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Pharmaceutical GMP-compliant Facilities

 

Compliance with Pharmaceutical GMP

[Photo]Compliance with Pharmaceutical GMP

Based on precise synthesis technology for organic chemicals acquired through synthesis of photographic organic chemicals, we can offer contract manufacturing of APIs/ intermediates.
By taking advantage of our accumulated fine chemical synthesis technologies, we have conducted many researches to deal with recent pharmaceutical syntheses, which have become increasingly complex, and have achieved satisfactory results. With such experience and achievement, we will serve customers to meet any of their requests for organic synthesis.

GMP-compliant facilities

Facilities name Scale Site
Facility for APIs/intermediates P3 4,000 (GL) Hirono Factory
Facility for APIs/intermediates for investigational drugs K1/D1 600L (GL)
D2 1,500L (GL)

Special Devices

Counter jet mill, power mill, sieving machine

1,000L Hastelloy ultra low-temperature reactor (-90ºC)

1,200L SUS low-pressure reduction reactor (0.5 MPa)

Produced Items

  1. Active pharmaceutical ingredients/intermediates
  2. Active pharmaceuticals/intermediates for investigational drug

Inspection History

[Photo]Inspection History

  • Pharmaceuticals and Medical Devices Agency(PMDA)
    GMP compliance review for partial change of approval items(August 2006)
  • Sousou Public Health and Welfare Office,Pharmaceutical Affairs Division, Fukushima Prefecture
    GMP compliance review by Prefectural Pharmaceutical Affairs Group of Health & Hygiene Area(June 2007)
  • Domestic users, overseas users

Pharmaceuticals-related Businesses

[Photo]Pharmaceuticals-related Businesses

Related Information

Operating company that leads the Fujifilm Group's imaging and information solutions.

Drug discovery company that leads Fujifilm Group's pharmaceutical products field.


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