Research Business Area

CDMO / mRNA / Peptide / PEG / Generic drugs / IMD / Cephalosporin dugs

CDMO mRNA Peptide PEG Generic drugs IMD Cephalosporin drugs
Excellent Research Skills
We have developed our own technology for synthesizing Cephalosporin antibiotics with complicated properties and delicate stability
Capable of performing API synthesis with high purity / high stability / compatible physical properties, etc.

Development of a cefotaxime synthesis method for the first time in Korea, reverse export of technology to Ceftriaxone’s original company (Roche) for the first time in Korea, self-developed patents, etc.

Global Technology
Manufacture of excellent quality Cephalosporin antibiotics that satisfy international standards

In the process of exporting to Europe, Japan, and China, the U.S. FDA approval history of injectable API for the first time in Korea, recently passed the conformity assessment in China for the first time as a foreign company

30 Years of Accumulated Research
/ Production Expertise
CDMO and CMO are capable of handling various cephalosporin antibiotics.
High-purity API development
Rapid response to client requests
Continuous cost reduction and productivity improvement
Continuous quality improvement
Strict impurity management
Hanmi Fine Chemical is a company with excellent experience and technology in raw material medicine, and has decades of research and development experience and synthetic quality management capabilities.

Selection of Products

Process &
Quality Differentiation Study

Pilot test &
Impurity Study

PAR Study & Scale up
&Analytical Validation

Process Validation
& CTD

Development Status of Generic drugs

Antidiabetic
0 Case
Anti
hypertensive
0 case
Hyperuricemia
0 case
Antiulcer
0 case
Anti
Hyperlipidemia
0 case
Anti
Histamine
0 case
Antiviral
0 case
Anti
Depressant
0 case
Anti
Coagulant
0 case
Anti Asthma
0 case
Incrementally Modified Drugs (IMD)
Drugs that have improved the disadvantages of the original drugs using technology to change salts, crystals, formulations, etc.
Effects of IMD Development
The effect of market preoccupation by enabling faster market entry by avoiding the original patent.
Safety of IMD
Safety for the human body is secured as they are developed using FDA-approved salts.

IMD Development Status

New Salt
0 Case
Polymorphism
0 case
Co - crystal
0 case

Provide GMP-based, high-quality peptides with independently-developed resin
and professional synthesis technology.

01
Development of Peptide Synthesis Technology
Possession of strategic synthesis methods according to peptide sequence./ Manufacturing of high-quality peptides through purification specialists.
02
Professional Analytic Skills
Possession of multiples of the latest analysis equipment. Possession of technology for the separation and quantification of impurities at high levels of difficulty. Development of a synthesis strategy that minimizes impurities through impurity profiling.
03
Various Equipment for Lab Scales
Possession of various scale reactors including automated synthesizers.
04
GMP Facility
Possession of a GMP facility with a thorough management system for quality assurance.
05
Resin Development
Development of an independent resin for high-purity peptide synthesis (patent application).

Abundant PEG Derivative Technology
GMP Facility Establishment

Manufacturing of PEG derivatives in accordance with the GMP regulations, provide high-quality PEG derivatives

01
Independent PEG Derivative
Manufacturing Technology
Manufacturing of high-quality PEG products at GMP facilities based on Hanmi Fine Chemical's technology (various PEG derivatives of PEGylated Peptides, PEG Lipids of mRNA, etc.)
02
Derivatives of
Polyethylene Glycol (PEG)
High molecular materials used in various biopharmaceuticals, mRNA vaccines, and therapeutics, as well as ADC drugs (PEG 3.4K, PEG 10K, etc.)
03
Heterobifunctional
PEG Synthesis
Capable of manufacturing high value-added Heterobifunctional PEG products that meet our customers’ needs.

Manufacture of modified nucleoside and mRNA 5'-cap Analog,
as well as the development and manufacture of key raw materials for purified LNP.

NTP Base-modified NTPs
(5-Methyl-CTP,N1-Methylpseudo-UTP)
/Sugar-modified NTPs

mRNA 5'-cap Research and development and
manufacturing of 5'-cap Analog

LNP Cationic Lipid / PEG-Lipid

Purification of Oligonucleotides

mRNA Purification System

Small molecule (NCE, AG), PEG & Peptide
process development,
GMP Manufacturing and Preparation of Approval Documentation

Raw Material Sourcing
Research & Development
GMP Manufacturing
CTD & CMC
01
One-stop service from raw material sourcing to CTD & CMC preparation
02
Fully customized services, including process development
improvement and analytical method development & validation
03
Highest level GMP manufacturing system based on thorough quality control and authorization
04
Manufacturing facilities set up for various pipelines, such as small molecules, peptides, and PEGs
05
CTD & CMC preparation fully customized for the designated authorities
06
Continuously expanding CDMO capabilities from formulation development to commercial manufacturing