ApprovalTrail

Approval · Notice of Compliance 36824 · 2026

ONE-ALPHA: Notice of Compliance 36824

Issued February 2, 2026

A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.

Notice number
36824
Date
February 2, 2026
Company
Cheplapharm Arzneimittel GmbhGreifswald, Mecklenburg - West Pomerania, Germany
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Addition of a drug product manufacturing site and/or manufacturer involving production. Addition of a drug product manufacturing site and/or manufacturer involving primary packaging. Change in the batch size for the drug product.

Products in this notice

BrandDINStatus today
ONE-ALPHANot yet assigned—

Medicinal ingredients