The Ministry of Food and Drug Safety ordered Samsung Pharm, which had been punished for making drugs through unauthorized processes several times, to suspend all manufacturing activities for three months.
On Friday, the regulator announced that it imposed a three-month suspension on all manufacturing operations for Samsung Pharm as of Wednesday last week because the company had a production manager of its second plant handle manufacturing of the first plant.
According to the Pharmaceutical Affairs Act, a drug manufacturer must place a production manager at each manufacturing site. A violator gets a three-month manufacturing suspension as the first punishment. If the company breaches the law twice, it will face a six-month manufacturing suspension. A third violation leads to a revocation of the business license.
Samsung Pharm’s manufacturing activities will be suspended from Monday next week to Feb. 14 in 2022.
Earlier on Tuesday, Samsung Pharm had already received the regulator’s penalties, including a 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 Pharm’s law violations include the manufacturing manager’s failure to comply with the GMP organization and division of duties at the first plant, failure 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, and not complying with regulations on consigned manufacturing item (Healthnamine Inj.) and falsely making manufacturing records.
For four months, the company cannot manufacture five protein amino acid medicines – Geramin, Moarex, Combicin, Combicin 3.5g, and Combicin 4g –.
In July, the company was suspended from making and selling the five drugs and recalled them due to arbitrarily adding unauthorized additives.
At the time, the ministry’s GMP special inspection found that Samsung Pharmaceutical used additives without permission to change and created false manufacturing records.
Samsung Pharm announced the manufacturing suspension through a public disclosure on Tuesday, saying the business suspension would prevent the company from earning about 5.7 billion won ($4.8 million).
The calculation was based on the average sales of each product during the same period of last year, and the amount will be about 11.87 percent of the last year’s revenue of 48.2 billion won, the company said.
“The administrative punishment suspends manufacturing only, and our sales and distribution will continue. As we can distribute and sell products manufactured before the data of manufacturing suspension, we will secure inventory as much as possible,” Samsung Pharm said in the public filing on Tuesday.
Sales of the five drugs are expected to decrease, but the company will secure a sufficient inventory of products manufactured before the suspension and minimize damage, it added.
However, the regulator’s latest order of three-month suspension of manufacturing came after the public disclosure, and estimated financial damage incurred by the business suspension will be greater than expected.
Established in 1929, Samsung Pharm has no relation with Samsung Group, which owns Samsung Biologics. In Korea, a patent court recognized both of the names Samsung Pharm and Samsung Biologics, saying general consumers had two different perceptions of the two companies.