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Uk Mhra Gmp
•TEVA NI LIMITED•April 29, 2024

TEVA NI LIMITED – UK MHRA GMP Certificate UK MIA(IMP) 10947 Insp IMP 10947/1802-0019[I]

Record Details

This Uk Mhra Gmp record concerns TEVA NI LIMITED, with an inspection on April 29, 2024, issued by the MHRA, covering drugs.

Company
TEVA NI LIMITED
Compliance status
GMPC
Certificate type
IMP
Inspection date
April 29, 2024
Issued
July 11, 2024
MIA number
UK MIA(IMP) 10947
Site address
OLD BELFAST ROAD, MILLBROOK, LARNE, BT40 2SH, UNITED KINGDOM
Country
UNITED KINGDOM
Products
Human Investigational Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 1.2 ] Non-sterile investigational medicinal products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.1 ] Capsules, hard shell [ 1.2.1.2 ] Capsules, soft shell [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.11 ] Semi-solids [ 1.2.1.13 ] Tablets [ 1.2.1.17 ] Other non-sterile medicinal productsHormonal Products [ 1.2.2 ] Batch certification [ 1.5 ] Packaging [ 1.5.1 ] Primary packaging [ 1.5.1.1 ] Capsules, hard shell [ 1.5.1.2 ] Capsules, soft shell [ 1.5.1.8 ] Other solid dosage forms [ 1.5.1.11 ] Semi-solids [ 1.5.1.13 ] Tablets [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.3 ] Chemical/Physical 2. IMPORTATION OF MEDICINAL PRODUCTS [ 2.3 ] Other Importation Activities [ 2.3.4 ] OtherImportation of QP certified IMPs from a country on the approved country for import list
Restrictions
Secondary packaging on site limited to open label activities only. No complex blinded packaging activity performed. The GMP certificate includes authorisation to carry out QC and stability testing of commercial products.
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ID · 1d281f8c-f625-4385-9847-7e3f6ded0d49

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