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Uk Mhra Gmp
•FDC LIMITED•June 17, 2024

FDC LIMITED – UK MHRA GMP Certificate UK GMP 18807 Insp GMP 18807/7201-0014[H]

Record Details

This Uk Mhra Gmp record concerns FDC LIMITED, with an inspection on June 17, 2024, issued by the MHRA, covering drugs.

Company
FDC LIMITED
Compliance status
GMPC
Certificate type
GMP
Inspection date
June 17, 2024
Issued
February 14, 2025
MIA number
UK GMP 18807
Site address
B-8, MIDC INDUSTRIAL ESTATE, WALUJ, AURANGABAD, IN-431136, INDIA
Country
INDIA
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) [ 1.1.1.4 ] Small volume liquids [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.3 ] Moist heat [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
Restrictions
Lines ALP-I and ALP-II have been inspected for the manufacture of BFS spike bottles. Lines ALP-III and ALP-IV have been inspected for the manufacture of BFS insert bottles.
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ID · 16b136c8-3fd1-4e5f-a644-be75c69e671a

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