메인메뉴 바로가기

All Menu

About Us Business & Products R&D new products/R&D Plants & Quality Careers News

Hanmi Fine Chemical.Co.,Ltd.

글로벌메뉴

메인메뉴


HomePlants & QualityManufacturing Facilities

Plants & Quality

Manufacturing Facilities

Specialized API Manufacturer,
Guaranteeing World’s Top Quality

Hanmi Fine Chemical is equipped with API production facilities that satisfy the cGMP regulations as well as cephalosporin API manufacturing plant and general API manufacturing plant with the latest equipment and facilities.

We have acquired compliance certifications through field inspection by the overseas health departments such as the US FDA, EU EMA, PMDA of Japan, BGV of Germany and TGA of Australia in recognition of our manufacturing facilities and quality control system that conform to the GMP standards such as KGMP, US cGMP and EU-GMP.

We are equipped with the latest API production facilities with production capacity of 300,000L. Vendor audits were conducted on the cephalosporin API manufacturing plant after 1997 and general API manufacturing plant after 2007, and the results demonstrated their conformance with the audit acceptance criteria.

Cephalosporins APIs

  • Production Building A-1: Sterile cephalosporin APIs
  • Production Buildings A-2 & B: Cephalosporin APIs and intermediates
  • Building Area: 9,637㎡
  • Production Reactor: 80,000L
  • Production Filter & Dryer: 34,900L
Aseptic Facilities
  • Outstanding facilities that comply with cGMP and produce high quality products
  • Completeness of sterile processes through SIP & CIP
  • Conformance with sterile process standards with qualified workers
  • Training of outstanding professionals through continuous education based on GMP

일반(General APIs)

  • Production Building C: General APIs and intermediates
  • Building Area: 12,335㎡
  • Production Reactor: 205,000L
  • Production Filter & Dryer: 30,400L
Manufacturing Facilities
  • Diverse production reactors with 300,000L capacity
  • Glass lining, Stainless steel, Hastelloy C-22
  • Filtering and drying device with 65,000L capacity
  • Filter Dryer, Nutsche Filter, Double Con Vacuum Dryer, Vacuum/Convectional Dryer
Key Manufacturing Equipment
  • Production Reactor
  • Cephalosporins APIs Plant : 80,000L
  • General APIs Plant : 205,000L
  • Production Filter & Dryer
  • Cephalosporins APIs Plant : 34,900L
  • General APIs Plant : 30,400L
TOP