Services

Contract Manufacturing

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.

Contract Manufacturing Flow

Main Facilities

Pilot Plant

Facilities	Specification	Capacity	Quantity
Reactors Normal Pressure, -5~140℃(200℃)	Glass Lining	10L	5
	Glass Lining	300L	5
		1,000L	1
	Stainless	300L	3
		500L	1
Autoclave ~10kg/cm2, -5~140℃	Stainless	200L	1
Vacuum Distilling Apparatus 3mmHg, ～200℃	Stainless	200L	1
Centrifuge	Top emission type, Stainless	φ12 inches	1
		φ20 inches	2
		φ30 inches	1
Filter Separators	Pressurization, Stainless		2
	Reduced pressure, Stainless		2
Dryers	Shelf- fan dryer, Stainless-steel		1
	Shelf-type vacuum dryer, Stainless		1
	Conical type vacuum dryer, Stainless	30L	1
Clean Room	Clean level: 100,000/ft3 Ventilation: 20 times/hr or more		1
Freezer Medium -20℃	3600kcal/hr		1

Commercial Plant

Facilities	Specification	Capacity	Quantity
Reactors Normal Pressure～100mmHg, －5～140℃（200℃）	Glass Lining	2m3～10m3	41
	Stainless	1m3～10m3	67
	Ti clad	2.5m3	2
Autoclaves ～10kg/cm2, －5～140℃	Stainless	2m3～4m3	5
	Glass Lining	4m3	1
Photo-reactor 600〜700nm	Stainless Sodium Lamp		1
Vacuum Distilling Apparatus 3mmHg, ～180℃, N=12	Stainless	1m3～7m3	3
Centrifuges	Bottom emission type, Stainless	φ24～55 inches	5
	Top emission type, Stainless	φ24～55 inches	21
Filter separators	Pressurization, Stainless		18
	Reduced pressure, Stainless		29
	Reduced pressure, FRP		1
Dryers	Shelf-type fan dryer, Stainless		22
	Conical type vacuum dryer, Stainless	2～2.5m3	6
	Clinical type vacuum dryer, Glass Lining	2m3	2
	Nauta-type vacuum dryer, Stainless	1m3	3
		2m3	5
Mills	Pin mill, Stainless		9
	Hammer mill, Stainless		3
	Power mill, Stainless		1
	Feather mill, Stainless		1
	Jet mill, Stainless		1
Clean Rooms	Clean level: 100,000/ft3 Ventilation: More than 20 times/hr	Centrifuge rooms	10
		Drying rooms	11
		Milling rooms	12
Ice Maker	Stainless 2.4t/day		1
Wastewater treatment	Activated sludge
Freezers	Medium -20℃ Inside -10 ~ -5℃	46kW	16

Main Analytical Equipment (Shizuoka Factory)

We have necessary analytical equipment for product quality control.
We operate accordance with data integrity.
We can use the equipment of R&D in Tokyo depending on the customer’s requirements.

Equipment	Specification
HPLC	High and low pressure gradients Detector: UV, UV-VIS, RI
GC	Detector: FID Equipped with a head-space sample injection device
ICP-MS	Responding to elements subject to ICH-Q3D Step 4 Responding to organic solvents
FT-IR	7800～350cm-1
UV-visible spectrophotometers	190～900nm
Karl Fischer moisture meter	Volumetric procedure Coulometric titration
Potentiometric titrator	pH 0.00～14.00
Polarimeter	589nm (Na)
Particle size distribution analyzer	Laser diffraction type(dry and wet), microscope type, air permeability method

Main Reactions

Technologies in orange highlighted are our specialty technologies.

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.
Grignard reaction
Chlorination	NaOCl, SOCl2, PCl3, POCl3, etc.
Enantiomer synthesis	Asymmetric reduction, Optical resolution
Enzymatic reaction	Asymmetric hydrolysis, hydrolysis
Kolbe-Schmitt reaction	Carbon dioxide
Oxidation	Using H2O2, NaOCl, etc.
Diazotization	NaNO2
Cyanation	－CONH2 → －CN
Suzuki-Miyaura coupling	R-B(OH)2, Pd/C
Sulfonation	Sulfuric acid, fuming sulfuric acid, sulfur trioxide-pyridine complex
Nitration	Nitric acid, mixed acid, etc.
Nitrosation	NaNO2
Glycosidation	BF3, methanesulfonic acid
Photo-oxidation	Sodium lamp
Friedel–Crafts reaction	Acylation, Alkylating
Bromination	Br2
Formylation	HCHO, Vilsmeier reaction, etc.
Mitsunobu reaction
Phosphorylation	POCl3, PCl3
Other organic synthesis reactions

Our technology

Catalytic reduction

We have well knowledge and many experiences of actual production relating to catalytic reduction.
We will select and provide the best reduction condition based on customer’s reaction.
In addition, we have established safe and reliable handling operations from charging to recovery.
We have also realized cost reduction through recycling in collaboration with catalyst manufacturers.

Example of catalytic reduction

Photo-Oxidation		Bromination
		We have bromine tank system, so we can use bromine itself.
Friedel-Crafts Reaction		Kolbe-Schmitt Reaction
We use Aluminum Chloride. We have know-how on removing by-produced Aluminum Hydrochloride.		Reaction can be made under mild condition.
		Suzuki-Miyaura Coupling
		We can manufacture in actual equipment based on know-how regarding the use of Pd catalyst.