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Contract Manufacturing

Pharmaceutical Business

Outline

UBE offers total solution of APIs & intermediates manufacture.


  • UBE supports your projects from development stage to commercial phase.
  • UBE's experienced process chemists and engineers establish the optimal manufacturing process.
  • UBE also develops and validates test methods upon request.
  • UBE manufactures your clinical APIs & intermediates under contract to support your drug development.
  • UBE prepares and submits filing documents (e.g. drug master files (DMFs)) upon request.
  • UBE provides a stable supply of your compounds after launch utilizing reactors of considerable capacity.
  • UBE's manufacturing is controlled based on the current good manufacturing practices (cGMP). UBE had pre-approval inspections (PAI) by the US Food and Drug Administration (FDA). Our latest PAI was in April 2008.

FDA Inspections Track Record

UBE had pre-approval inspections (PAI) by US-FDA, and the customer's products were approved.

US-FDA
2002 Advanced Intermediate (PAI)
2008 API (PAI)

UBE also has a variety of inspections and audits by regulatory authorities in Japan as well as a lot of pharmaceutical customers in the US, Europe, and Japan.

DMFs Filing Record

UBE prepares and submits filing documents (e.g. drug master files (DMFs)) upon request.

US-FDA Europe Japan
(Manufacturing Approval)
1998 API for human drug (IND) 1998~ API for animal drug (NDA) 1993 API for human drug
1998 Intermediate for human drug (NDA)   1995 API for human drug
1999 Intermediate for animal drug (NDA) 2000 API for human drug
2000 API for human drug (IND) 2003 API for human drug
2004 API for human drug (IND)  

Manufacturing Facilities

Manufacturing Facilities

Factory and process R&D are located in the same single site of Ube city, Yamaguchi prefecture, Japan. Technical transfer from pilot to commercial is done in the same single site.
The APIs produced in UBE are all new original drugs for the original pharmaceutical companies in the US, Europe, and Japan.

No.1 API Plant (cGMP/ API)

Equipment Size/ Capability Material
Reactor 4,000L (2 units) Glass lined
3,000L Glass lined
2,000L Glass lined
2,000L SUS316
1,300L Glass lined
Separator, Dryer Centrifuge 36inch (2 units) Teflon® lined*1
Centrifuge 36inch (2 units) SUS316L
Conical dryer 1,500L Glass lined
Conical dryer 1,500L SUS316
Distillation column Sulzer 4,000H (2 units) SUS316
No.1 API Plant (cGMP/ API)

No.2 API Plant Train-1 (cGMP/ API)

Equipment Size/ Capability Material
Reactor 4,000L (3 units) Glass lined
Separator, Dryer Centrifuge 42inch (2 units) Teflon® lined*1
Filter 1m2 (2 units) SUS316
Filter 0.8m2 Glass lined
Conical dryer 3,000L (2 units) Glass lined
Tray dryer 16m2 SUS316
Pulverizer Jet mill 40kg/h SUS316
Comil®*3 100kg/h Hastelloy® C-22*2

No.2 API Plant Train-2 (cGMP/ Intermediates)

Equipment Size/ Capability Material
Reactor 4,000L Glass lined
8,000L (4 units) Glass lined
8,000L (2 units) SUS316
Separator, Dryer Centrifuge 48inch SUS316
Centrifuge 48inch Teflon® lined*1
Filter 3m2 SUS316
Filter 4m2 SUS316
Filter 2m2 Hastelloy® C-22*2
Conical dryer 2,000L SUS316
Conical dryer 3,000L SUS316
Conical dryer 3,000L Glass lined

No.3 API Plant (cGMP/ Intermediates)

Equipment Size/ Capability Material
Reactor 8,000L (2 units) Glass lined
10,000L SUS316
15,000L (3 units) Glass lined
Separator, Dryer Centrifuge 48inch Teflon® lined*1
Centrifuge 48inch SUS316
Filter 4m2 Hastelloy® C-22*2
Filter 4m2 SUS316
Filter 5m2 SUS316
Conical dryer 6,000L Glass lined
Conical dryer 6,000L SUS316

Pilot Plant (cGMP/ API & Intermediates)

Total of 3 lines (Train-A, B, C)

Equipment Size/ Capability Material
Reactor 2,000L (5 units) Glass lined
2,000L Stainless steel
1,000L Glass lined
500L (2 units) Glass lined
200L Glass lined
50L Glass lined
High pressure ( ~ 0.7 MPa) 2,600L Stainless steel
Max blend type 2,000L Glass lined
Low temperature (-90 ~ 90 °C) 500L Stainless steel
Separator, Dryer Centrifuge 42inch Teflon® lined*1
Centrifuge 42inch Stainless steel
Centrifuge 30inch Stainless steel
Filter 0.3m2 (2 units) Glass lined
Filter 0.2m2 Hastelloy® C-22*2
Filter 0.2m2 Glass lined
Filter dryer 0.2m2 Hastelloy® C-22*2
Tray dryer 9.2m2 Stainless steel
Vibrating dryer 240 L Titanium lined
Conical dryer 1,000L Glass lined
Conical dryer 1,000L Stainless steel
Pulverizer Jet mill 10kg/h Stainless steel
Hammer mill 10-30kg/h Stainless steel
Comil®*3 40kg/h Stainless steel
*1
Teflon® is a registered trademark of Du Pont in Japan and other countries.
*2
Hastelloy® is a registered trademark of Haynes International, Inc. in Japan and other countries.
*3
Comil® is a registered trademark of Quadro Engineering Corporation in Japan and other countries.

Contracting Manufacturing Process for Pharmaceuticals

Contracting Manufacturing Process for Pharmaceuticals

Inquiry

Products Inquiry
  • Ube Industries, Ltd.
  • Pharmaceutical Div.,
  • Pharmaceutical Marketing & Development Dept.
  • Phone : +81(3)5419-6178
  • Fax : +81(3)5419-6257
  • Products Inquiry Form