Uk Mhra Gmp
ASTRAZENECA PHARMACEUTICALS LP - AMYLIN OHIO LLCASTRAZENECA PHARMACEUTICALS LP - AMYLIN OHIO LLC – UK MHRA GMP Certificate UK GMP 12811 Insp GMP 12811/14959843-0002[H]
Record Details
This Uk Mhra Gmp record concerns ASTRAZENECA PHARMACEUTICALS LP - AMYLIN OHIO LLC, with an inspection on July 11, 2016, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- July 11, 2016
- Issued
- October 18, 2016
- MIA number
- UK GMP 12811
- Site address
- 8814 TRADE PORT DRIVE, WEST CHESTER, 45071, UNITED STATES
- Country
- UNITED STATES
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.6 ] Other aseptically prepared products-Exenatide Microsphere ( Powder), -Diluent( Liquid) [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 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 EU products - BYDUREON and BYETTA
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ID · 9eef7f1a-f7eb-44e5-84a7-3b1765c48b33
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