Change the world

J2HBiotech - Journey to Healthcare Solutions

Pharmaceutical Business Division (Ansan)

Pharmaceutical Business Division

B 349, Sandan-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Republic of Korea

Facility
  • Manufacturing
    & facility
  • QA
  • QC
  • API
    research
Pharmaceutical Business Division img01Pharmaceutical Business Division img02Pharmaceutical Business Division img03Pharmaceutical Business Division img04

APIs &
CDMO business

J2H Biotech Pharmaceutical Business Division was established in November 2020 and received GMP approval from the Korea Ministry of Food and Drug Safety in June 2022, focusing on manufacturing and quality control of high-value APIs.

We focus on developing various types of incrementally modified drug (IMD) APIs such as IMD APIs, novel crystalline salts, and pharmaceutical cocrystals for patent registration and are developing exclusive supply of APIs per client’s request.

We provide CDMO business upon customer’s needs such as high-yield & high-purity API development, patentable API development, new drug candidate synthesis, and CMC documentation.

APIs development and analysis

APIs development and analysis

  • Non-GMP and GMP facility
    Non-GMP and GMP facility
  • High potency APIs
    High potency APIs
  • Incrementally modified drug APIs
    Incrementally modified drug APIs
  • Process development
    Process development
  • Gram to kilogram-scale synthesis
    Gram to kilogram-scale synthesis
  • Patent circumvention & design of patentable APIs
    Patent circumvention &
    design of patentable APIs
  • API production for clinical use
    API production for clinical use
  • CMC Documentation
    CMC Documentation
  • Mass production for commercial use
    Mass production for commercial use

Developed APIs

Developed APIs

  • Donepezil hydrochloride monohydrate
    Donepezil hydrochloride monohydrate
  • Donepezil base
    Donepezil base
  • Bifendate
    Bifendate
  • Entresto IMD cocrystal
    Entresto IMD cocrystal
  • Orphan drugs API
    Orphan drugs API
  • CNS drugs API
    CNS drugs API