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Uk Mhra Gmp
•CATALENT CTS (EDINBURGH) LIMITED•February 7, 2022

CATALENT CTS (EDINBURGH) LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 25274 Insp GMP/GDP/IMP 25274/29333-0019[I]

Record Details

This Uk Mhra Gmp record concerns CATALENT CTS (EDINBURGH) LIMITED, with an inspection on February 7, 2022, issued by the MHRA, covering drugs.

Company
CATALENT CTS (EDINBURGH) LIMITED
Compliance status
GMPC
Certificate type
GMP/GDP
Inspection date
February 7, 2022
Issued
April 26, 2022
MIA number
UK MIA(IMP) 25274
Site address
UNIT 1 INCHWOOD PARK, BATHGATE, EH48 2FY, UNITED KINGDOM
Country
UNITED KINGDOM
Products
Human Investigational Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Investigational Medicinal Products [ 1.1.3 ] Batch certification [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.2 ] Batch certification [ 1.3 ] Biological investigational medicinal products [ 1.3.2 ] Batch certification [ 1.3.2.1 ] Blood products [ 1.3.2.2 ] Immunological products [ 1.3.2.3 ] Cell therapy products [ 1.3.2.4 ] Gene therapy products [ 1.3.2.5 ] Biotechnology products [ 1.3.2.6 ] Human or animal extracted products [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.2 ] Capsules, soft shell [ 1.5.1.3 ] Chewing gums [ 1.5.1.4 ] Impregnated matrices [ 1.5.1.8 ] Other solid dosage forms [ 1.5.1.11 ] Semi-solids [ 1.5.1.12 ] Suppositories [ 1.5.1.13 ] Tablets [ 1.5.1.14 ] Transdermal patches [ 1.5.1.17 ] Other non-sterile medicinal productsCytostatics, cytotoxics, hormone products may undergo primary packaging, pessaries [ 1.5.2 ] Secondary packaging 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.2 ] Batch certification of imported medicinal products [ 2.2.1 ] Sterile Products [ 2.2.1.1 ] Aseptically prepared [ 2.2.1.2 ] Terminally sterilised [ 2.2.2 ] Non-sterile products [ 2.2.3 ] Biological medicinal products [ 2.2.3.1 ] Blood products [ 2.2.3.2 ] Immunological products [ 2.2.3.3 ] Cell therapy products [ 2.2.3.4 ] Gene therapy products [ 2.2.3.5 ] Biotechnology products [ 2.2.3.6 ] Human or animal extracted products [ 2.3 ] Other Importation Activities [ 2.3.1 ] Site of Physical Importation [ 2.3.2 ] Importation of Intermediate which undergoes further processing [ 2.3.4 ] OtherImportation of QP-certified IMPs from a country on the approved country for import list
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ID · de5775c2-a177-4668-90b6-488e8980fc43

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