Samsung Pharmaceutical to suspend manufacturing and sales of 6 manufactured items

[의학신문·일간보사=정민준 기자]Random manufacturing, which had been quiet, exploded again The size of the market for Samsung pharmaceutical-related items is about 3.85 billion won as of 2019.

On the 8th, the Ministry of Food and Drug Safety (Director Kang-Rip Kim) temporarily stopped manufacturing and sales of 6 items (5 in-house, 1 consignment) including ‘Geraminju’ manufactured by Samsung Pharmaceutical, a pharmaceutical manufacturer, and took measures to recall it.

This measure is based on the results of a special inspection of Samsung Pharmaceutical by the ‘Pharmaceutical GMP Special Planning and Inspection Group’ △ Random use of additives without obtaining change permission (report) △ False preparation of manufacturing records, etc. pharmacist law Following the identification of violations.

The detailed items are △in-house manufactured Samsung Pharm Geraminju, Molexinju, Combishinju, Combishinju 3g, Combishinju 4.5g △consigned manufacturing Apogen Pharm Healthnaminju.

For each item, the production performance in 2019 was 35.897 million won for Geraminju, 276.81 million won for Moorex, 439.91 million won for Combicinju, 2,285.93 million won for 3grams, and 1,9758 million won for Combishinju. The total amount is about 3.85 billion won, including 10,000 won and 33.63 million won for Health Na Minju.

The Ministry of Food and Drug Safety will convert the six items into alternative medicines and ensure that product recalls can be performed properly.Safety breaking news that requests the cooperation of experts such as pharmacistsIt was distributed to pharmacists and consumer groups and requested the Ministry of Health and Welfare and Health Insurance Review and Assessment Service to take measures not to prescribe the item in hospitals and clinics.

An official from the Ministry of Food and Drug Safety said, “We will continue to operate a ‘Special GMP Inspection Team for Pharmaceuticals’ and conduct unscheduled inspections of pharmaceutical manufacturing plants throughout the year, considering patient safety as the top priority and promptly taking necessary measures.”


Leave a Reply

Your email address will not be published. Required fields are marked *