Information request: manufacturing process change justificat
Correspondence from ANMAT regarding ANMAT-2020-0055. Type: deficiency. Risk: high. Category: Labeling.
Correspondence ID
COR-555
Type
deficiency
Application
Authority
ANMAT
Category
Labeling
Risk
High
Due Date
2025-04-21
Status
Open
Owner
Nadia Petrova
Created
2022-11-23
Correspondence Body
Dear ANMAT Review Team,
With reference to application ANMAT-2020-0055, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-21 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.