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MFDS reviews sales ban on Binex-manufactured generics

By Lee, Jeong-Hwan | translator Byun Kyung A

21.03.09 10:00:08

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Pharmaceutical companies manufactured bulk generics through Binex Busan plant could be penalized due to Pharmaceutical Affairs Act violation

4 out of 6 Binex items manufactured through consignment deal including Amorin, Xelectin and Rofsin


The impact of the allegation on Binex manipulating the manufacturing method and active ingredient dosage in six drugs including antidiabetics and antidepressants is snowballing within the pharmaceutical industry.

Source confirmed South Korea¡¯s Ministry of Food and Drug Safety (MFDS) has started reviewing administrative measure to be ordered on generics produced by Binex Busan Plant 1 as a contract manufacturing organization (CMO), which was found to have violated the Pharmaceutical Affairs Act. The ministry has already ordered manufacturing and sales ban on the six products the company decided to voluntarily recall.

On Mar. 9, MFDS official explained ¡°The ministry is reviewing the n

Lee, Jeong-Hwan(junghwanss@dailypharm.com)
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