Based on more the 40 years of experience in contract development and manufacturning of intermediates and APIs, AGC continues robust supply of the product with quality control in compleance with cGMP.
AGC has extensive experience in general chemical reactions, halogenation reactions including fluorination, cryogenic reactions.

Service overview

AGC offers quality-controlled stable CDMO services for pharmaceuticals and intermediates levaraging our systematic management system.
AGC has a prolific track record in halogenation, including fluorination, and ultra low temperature reactions, and respond appropriately to the diverse needs of customers globally.
For contract development and manufacturing of pharmaceuticals, we have the plants in Chiba and Wakasa, Japan and the plant in Malgrat de Mar, Barcelona, Spain and we also handle risk dispersal using the multiple bases.

Service overview_image

Features

- Fluorinated synthetic technologies -

AGC handles fluorinated synthetic technologies as follows:

  • Various types of fluorinating agents (HF, F2 gas, nucleophilic / electrophilic fluorination agents)
  • Innovative fluorination technology - PERFECT method*
    • (* The method that converts arbitrary hydrocarbon compounds into perfluoro compounds)
  • Use of plentiful fluorine-containing building blocks

- One-stop solution from development to manufacturing -

AGC is equipped with contract manufacturing capabilities able to handle various needs based on cooperation with group plants.
Wide ranging and flexible manufacturing is possible from lab schale to commercial manufacturing scale.
We are able to conduct contract manufacturing of high quality active pharmaceutical ingredients and intermediates based on efficient process development through the provision of a one stop solution from process development (non-clinical) to commercial manufacturing.

- cGMP compliance / FDA inspection experiences -

AGC offers high quality, stable production based on systematic management systems.
In response to requests, we also comply with cGMP plant manufacturing and FDA inspections.

- Global support system -

AGC has operating bases in Japan, U.S. (PA) and Spain.
We also can adequately support global contract manufacturing.

Manufacturing bases / equipment

<AGC Chiba Plant> (Ichihara City, Chiba Prefecture) *cGMP compliant

Equipment Material Volume Number
Reactors Glass Lining (GL) 1,000 ~ 15,000L 10
Hastelloy C ~ 5,000L 2
SUS 2,000 ~ 10,000L 4
Filter / Dryers Glass Lining (GL),Hastelloy C,SUS - 8
Distillation Towers SUS 2,500 ~ 5,000L 2
Micronizer Jet mill (～8㎏/ｈ),Pin mill (15~20㎏/ｈ) - 2

Environment management level: The plant has manufacturing rooms with 100,000 particles / ft3

We are equipped with chemical reactors and peripheral equipment appropriate for fluorination. We are equipped with chemical reactors and peripheral equipment appropriate for fluorination.
Filter dryer Filter dryer
Conical dryer Conical dryer
Clean bench Clean bench

<AGC Wakasa Chemicals: Obama Plant / pharmaceuticals Plant>(Obama City, Fukui Prefecture)

AGC Wakasa Chemicals
  • cGMP compliant
  • Starting materials and raw materials
Equipment Material Volume (L) Numbers Design Temp. (°C)
Reactors SUS, Glass Lining,Hastelloy C, Resin 100 to 5,000 45 -50 to 210
Distillation Towers SUS, Glass Lining up to 2,000 2 -
Centrifugal separators SUS, Resin up to 48inch 8 -
Mixed dryer SUS, Glass Lining 300 to 2,000 4 -
Filter dryer SUS 300 to 1,700 4 -
AGC Wakasa Chemicals is capable of synthesizing from 1 kg to 100 t centered on pharmaceutical / agrochemical intermediates AGC Wakasa Chemicals is capable of synthesizing from 1 kg to 100 t centered on pharmaceutical / agrochemical intermediates
AGC Wakasa Chemicals has equipment capable of manufacturing pharmaceutical ingredients. AGC Wakasa Chemicals has equipment capable of manufacturing pharmaceutical ingredients.

<AGC Wakasa Chemicals: Kaminaka Plant>(Wakasa-cho, Mikata Kaminaka-gun, Fukui Prefecture)

AGC Wakasa Chemicals
  • Intermediates and active ingredients
  • Agrochemical CDMO
Equipment Material Volume (L) Numbers Design Temp. (°C)
Reactors SUS, Glass Lining,Hastelloy C, Alloy 200 to 14,000 49 -45 to 250
Distillation Towers SUS, Glass Lining up to 8,000 7 -
Centrifugal separator SUS, Resin up to 48inch 8 -
Mixed dryer SUS, Glass Lining up to 4,000 7 -
AGC Wakasa Chemicals has equipment responsive to increased demand for agrochemical intermediates and ingredients. AGC Wakasa Chemicals has equipment responsive to increased demand for agrochemical intermediates and ingredients.

<AGC Pharma Chemicals Europe>(Malgrat de Mar, Barcelona, Spain)

AGC Pharma Chemicals Europe
  • cGMP compliant
  • Designed to handle small molecule APIs from development phase to commercial scale
  • Solid track record in Authority Inspections with no critical observations since 2007:

    • -6 times by FDA, latest 2023

    -3 times by EMA, latest 2018

    -8 times by PMDA, latest 2023

  • ISO 14001:2015 and ISO 45001:2018 Certified
AGC Pharma Chemicals Europe EHS Policy
ISO 14001 Certificate
ISO 45001 Certificate
EcoVadis Sustainability Rating: Platinum 2022
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Equipment Material Volume (L) Numbers
Reactor Glass lined, Stainless,Hastelloy up to 6,000 42
Distillation tower Glass lined, Stainless up to 6,000 5
Centrifuge Stainless, Hastelloy,Halar coated Φ 1 - 1.4m 12
Paddle dryer Stainless, Hastelloy up to 3,500 6
Tumble dryer Glass lined, Stainless,Hastelloy 2,000 5
Filter dryer Stainless, Hastelloy up to 2,500 4
Thin layer dryer Stainless 4m2 1
Micronization unit Stainless OEB4 (1 to 10 μg/m3) 1
AGC Pharma Chemicals Europe_image

Special technology

AGC is a fluorine chemical manufacturer with vast experience in fluorine chemistry and is equipped with world leading technological and production capabilities able to handle the 4 main halogens. We have a prolific track record in halogenation, including fluorination, and ultra low temperature reactions, and respond to the diverse needs of customers.

Fluorination Technology

Diazo-fluorination, Electrophilic fluorination etc.

Building blocks with “F” Components

ClCHF2, Tetrafluoroethylene derivatives, Fluorine containing gas components

Hazardous Reactions

Cyanide chemistry, Diazotization

General Organic Reactions

Grignard reaction, Lithiation, Cross-coupling, Amidation, Friedel-crafts

Oxidation/Reduction

TEMPO, NaOCl oxidation, LAH, Vitride, Silane reduction

  • Hydrogenation Reactions
  • Ultra-low Temperature Reactions （<-100℃)
  • High Potent API （OEL：1-10μg/m3）
  • Distillation（GMP）
  • Pulverization（Jet/Mechanical mill)

Environment measures

AGC has activated sludge waste water treatment equipment, HF-containing waste gas treatment equipment and organic fluorine compound incineration equipment.

cGMP

AGC offers contract manufacturing of cGMP-compliant high order intermediates and active pharmaceutical ingredients.
We are also able to handle ultra low temperature (-100°C) reactions and reactions at high pressure (0.99 MPa) under GMP, and are able to pack out products in manufacturing clean rooms with an environment management level of 100,000 particles / ft3.

Within the plant> Within the plant
QC Laboratory QC Laboratory
Ultra low temperature reaction equipment Ultra low temperature reaction equipment