TOPTOP > English > Custom Manufacturing Services > APIs, Pharmaceutical Intermediates, Fine Chemical Products

APIs, Pharmaceutical Intermediates, Fine Chemical ProductsFeatures of custom manufacturing services of APIs, pharmaceutical intermediates, and fine chemical products of IWAKI SEIYAKU CO., LTD.

We respond to requests for any type of outsourcing production,
from process development to GMP bulk production.

Based on our synthesis technology accumulated over a long period, we respond to requests for any type of outsourcing smoothly,
from development stage to production.

Thanks to completion of a new plant for small-scale GMP production, we have the production capacity to respond flexibly to various kinds of needs, from small-scale to large lot production, along with existing large automated facilities for GMP, and high-performance multi-purpose facilities.

Under high quality control system that conforms to c-GMP and ICH standards and based on DMF, CEP registration, and experience with FDA inspections, we provide outsourcing services that will satisfy our customers.

In addition, we proactively engage in EHS (Environment, Health, Safety) investment.

Custom Manufacturing Services

List of custom manufacturing services

List of custom manufacturing services

Main reactions and specialty reactions

Specialty reactions

  • Reduction
  • Optical resolution
  • Oxidation
  • Glycosidation
  • Bromination
  • Phosphorylation
  • Friedel–Crafts reaction
  • Kolbe-Schmitt reaction
  • Suzuki-Miyaura reaction

[Main reactions]

Acylation Acid chloride, acid anhydride, etc.
Amidation Ammonia, amines, etc.
Amination By reduction of nitro and nitroso, and by using amines
Alkylation Dialkyl sulfuric acid, alkyl halide, etc.
Esterification Various organic and inorganic acids, and alcohol
Reduction By catalytic hydrogenation, using NaBH4, sulfurous acid, etc.
Chlorination NaClO, SOCl2, PCl3, POCl3, etc.
Optical resolution Resolving agent, enzyme-mediated asymmetric hydrolysis
Oxidation 1) Photo-oxidation (using sodium lamp), 2) Using H2O2,NaClO, PbO2, etc.
Diazotization NaNO2
Cyanation -CONH2 → -CN
Sulfonation Sulfuric acid, fuming sulfuric acid, sulfur trioxide-pyridine complex
Nitration Nitric acid, mixed acid, etc.
Nitrosation NaNO2
Glycosidation BF3, methanesulfonic acid
Bromination Br2
Formylation HCHO, Vilsmeier reaction, etc.
Phosphorylation POCl3, PCl3,etc.
Friedel–Crafts reaction Aluminum-chloride
Kolbe-Schmitt reaction Carbon dioxide
Grignard reaction RMgBr
Mitsunobu reaction DIAD
Suzuki-Miyaura reaction R-B(OH)2, Pd/C
Other organic synthesis reactions  
Enzymatic reaction Asymmetric hydrolysis, hydrolysis
Extraction of natural products  
Inorganic synthesis  

Specialty technology

Catalytic reduction

Catalytic reduction

Friedel-Crafts reaction

Friedel-Crafts reaction

Photoreaction (Oxidation)

Photoreaction (Oxidation)

Glycosidation

Glycosidation

Bromination reaction

Bromination reaction

Phosphorylation reaction

Phosphorylation reaction

Kolbe-Schmitt reaction

Kolbe-Schmitt reaction

Pyrazolone derivatives

Pyrazolone derivatives

Grignard reaction

Grignard reaction

Reduction

Reduction

Mitsunobu reaction

Mitsunobu reaction

Suzuki-Miyaura coupling

Suzuki-Miyaura coupling

Introduction to our facilities

Main facilities

Facilities Specifications Capacity Quantity
Reactors
Normal pressure to 100 mmHg
-5°C to 140°C (200°C)
Glass lining 2,000L 4
3,000L 7
4,000L 9
5,000L 3
7,000L 10
10,000L 4
Stainless-steel 1,000L 3
2,000L 9
3,000L 17
4,000L 13
5,000L 11
6,000L 3
7,000L 12
10,000L 3
Ti clad steel 2,500L 2
Autoclaves
Up to 1 MPa
-5°C to 140°C
Stainless-steel 1,500L 1
2,000L 1
4,000L 3
Glass lining 4,000L 1
Photo-reactors
600 to 700 nm
Stainless steel sodium lamp   1
Vacuum distilling apparatus
2 mmHg, up to 180°C
N = 12
Stainless-steel 1,000L 1
3,200L 1
7,000L 1
Centrifuges Bottom emission type, stainless-steel φ24 to 55 inches 7
Top emission type, stainless-steel φ24 to 55 inches 21
Filter separators Pressurization, stainless-steel   21
Reduced pressure, stainless-steel   29
Reduced pressure, FRP   2
Dryers Shelf-type fan dryer, stainless-steel   28
Conical type vacuum dryer, stainless-steel 2,000 to 2,500 L 6
Clinical type vacuum dryer, glass lining 2,000L 2
Nauta-type vacuum dryer, stainless-steel 1,000L 3
Nauta-type vacuum dryer, stainless-steel 2,000L 5
Mills Pin mill, stainless-steel   9
Hammer mill, stainless-steel   4
Power mill, stainless-steel   2
Jet mill   1
Clean rooms Clean level: 100,000/ft3
Ventilation: More than 20 times/hr
Centrifuge rooms 10 rooms
Drying rooms 10 rooms
Milling rooms 10 rooms
Ice maker Stainless-steel
10 t/day
  1
Wastewater treatment Activated sludge    
Freezers Medium: -20°C
Inside: -5°C to -10°C
46kW 14

Pilot plant facilities

Facilities Specifications Capacity Quantity
Reactors
Normal pressure
-5°C to 140°C (200°C)
Glasses 10L 5
Glass lining 300L 5
Stainless-steel 300L 3
500L 1
1,000L 1
Autoclaves
Up to 1 MPa
-5°C to 140°C
Stainless-steel 200L 1
Vacuum distilling apparatus
3 mmHg
Up to 200°C
Stainless-steel 200L 1
Centrifuges Top emission type, stainless-steel φ12inches 1
φ20inches 2
φ30inches 1
Filter separators Pressurization, stainless-steel   2
Reduced pressure, stainless-steel   2
Dryers Shelf-type fan dryer, stainless-steel   1
Shelf-type vacuum dryer, stainless-steel   1
Conical type vacuum dryer, stainless-steel 30L 1
Clean rooms Clean level: 100,000/ft3
Ventilation: 20 times/hr or more
  1room
Freezer 3,600 kcal/hr
Medium: -20°C
  1

Major analytical equipment

Equipment Specifications
HPLC High and low pressure gradients
Detector: UV, UV-VIS, RI, fluorometric, and PDA
Preparative HPLC
GPC Low pressure gradients
Detector: RI, PDA
GC Detector: FID
Equipped with a head-space sample injection device
NMR 300MHz
Responding to polynuclear species measurement
(1H、13C、15N、17O、19F、29Si、31P etc.)
LC/MS/MS Triple quadrupole type
APCI interface
LC/MS Single quadrupole type
DUIS interface
ICPーMS Responding to elements subject to ICH-Q3D Step 4
Responding to organic solvents
FT-IR 7800~350cm-1
UV-visible spectrophotometers 190 to 900 nm
Differential thermal-thermogravimetry measuring device Room temperature to 1,100°C
Karl Fischer moisture meter Volumetric procedure
Coulometric titration
Potentiometric titrator pH 0.00 to 14.00
-2,000 to 2,000 mV
Polarimeter 589nm(Na)
Particle-size distribution analyzer Laser diffraction type, microscope type, air permeability method
X-ray diffractometer X-ray source: Cu, 600W
Atomic absorption analyzer Furnace method (185 to 900 mm)

Flow of Custom Manufacturing Services

The person responsible for experimentation will handle test manufacturing, commercial scale production test, and subsequent correction consistently.

In this way, we avoid time loss, communication error, etc., due to handover.

Flow of Custom Manufacturing Services