June 29, 2022

The South Korean Ministry of Food and Drug Safety ordered a three-month suspension on all manufacturing activities to Samsung Pharmaceutical. The pharmaceutical had been punished for making drugs through unauthorized processes several times.

According to reports, the regulator as of Wednesday last week has imposed the suspension on all manufacturing operations for the pharmaceutical company because it had a production manager of its second plant handle manufacturing of the first plant.

According to the South Korean Pharmaceutical Affairs Act, a drug manufacturer is required to place a production manager at each manufacturing site. And a violator of this law gets a three-month manufacturing suspension as the first punishment. In case the company breaches the law twice, it will be reprimanded with a six-month manufacturing suspension. While a third violation would lead to a revocation of the business license entirely.

The pharmaceutical company’s manufacturing activities will be suspended from Monday next week to Feb. 14 in 2022.

The company earlier on Tuesday had already received the regulator’s penalties, it included one-month suspension of manufacturing at the first factory, a four-month suspension of making five medicines including Geramin Inj., and a one-month and seven-day suspension of producing injections.

Samsung Pharmaceutical’s law violations –

• The manufacturing manager’s failure to comply with the GMP organization and division of duties at the first plant.
• It failed to comply with the item change management regulation and reporting of false manufacturing records.
• Failure to report on the change of the ingredient of the drug.
• Failure to comply with regulations on consigned manufacturing item (Healthnamine Inj.) and falsely making manufacturing records.

The company for four months under the suspension cannot manufacture five protein amino acid medicines – Moarex, Combicin, Geramin, Combicin 3.5g, and Combicin 4g.

The company announced the manufacturing suspension through a public disclosure on Tuesday, it mentioned that the business suspension would prevent them from earning about 5.7 billion won ($4.8 million).

It also mentioned that although the sales of the five drugs are expected to decrease, it will however secure a sufficient inventory of products manufactured before the suspension and minimize damage.

The regulator’s latest suspension order came after the public disclosure.