Pharmaceutical CMO service and development of API and intermediates <General Name > organic synthesis

Service overview

AGC Chemicals offers everything from the development of original pharmaceutical ingredients to quality-controlled stable production of pharmaceuticals and intermediates on a contract basis using our systematic management system.
AGC Chemicals 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 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.

Features

- Fluorinated synthetic technologies -

AGC Chemicals 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 including everything from development to manufacturing -

AGC Chemicals 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 small scale (mg size) to manufacturing scale (ton 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 process from development (non-clinical) to commercial manufacturing.

- cGMP compliance / FDA inspection experiences -

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

Manufacturing bases / equipment

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

MaterialVolumeDesign Temp. (°C)Number
ReactorsGlass Lining1,000 ~ 6,000L-30 ~ 180°C2
Hastelloy C100 ~ 1,000L-100 ~ 180°C2
SUS1,000 ~ 3,000L-100 ~ 400°C7
Fluororesin Lining200L-1
Multi-tubular reactorInconel-
Distillation TowersSUS230 ~ 2,400L--
Centrifugal separator variousφ42B--
Pressure filtersSUS500 ~ 1,500φ--
Dryersvarious1,000 ~ 1,200L-
Filter dryerSUS2,000L--
Refrigeratorsvarious--
Thin film evaporator SUS--

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.

Filter dryer

Conical dryer

Clean bench

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

cGMP compliant
Starting materials and raw materials
EquipmentMaterialVolume (L)NumbersDesign Temp. (°C)
ReactorsSUS, Glass Lining,

Hastelloy C, Resin
100 to 5,00045-50 to 210
Distillation TowersSUS, Glass Liningup to 2,0002-
Centrifugal separatorsSUS, Resinup to 48inch8-
Mixed dryerSUS, Glass Lining300 to 2,0004-
Filter dryerSUS300 to 1,7004-

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

Intermediates and active ingredients
Agrochemical CDMO
EquipmentMaterialVolume (L)NumbersDesign Temp. (°C)
ReactorsSUS, Glass Lining,

Hastelloy C, Alloy
200 to 14,00049-45 to 250
Distillation TowersSUS, Glass Liningup to 8,0007-
Centrifugal separator SUS, Resinup to 48inch8-
Mixed dryerSUS, Glass Liningup to 4,0007-

AGC Wakasa Chemicals has equipment responsive to increased demand for agrochemical intermediates and ingredients.

< AGC Seimi Chemical > (Chigasaki City, Kanagawa Prefecture)

MaterialVolumeDesign Temp. (°C)Number
ReactorsGlass Lining100 ~ 3,000L-12
SUS100 ~ 1,000L-50 ~ 180°C7
Hastelloy C200 ~ 500L-80 ~ 200°C4
Fluororesin Lining1,500L-30 ~ 60°C1
Distillation TowersVarious300 ~ 1,000L
Centrifugal separatorsVariousΦ20 ~ 36inch
Pressure filtersFluororesin Lining~ 900φ
ColumnsSUS~ 300φ
DryersVarious500 ~ 800L

AGC Seimi Chemical carries out contract synthesis of functional chemicals and pharmaceutical intermediates.

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

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 2018
- 3 times by EMA, latest 2018
- 9 times by PMDA, latest 2017
ISO 14001:2015 and ISO 45001:2018 Certified
- AGC Pharma Chemicals Europe EHS Policy (PDF)
- ISO 14001 Certificate (PDF)
- ISO 45001 Certificate (PDF)
EcoVadis Sustainability Rating: Platinum 2022 (PDF)
EquipmentMaterialVolume (L)Numbers
ReactorGlass lined, Stainless,

Hastelloy
up to 6,00048
Distillation towerGlass lined, Stainlessup to 4,0004
CentrifugeStainless, Hastelloy,

Halar coated
Φ 1 - 1.4m13
Paddle dryerStainless, Hastelloyup to 3,5006
Tumble dryerGlass lined, Stainless,

Hastelloy
2,0005
Filter dryerStainless, Hastelloyup to 2,5005
Thin layer dryerStainless4m21
Micronization unitStainlessOEB4 (1 to 10 μg/m3)1

Special technology

AGC Chemicals 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.

■ Halogenation

Halogen exchange reactions
Nucleophilic fluorination
Electrophilic fluorination
Diazo fluorination
“PERFECT” process
Electrolysis fluorination
Apart from the above, reactions using anhydrous fluoride (HF), fluorine gas (F2),tetrafluoroethylene (TFE), chlorotrifluoroethylene, (CTFE) and iodine pentafluoride (IF5), etc., are also possible.

■ Ultra low temperature reactions

Down to a minimum temperature of -100°C

■ Use of fluorine-containing building blocks

Heterocyclic compounds
Fluoroalkyl group introduction

■ Various types of organic synthesis

Friedel-Crafts
Grignard
Various types of cross coupling
Oxidation
Reduction (hydrogenation)
High pressure reactions (toxic / combustible high pressure gas)
High temperature reactions

Photoreactions (e.g.: using UV, etc.)
Polypetides / oligomerization
Polymer reactions
Optically active compounds (enantioselective synthesis)
Terminal functional group protection
Distillation (atmospheric distillation, pressurized distillation, vacuum distillation, extraction distillation, water steam distillation)
Granulation
Pulverization
High purity refining
Use of ion-exchange resins / ion-exchange membranes
High vacuum
Use of membrane technology
Gas phase thermal decomposition reaction

Environment measures

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

cGMP

AGC Chemicals 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

QC Laboratory

Ultra low temperature reaction equipment

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PRODUCT LIST

Inquiries

Sales contactTELFAXADDRESSWEB
JapanAGC Inc.+81-3-3218-5462+81-3-3218-7854Shin-Marunouchi Bidg., 1-5-1
Marunouchi Chiyoda-ku, Tokyo, Japan
http://www.agc.co.jp/
EUAGC Chemicals Europe, Ltd.
(Agro & Speciality)
+31-20-880-4170+31-20-880-4188Zuidplein 80
1077 VX Amsterdam, The Netherlands
http://www.agcce.com/
AGC Pharma Chemicals Europe, S.L.U.
(Pharma)
+34-93-766-97-00Camí de la Pomereda, 13
08380 Malgrat de Mar (Barcelona), Spain
https://www.agcpharmachemicals.com/
USAAGC Chemicals Americas, Inc.+1-610-423-8119+1-610-423-430155 East Uwchlan Ave, Suite 201
Exton, PA 19341
http://www.agcchem.com/