Health Canada recalls [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-06-09 11:16 (225 d 22:11 ago) – Posting: # 24026
Views: 4,113

Dear all,

on 7 June Health Canada recalled Accel-Ondansetron ODT, Mint-Betahistine and PMS-Pirfenidone tablets due to data integrity concerns.

Health Canada’s authorization of the affected products relied on the bioequivalence test data. Bioequivalence data is used to demonstrate that generic drugs are equivalent to their brand-name counterparts.
The bioequivalence tests were conducted by Synapse Labs Pvt. Ltd., a contract research organization in Pune, Maharashtra, India. An inspection by a member of the European Medicines Agency, a trusted regulatory partner, found that data produced by Sy­na­p­se Labs can no longer be relied upon to show this bioequivalence. As a result, the affected products can no longer be considered safe and effective. At Health Canada's request, the companies have stopped sale and have recalled all lots of the affected products until they can provide additional information to demonstrate that the products are safe and effective.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,363 posts in 4,906 threads, 1,679 registered users;
96 visitors (0 registered, 96 guests [including 10 identified bots]).
Forum time: 08:28 CET (Europe/Vienna)

The combination of some data and an aching desire
for an answer does not ensure that a reasonable answer
can be extracted from a given body of data.    John W. Tukey

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5