Facilities

General APIs Plant 1

General APIs Plant 1 manufactures PMDA-approved, high purity and quality general active pharmaceutical ingredients (APIs) for exportation to Japan. Through continuous API registration as Europe’s CEP and to the US FDA, we, as the greatest corporation in APIs, are continuing to strive towards becoming a global corporation. In addition, we’ve completed remodeling the pilot facility and are continuing to prepare to expand our capacity for CMO.

General APIs Plant 3

General APIs Plant 3 was completed in 2015 to increase our capacity to manufacture general active pharmaceutical ingredients. The plant consists of cGMP-compliant production lines capable of accommodating production scales ranging from 1kg units to as much as 300kg units to facilitate custom orders. As a company specializing in the manufacture of active pharmaceutical ingredients, KB Pharmaceutical operates various production lines that includes a pilot facility to form the foundation for CMO. Furthermore, we recently installed a PTS (Powder Transfer System), an ingredient input machine, into our operations to do our very best at manufacturing high-potency, high-quality active pharmaceutical ingredients with worker safety as our utmost priority.

General APIs Plant 2

General APIs Plant 2, where we manufacture nonsterile cephalosporin APIs and crude sterile APIs, recently underwent comprehensive remodeling in 2015. The facility is cGMP-approved by Japan’s PMDA, Europe’s EDQM, and the US FDA. The facility also passed a regular EDQM inspection in 2015 and a regular FDA inspection in 2016, proving itself once again as a world- class nonsterile cephalosporin drug manufacturing facility with an advanced and effective QA system.

Solid Oral Dosage Form Plant

KB Pharmaceutical operates a solid oral dosage form production facility that has been specialized for the manufacture of cephalosporin drugs and is making great progress in the domestic CMO market. KB Pharmaceutical is also capable of using internally produced API to manufacture finished drugs and of producing reliable, high-quality products. Our solid oral dosage form line that manufactures cephalosporin drugs in pill and capsule formats utilizes automated sorting machines to prevent distribution of defective drugs.

Synthetic APIs Plant 4

General Plant 4, a cytotoxic anticancer drug substance production facility with high technology, completed in 2014, is capable of blocking all external exposure of cancer drugs with the help of isolator facilities, powder transfer systems (PTS), and drum closed systems (DCS). Following the certification from the MFDS (Korean Food & Drug Administration) in 2014, the facility was also certified through SafeBridge Consulting in the US as the appropriate closed facility.

Synthetic APIs Plant 5

Sterile APIs Plant 1

KB Pharmaceutical’s plant for manufacturing sterile active pharmaceutical ingredients is certified by Japan’s PMDA and South Korea’s MDFS. Access to the sterile facility is controlled strictly; sterile active ingredients are filled inside glove boxes to prevent contamination by the workers; and a fumigation system using hydrogen peroxide and a real-time particle monitoring system are used to prevent exogenous contamination to manufacture trustworthy, high-quality, and safe sterile active pharmaceutical ingredients.

Sterile APIs Plant 2

KB Pharmaceutical’s plant for manufacturing sterile cephalosporin drugs is cGMP-certified by Japan’s PMDA, Europe’s EDQM, and the US FDA. The facility also passed a scheduled EDQM inspection in 2015 and a scheduled FDA inspection in 2016, proving itself once again as a world- class sterile active pharmaceutical ingredient manufacturing facility with an advanced and effective QA system.

Sterile Medical Vials Plant

Our workshop for manufacturing cephalosporin powder vials by directly injecting sterile cephalosporin drugs produced in-house utilizes automated filling machines by Bosch that minimize the margin of error in the amount of the drug filled and enable precise calibrations to produce high-quality injectable powders.