Contract Manufacturing of APIs

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  3. Contract Manufacturing of APIs
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The production system follows
GMP/Global Quality Standards.
Supply high-quality APIs stably and continuously.

Kyowa Pharma Chemical manufactures APIs, compounds in the early stages of development, and APIs for clinical studies by using our unique chiral technologies such as enzyme reaction, asymmetric synthesis, and optical resolution methods.
In order to ensure a stable and continuous supply of high-quality APIs, we devote our total manufacturing technologies (including the design and engineering of production facilities) to establish each plant. The production systems at multi-purpose plants rationalize and optimize the process of each product, and allow us to handle large-volume batch production to low-volume production and multi-items production. Our production facilities that are rich in variety can handle a wide range of production scales. We establish flexible production systems with these facilities, and these have been well-received by a lot of our customers.
Furthermore, we have established a management system in accordance with GMP (Good Manufacturing Practice) and global quality standards.
We can respond to a wide range of customer requirements in terms of quality and pharmaceutical regulatory affairs.

Contents of Contract Manufacturing

We offer total support from early R&D to the commercial stage.



Production of related substances and samples

We support research such as synthesis study of samples (FTE basis).

Clinical Study


Manufacturing of APIs to support clinical studies

We manufacture APIs for clinical studies using gram-scale manufacturing equipment.



Process development

We have extensive experience in the process of developing complex
and highly potent small molecules (e.g., Prostaglandins).

Contract Manufacturing of APIs

We have systems conforming to US, EU, and Japan GMP requirements.

Maturity stage
(Product Lifecycle)

Process improvement and optimization

We have achievements in process improvement using Bioconversion methods.

Development Support and Patents List

We have several patents. Our flexible technology enables support from the early stages of development.

■Patents List

Synthesis methods
for Prostaglandins
JP 2019-131510, International Publication WO 2020/195437, pending 1
International Publication WO 2021/132536
Manufacturing methods
for optically active substances
(Catalyst derived from plants)
Patent No. 6678442, No. 6630667
International Publication WO 2021/200487, and 4 applications are in process
Patent No. 4533415, No. 4680775, and many others

Click here to see our recent research results

■Introduction to Unique Patents

In addition to patents related to the synthesis process, we also have our own unique patents.

Asymmetric ring-opening reaction of meso-epoxides catalyzed
by water-soluble polysaccharides from soybean


  1. Developed a functional catalyst derived from a plant
  2. The function is present in many plants
  3. Components of ordinary foods can also be catalysts
  4. Main structural component is the “carbohydrate chain”
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Property of the Catalyst

Heat resistance : Remains active at 100° C
Recycle : Possible (Regeneration treatment is NOT needed)
Physical property : Non-soluble in organic solution (Easily separable by filtration after the reaction)

Substrate specificity

Facilities and Equipment

We have a production system with comprehensive manufacturing technology, high efficiency, and environmental protection at the same time. In order to provide a stable and continuous supply of high-quality products that meet our customers' requirements, we establish plants with total manufacturing technology, including engineering technology.

Introduction to Our Facilities

Plant A
APIs and Intermediates
Lot size up to 50 kg
Major facilities Manufacturing area Reactor 10L, 20L, 50L [Glass flask]
100L, 200L, 500L, 600L, 800Lx2, 1600L, 2000L [GL]
50L, 100Lx2, 200L, 500Lx2, 1200Lx2, 1500Lx2 [SUS]
Silica gel column 30L, 40L, 150L, 250L, 350L, 500L [SUS]
Flash evaporator 10L x 2, 50L x 2 [Glass]
Rotary evaporator 10L, 20L x 4 [Glass]
Centrifuge 30B [SUS], 30B [Hastelloy], 36B [Hastelloy]
Conical dryer 400L[GL]
Controlled room Two rooms
Rotary evaporator 1L x 3, 10L x 2
Flash evaporator 50L x 2 [Glass]
Lyophilizer 40L/ batch
Plant B
APIs and Intermediates
Lot size up to 30 kg(300-500L)
Major facilities Manufacturing area Reactor 340L (-80~120℃) [GL] , 500L (-30~120℃) [GL],
340L (-30~120℃) [GL] , 300L (-30~120℃) [SUS]
Portable mixing tank 100L x 3  [SUS]
Portable tank 200L x 2  [SUS], 200 L[Hastelloy]
Filter 0.3m2 [SUS] x 2, 0.5m2 [SUS]
Vacuum shelf dryer 3m2 [SUS]
Milling machine Possess
Controlled room Two rooms
Reactor 300L (-25~120℃) x 2 [SUS]
Filter dryer 0.3m2 [SUS], 0.3m2 [Hastelloy]
Plant C
Lot size up to 800 kg(3,000-10,000L)
Major facilities Manufacturing area Reactor 3000L, 9200L, 10000L [GL]  etc.
3000L, 6000L, 10000L [SUS]  etc.
Reduction reactor 4900L [GL] , 5000L [SUS]
Filter dryer 1700L [SUS]
Centrifuge 48B [Hastelloy] , 48B[SUS]
Conical dryer 4000L [GL]
Plant D
APIs and Intermediates
Lot size up to 30kg(10-800L)
Major facilities Manufacturing area Reactor 10L, 20L [GLASS]
200L, 200L, 800L [SUS]
500L, 800L [GL]
Filter 20L, 70L, 120L [SUS]
Conical dryer 450L [SUS]
Portable column Possess
Flash evaporator 50L
Rotary evaporator 20L x 2
Controlled room Crystallization tank
20L, 50L
Filter dryer 20L x 2[SUS]
Flexible isolator Possess
Plant E
APIs and Intermediates
Lot size up to 800 kg(3,000-8,000L)
Major facilities Manufacturing area General Work Area Zone1 General Work Area Zone2
Reactor 8000L×2 [GL]
8000L [SUS]
Reactor 8000Lx2 [GL]
6000L [SUS]
Dissolution tank 3000L, 5000L [GL]
3000L [SUS]
Dissolution tank 5000L x2 [GL]
Agitation tank 6000L×2 [GL] Agitation tank 6000L [GL]
Centrifuge 48B [Hastelloy] Centrifuge 48B [Hastelloy]
Conical dryer 4000L×2 [GL] Conical dryer 4000L [GL]
Purified water
manufacturing facility
Possess Purified water
manufacturing facility
Controlled room Reactor 8000L [GL]
Centrifuge Φ1000 [Hastelloy]
Conical dryer 4000L [GL]

Quality Assurance / Quality Control