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Uk Mhra Gmp
•FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A. INCORPORATED•August 10, 2015

FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A. INCORPORATED – UK MHRA GMP Certificate UK GMP 45282 Insp GMP 45282/13009579-0001[H]

Record Details

This Uk Mhra Gmp record concerns FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A. INCORPORATED, with an inspection on August 10, 2015, issued by the MHRA, covering biologics.

Company
FUJIFILM DIOSYNTH BIOTECHNOLOGIES U.S.A. INCORPORATED
Compliance status
GMPC
Certificate type
GMP
Inspection date
August 10, 2015
Issued
October 12, 2015
MIA number
UK GMP 45282
Site address
6051 GEORGE WATTS HILL DRIVE, RESEARCH TRIANGLE PARK, 27709, UNITED STATES
Country
UNITED STATES
Products
Human Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 1.3 ] Biological medicinal products [ 1.3.1 ] Biological medicinal products [ 1.3.1.5 ] Biotechnology products [ 1.3.1.6 ] Human or animal extracted products [ 1.3.1.8 ] Other biological medicinal productsManufacture of recombinant proteins for use as intermediates, critical reagents or active pharmaceut [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Kanuma, concentrate for solution for infusion
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ID · 87bd1976-c318-42fc-a0a7-36fa8bd910e7

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