The Ministry of Food and Drug Safety ordered Hana Pharm to temporarily suspend its narcotics products such as anesthetics and pain relievers.
Expecting the administrative punishment will take a significant toll on its sales, the company said it would take legal actions against the MFDS. In a public filing on Tuesday, Hana Pharm said it received the MFDS’ order to suspend narcotics business for a month from Oct. 8 to Nov. 7.
Hana Pharm faced the administrative penalty because the MFDS judged that the company violated Article 14 and Enforcement Rule 25 of the Narcotics Control Act.
The Narcotics Control Act’s Article 14 states that manufacturers, importers, and exporters of narcotics may advertise narcotics or psychotropic drugs only through media or means targeting medical, pharmaceutical, and veterinary professionals. This also applies to product briefing sessions, and the product's description should include information on precautions for use, such as adverse reactions.
The business suspension is expected to cause 14.7 billion won ($12.2 million) worth of financial damage, or 8.33 percent of Hana Pharm’s annual revenue of 177.3 billion won in 2020.
However, the company said it would not accept the MFDS’ decision.
“We plan to apply for a court’s suspension of the MFDS’ execution and file an administrative suit to nullify the administrative punishment,” Hana Pharm said in the regulatory filing.
Hana Pharm has already requested the Seoul Administrative Court to stop the MFDS from executing the administrative order. However, as the Seoul Administrative Court decided to accept Hana Pharm’s request on Friday, it will suspend the effect of the administrative punishment until Oct. 27, the company said.
After Hana Pharm’s filing, the Korea Exchange ordered a temporary suspension of trading Hana Pharm’s stock from the market closing time on Tuesday to 9 a.m. Wednesday. This was to stop after-hours trading before the market opening on Wednesday.
Hana Pharm’s narcotics include Fentanyl Citrate Inj. (fentanyl citrate), Remiva Inj. (remifentanil hydrochloride), Hana Alfentanil Inj. (alfentanil hydrochloride), Ocodone (oxycodone hydrochloride), and Morphine Sulfate Tab. (morphine sulfate hydrate).
In January, Hana Pharm obtained the MFDS’ marketing approval for Byfavo Inj. (remimazolam), a new anesthetic drug. The company introduced the treatment after signing an exclusive deal with Germany’s biotech firm Paion in 2013. Hana Pharm released Byfavo in Korea in March, and the drug is indicated for induction and maintenance of general anesthesia.