Pfizer Korea suspends distribution of Champix

As a preemptive measure in concern over possibility of impurities

“Issue is being investigated at the global HQ level… will tentatively discontinue supply unitil results are available

Generic companies will ‘first concentrate on completing the impurity inspection tests’

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of Champix

Domestic supply of ‘Champix (varenicline),’ a smoking cessation product, has been suspended altogether.

 

Pfizer Korea, which is in charge of supplying the product, explained that this was a preemptive measure made regarding the impurity issue.

 

According to industry sources on the 23rd, Pfizer Korea had sent an official notice to domestic distributors that Champix 0.5mg and 1mg is nearly out of stock.

 

In the notice, Pfizer Korea explained that this was due to a ‘disruption in the global distribution.’ Pfizer Korea’s position is that this is a preemptive measure that was made with regards to the concerns over impurities in the product.

 

The Champix supplied in Korea is manufactured in Belgium, and is different from the products that were recalled by the health authorities in Canada earlier this month.

 

Those were a part of the products manufactures in a Pfizer plant located in Quebec, Canada.

 

The Ministry of Health and Welfare also said that the pharmaceutical products manufactured by the same company as those recalled in Canada are not being distributed in Korea.

 

However, Pfizer Korea explained that this preemptive measure was made in consideration of the potential possibility that the impurities may have arisen in the manufacturing process of the finished product, and that the company will suspend supply of the product while testing for the impurities.

 

The MFDS presumes that the impurity in question, ‘N-nitroso-varenicline’ may have developed by a reaction between varenicline and the nitrite that remained during the manufacturing process of the finished product.

 

An official from Pfizer Korea said, “An investigation is being conducted at the global headquarters level on the detection of impurities," he said.

 

"We plan to temporarily suspend domestic supply until the results of the impurities test is released." He continued, “We will submit related data to MFDS as soon as the results of the impurities investigation are released from our HQ.

 

Pfizer Korea will faithfully follow MFDS instructions.” Korean generic companies plan to first focus on testing for the impurities as requested by MFDS.

 

Because their production scale is not large, the companies believe that separate measures to stop supply will not be necessary.

 

Currently, 34 companies in Korea are approved to manufacture CHampix generics.

 

Among these, 12 companies have generated revenue in the first quarter of this year.

 

Hanmi Pharmaceutical’s ‘Nokotine S,’ recorded 500 million won in quarterly sales, and the other companies have recorded less than 100 million won in the same period.

 

An official from a domestic company that sells a Champix generic said, “We plan to first focus on conducting an independent test for impurities.

 

And we will promptly take necessary measures according to its results.” Another official from a different company said, “We currently only hold a permit for the generic.

 

We have discontinued production and supply of our generic since last year.

 

It seems that some of the products that were previously released are still being distributed., but we do not plan to halt that supply or separately recall the products.” he explained.