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Investigation of Varenicline has been undertaken

By Chon, Seung-Hyun | translator Choi HeeYoung

21.06.14 11:20:14

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Instructions for testing Nitrosamines for impurities



Health authorities have launched an investigation into Nitrosamines impurities in non-smoking drugs "Champix" and generics for Champix.

According to industries on the 14th, the MFDS recently ordered pharmaceutical companies to follow up on Varenicline's impurities (Nitrosamines).

The MFDS said, "Recently, there is a possibility of Nitrosamines impurities among Varenicline." The MFDS requested, "To take preventive measures, we will review the manufacturing process and follow-up measures such as testing impurities in Nitrosamines."

Varenicline is a major active ingredient in Pfizer's anti-smoking drug Champix. 34 domestic pharmaceutical companies have generics for Varenicline

Chon, Seung-Hyun(1000@dailypharm.com)
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