Promise of Quality

Production Equipment

Through cooperation between our Research Department and Manufacturing Department, we are able to support multi-step production for orders ranging from several kilograms to several tons. With our multi-purpose equipment, we manufacture a wide range of high-quality APIs and intermediates through cGMP-compliant production and quality control.

Equipment at the Hirakata Plant

With the cooperation of the Research Department, we support sample work, pilot production, and high-mix, small-volume production to medium-scale production of commercial products.

Equipement		Material	Size	Unit
Reactor		GL	1,400～2,000 L	10
			600～1,000 L	4
			50～300 L	5
		SUS	500 L～1,200 L	12
			80 L	1
Autoclave reactor		SUS	600 L (0.97 MPa)	1
High-temperature reaction reactor		SUS	700 L (～200℃)	1
Drying equipment	Air tray dryer	SUS	300～500 Ｌ	7
	Vacuum tray dryer	SUS	200 L	1
	Conical dryer	GL	300～800 L	3
Centrifuge	Top discharge type	SUS	24 inch	10
		Aflon lining	24 inch	3
		Hastelloy and ETFE	15 inch	1
Filtration equipment		GL	50～100 L	2
		SUS	50～110 L	4
		SUS	Columns	2
Pulverizing equipment	Soft mill	SUS	―	2
	COMIL	SUS	―	1
Clean room (Class 100,000)
Centrifuge	Top discharge type	SUS	24 inch	1
Drying equipment	Tray dryer	SUS	500 L	1

You can scroll horizontally to see it.

Equipment at the Toyama Plant

We support large-volume production of pharmaceutical intermediates and active pharmaceutical ingredients including after midterm investigating and commercial products.

Equipement		Material	Size	Unit
Reactor		GL	8,000 L	1
			2,000～5,000 L	25
			500～800 L	3
		SUS	1,500～5,000 L	15
			350 L～1,000 L	4
Autoclave reactor		GL	3,000 L (0.97 MPa)	2
			800 L (0.97 MPa)	1
Drying equipment	Air tray dryer	SUS	1,000 L	3
	Conical dryer	GL	1,500～2,000 L	4
		SUS	1,500 L	1
Centrifuge	Top discharge type	SUS	30～42 inch	11
		Aflon	30 inch	3
	Bottom discharge type	SUS	24～36 inch	8
	Horizontal type	Hastelloy	Φ1,300mm	1
Filtration equipment		GL	0.13～0.5 m²	6
		SUS	0.13～0.50 m²	11
Pulverizing equipment	Soft mill	SUS	―	2
	COMIL	SUS	―	2
	Fine impact mill	SUS	―	1
	Pin mill	SUS	―	1
	Line Impact Mill	SUS	―	1
Clean room (CLASS 100,000)
Reactor		GL	4,000 L	1
Centrifuge	Top discharge type	SUS	30 inch	2
Drying equipment	Conical dryer	GL	800 L、1,500 L	2
Other
Pulverizing equipment, Sieving equipment, Centrifugal thin film vacuum evaporater, Ultrafiltration unit, Electrolyzer system

You can scroll horizontally to see it.

The 3rd building Equipment

We constructed a new building to improve production capacity in 2016. It complies with the current GMP and computer controlled systems are installed.

Equipement		Material	Size	Unit
Reactor		GL	10,000 L	1
			8,000 L	1
			5,000～6,000 L	5
			3,000 L	1
		SUS	800、2,000 L	2
Autoclave reactor		GL	3,000 L (0.97 MPa)	2
Drying equipment	Conical dryer	GL	1,500 L、2,000 L	2
Centrifuge	Top discharge type	SUS	42 inch	1
		HASTELLOY	42 inch	1
	Bottom discharge type	SUS	48 inch	1
Filtration equipment		GL	0.12 m²	1
		SUS	0.5 m²	1

You can scroll horizontally to see it.

Analytical equipment

Physical Methods	Chromatography High-performance liquid chromatograph (HPLC) Charged Aerosol Detector (CAD) Gas chromatograph(GC) Headspace sampling system Spectroscopic Methods Nuclear magnetic resonance spectrometer (FT-NMR) Atomic absorption spectrophotometer Inductively coupled plasma atomic emission spectrometry Ultraviolet and visible spectrophotometers (UV/VIS) Infrared spectrophotometer (FT-IR) Other Physical Methods Refractometer Karl Fischer moisture titrator Polarimeter Potentiometric titrator Conductivity meter Differential thermal analysis and thermogravimetry equipment (DTA, TG) Powder X-ray diffractometer Total organic carbon analyzer (TOC) Melting point apparatus	Powder property Determinations	Tap density determinator Polarizing microscope, optical microscope, Stereoscopic microscope Laser diffraction particle size analyzer
		Microbial Tests	Toxinometer Microbial testing apparatus (Clean bench, safety cabinet, autoclave, dry heat sterilizer, incubator)
		Other	Stability testing chamber

Research System

Our Research Department located in the Hirakata Plant plays a central role in our contract development and manufacturing operations. The department applies our extensive knowledge of organic synthesis and scale-up technologies to meet client needs at all stages of APIs and intermediates manufacturing.

The Research Department is fully equipped with various devices and equipment needed to test industrialization and manufacturing methods. Our system meets client delivery schedules and product quality specifications and is capable of addressing any issues that arise.

Main experimental devices and equipment

NMR、LC-MS、HPLC、UPLC、GC、SC-DSC、TG-DTA、XRPD、Easy Max 402 HFcal(Reaction calorimeter)、Particle Track(Real-time particle distribution measuring device)、Easy Viewer(Particle image analyzer)

GMP Compliance System

Our GMP system, constructed for strict compliance with domestic and overseas GMP and ICH GMP guidelines for APIs, has received approval from the PMDA in Japan, the FDA in the U.S., and regulatory authorities in Europe, and is rated highly by clients as well.
We have also created and engage a Pharmaceutical Quality System to improve the quality of pharmaceutical products and ensure stable supply. The Quality Assurance Department and Quality Control Department engage in all quality-related requirements independently of the Manufacturing Division, and are fully authorized to execute GMP management.
Manufacturing management follows a strict GMP system in all processes from raw material procurement to product shipment.
Our comprehensive system enables us to fully meet the quality standards of our clients.

GMP organization chart

We have constructed the following proprietary GMP organization at our Hirakata Plant and Toyama Plant.

Documentation system of GMP

From arrival of raw materials to shipment of product

Audits and Inspections

Manufacturing APIs and intermediates requires inspections by regulatory authorities or audits by clients. Both of our plants have been evaluated highly in inspections by regulatory authorities and in audits by clients.