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Uk Mhra Gmp
•YICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED•October 2, 2023

YICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED – UK MHRA GMP Certificate UK GMP 48442 Insp GMP 48442/19818001-0001[H]

Record Details

This Uk Mhra Gmp record concerns YICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED, with an inspection on October 2, 2023, issued by the MHRA, covering drugs.

Company
YICHANG HUMANWELL PHARMACEUTICAL COMPANY LIMITED
Compliance status
GMPC
Certificate type
GMP
Inspection date
October 2, 2023
Issued
February 9, 2024
MIA number
UK GMP 48442
Site address
19, DALIAN ROAD, DEVELOPMENT ZONE, YICHANG, CN-443005, CHINA
Country
CHINA
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) [ 1.1.1.2 ] Lyophilisates [ 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
Scope was approval of sterile product manufacture on Lyophilized Powder for Injection (Line 1) and associated support functions to enable filling, packaging and QC testing of product for this line.
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ID · c55de7c0-abe8-405f-965f-bf3745a2c6bd

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