GMP inspection findings clarification
Correspondence from ANMAT regarding ANMAT-2020-0055. Type: information-request. Risk: medium. Category: Labeling.
Correspondence ID
COR-155
Type
information-request
Application
Authority
ANMAT
Category
Labeling
Risk
Medium
Due Date
2025-02-21
Status
Overdue
Owner
James O'Brien
Created
2022-11-24
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0055, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_155.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.