  • - Stable manufacturing process
  • - Flawless quality assurance
  • - Separate manufacture of OTC solids and lactobacillus products
  • - Anterooms to prevent cross-contamination
KGMP Approval Revised approval in Dec 2013 (injectables and internal solids)
MFDS PIC/S GMP Compliance 31 August 2016

Manufacturing Capacity

Freeze-dried Inejctables
18,250,000 vials
Liquid Injectables
73,600,000 vials
Ampule Injectables
94,600,000 ampules
Tablets
11,300,000,000 tablets
Capsules
2,500,000,000 capsules
Granules
660,000 kg

Floor by Floor

이 표는 층별안내 목록을 나타내는 표로각 층의 주사제동 (G1), 내용고형제동 (G2), 사무물류동 (G3) 비고로 구성되어 있습니다.
Floor Injectables Building (G1) Internal Solids Building (G2) Administrations & Logistics Building (G3)
3 HVAC HVAC Quality Management
2 Injectables Preparation Area Raw Materials Storage Internal Solids Preparation Area Office Conference Room
1 Injectables Packaging Internal Solids Packaging Raw Materials Storage Finished Products Storage

Manufacturing

Ildong Pharmaceutical’s manufacturing facility in Anseong combines advanced and modern manufacturing solutions rivaling those of some of the most recognized names in the pharmaceuticals industry with strict GMP standards implemented per product type and per process by a staff of experts to manufacture pharmaceuticals of the highest quality. The facility also practices production-innovation protocols known as 5S and TPM and is constantly striving to achieve increasingly higher levels of product quality and manufacturing productivity.

Quality Management

From sourcing raw materials to manufacturing and packaging finished products, Ildong Pharmaceutical’s manufacturing facility in Anseong strictly adheres to GMP standards and performs internally developed inspections and tests through the hands of trained and experienced quality-control personnel and using the latest equipment to ensure consistent levels of quality, efficacy, and stability in all its products. The facility’s personnel also include a separate quality-assurance team responsible for validating manufacturing processes and quality tests and for administrating a quality-enhancement system.

Quality Management in Compliance with International Standards
Ildong Quality System
EU CMP
KGMP
ICH Guidelines
PIC/S Guidelines

Support System & Environmental Management

01

The facility includes four separate areas for storing raw materials, supplies, and finished products (5,000 cells in total) and utilizes
advanced systems to separate and store the materials, supplies, and products without any cross-contamination.

02

An advanced system for managing the quality of water used at the
facility has also been incorporated to maintain even higher water quality
than required and prevent chemical byproducts from entering the nearby
waterways or the atmosphere.

Through the use of advanced solutions and a strong sense of
responsibility for the preservation of the environment,
Ildong Pharmaceutical continues to serve as a steward in charge
protecting the environment for future generations.

The cephalosporin antibiotics building is where freeze-dried injectables, powdered injectables, internal solids, capsules, dry syrups, and other types of drugs are manufactured.

The building features two freeze-drying units capable of manufacturing 120,000 vials simultaneously and a manufacturing system approaching full automation, achieving unmatched levels of productivity and quality. The building also features an ERP system, a BMS (Building Management System), and an automated warehouse to achieve the most optimal environment for manufacturing pharmaceuticals.

이 표는 안성공장 항생제공장 소개 목록을 나타내는 표로 건물명칭/면적 ,기계설치 ,준공, 특징, KGMP승인 ,식약처 PIC/S GMP Compliance 으로 구성되어 있습니다.
Building Cephalosporin antibiotics facility(Building C)
Building Area 7,587㎡
Machinery Installation December 2009
Completion November 2009
Features
  • - Capable of manufacturing numerous formulation types
  • - An automated freeze-dried injectables manufacture line with the largest capacity in the country
KGMP Approval Revised approval in July 2015 (injectables and internal solids)
MFDS PIC/S GMP Compliance 14 July 2015

Manufacturing Capacity

Freeze-dried Injectables
11,000,000 vials
Powdered Injectables
37,000,000 vials
Tablets
500,000,000 tablets
Capsules
660,000,000 capsules
Dry Syrups
650,000 kg

Floor by Floor

이 표는 층별안내 목록을 나타내는 표로 층, 구분, 제형, 면적㎡으로 구성되어 있습니다.
Floor Category Formulation Type Area (㎡)
Rooftop HVAC 874
3 Solids Tablets Capsules Dry Syrups 1,773
2 QC/QA 818
1 Automated Warehouse Cafeteria Freeze-dried Injectables Powdered Injectables 2,312
Basement Water Reservoir, Transformers, Generators, and Water-Treatment System 1,902

Features

Cephalosporin Injectables
  • Complete one-line automation from vial washing to packaging
  • Contamination-proof filling, freeze-drying, and capping via RABS
  • Auto-loading of vials onto freeze-driers after filling
  • Vial exterior cleaning to eliminate contamination during the manufacture process
Cephalosporin Solids
  • Systems for manufacturing tablets, capsules, and dry syrups
  • Weighing cabinets to prevent cross-contamination during weighing
  • IBCs and automated washers to prevent cross-contamination
  • Use of air-jet mills for greater manufacturing efficiency and throughput

The anticancer drugs building at Ildong Pharmaceutical’s manufacturing facility in Anseong is the country’s first independent cytotoxic chemotherapeutic agents facility capable of producing both injectables and solids.

The building features fluid-bed granulators capable of mixing, combining, assembling, and drying in a single line, is designed to fully contain cytotoxic substances within the facility, and utilizes airtight bins throughout the entire manufacturing process to prevent airborne contamination.

이 표는 안성공장 항암제공장소개 목록을 나타내는 표로 건물명칭/면적 ,기계설치 ,준공, 특징, KGMP승인 ,식약처 PIC/S GMP Compliance 으로 구성되어 있습니다.
Building Cytotoxic anticancer agents facility(Building A)
Building Area 2,344㎡
Machinery Installation December 2009
Completion November 2009
Features Manufacture of cytotoxic chemotherapeutical agents in internal solid and injectable formulations
KGMP Approval September 2010 (injectables)
September 2011 (internal solids)
MFDS PIC/S GMP Compliance 14 July 2015

Manufacturing Capacity

Freeze-dried Injectables
550,000 vials
Liquid Injectables
30,000,000 vials
Tablets
100,000,000 tablets
Capsules
300,000,000 capsules

Floor by Floor

이 표는 층별안내 목록을 나타내는 표로 층, 구분, 제형, 면적㎡으로 구성되어 있습니다.
Floor Category Formulation Type Area (㎡)
Rooftop HVAC 390
2 Solids Tablets and Capsules 314
1 Injectables Warehouse Freeze-dried Injectables Liquid Injectables 1,378
Basement Water-Treatment System 87

Features

Personnel Protection from Cytotoxic Substances
  • Dust-Collection System
  • Enclosed Weighing Station
  • Protective Headgear and Clothing
State-of-Art Manufacturing Equipment
  • Fully Automated Vial-Production Line
  • Aseptic Clean Carts
  • Wet Granulator
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