The Ministry of Food and Drug Safety (MFDS) has imposed administrative penalties for pharmaceutical companies that violated GMP (good manufacturing practice) rules.
According to the ministry, CMIC CMO Korea received a 15-day administrative penalty on Dec. 5 to suspend the manufacturing of its ointment formulations. The suspension period is from Dec. 20 to Jan. 3. The company’s Exchiel Plus Ointment is an over-the-counter drug used to treat hemorrhoids and is distributed by Kolon Pharma.
CMIC CMO Korea was found to have failed to comply with the company's standard “DATA Integrity Regulation” when manufacturing Exchiel Plus Ointment. The company also failed to comply with its standard “Manufacturing Instruction and Record Book Operation Regulation” when manufacturing consignment items.
Hanmi Pharmaceutical, which consigned CMIC CMO Korea to manufacture Titibe Ointment 0.25% (prednicarbate), also received an administrative penalty for negligence in the management and supervision of the consigned producer. The punishment is a three-month suspension of Titibe Ointment from Dec. 20 to March 19 next year.
Titibe Ointment is an external steroid preparation, a specialized drug used to treat corticoid-responsive skin diseases, including eczema and dermatitis (including atopic dermatitis, seborrheic dermatitis, contact allergic dermatitis, pseudo psoriasis, lichen planus, pruritic rash) and psoriasis.
Mirae Pharm received administrative penalties for eight over-the-counter products. The company did not conduct finished product release tests when manufacturing and selling these items. It did not comply with the company's standard “GMP Personnel Organization and Work Division Regulations” when manufacturing DK Tab, Emona Cap, and Seletamin Tab.
On Dec. 6, the MFDS issued a three-month manufacturing suspension order for the company’s Hitamin Tab, Multive Q Gold Tab, Cyverine Tab, and Clofen Tab. The suspension period is from Dec. 25 to March 24.
Mirae Pharm also received one-month and 15-day manufacturing suspension orders for the same items on Oct. 26. MFDS explained that the suspension followed the previous suspension.
In addition, the ministry imposed a three-month and 15-day (from Dec. 20 to April 3) manufacturing suspension on the company’s DK Tab. Emona Cap and Seletamin Tab while imposing a 4.5 million won ($3,450) fine on Barocal-F Cap' instead of a three-month manufacturing suspension.
Cires Pharmaceutical was found to have failed to comply with the company's standard “Management of manufacturing instructions and records” and “GMP organization and work division” when manufacturing entrusted items. It was suspended from manufacturing its tablets for one month (Dec. 18, 2023, to Jan. 17) and its creams for 15 days (Dec. 18 to Jan. 1, 2024).
Korea Arlico Pharm received a slew of administrative penalties for intentional GMP violations. On Dec. 8, the MFDS announced administrative penalties against Korea Arlico Pharm for violating fiduciary compliance (false manufacturing instructions and manufacturing records) and production management obligations for pharmaceuticals (false manufacturing instructions and manufacturing records).
As a result, in addition to a one-month and 15-day suspension of the manufacture of Thioct HR Tab (thioctic acid) (Dec. 22-Feb. 5) and a three-month suspension of the manufacture of Pitastin Tab 4 mg (pitavastatin calcium) (Dec. 22-March 21), the company has received a 15-day suspension of the manufacture of tablet formulations.
Accordingly, Korea Arlico Pharm will be unable to manufacture tablet products from Dec. 22 to Jan. 5, 2024. Following the suspension, the company issued a public notice regarding it. According to the disclosure, the suspension was worth 120.1 billion won, 71.61 percent of the company’s sales of 167.7 billion won in the previous year.
This administrative penalty suspends manufacturing activities for the period, and sales and distribution activities are maintained. For products manufactured and shipped before the date of suspension, the company will respond by securing inventory as much as possible because distribution and sales are possible, Korea Arlico Pharm said in the public notice.
“As we have secured sufficient inventory of products according to our sales plan in advance in anticipation of the administrative penalty, we expect the impact to be minimal, such as a decrease in sales," the company went on to say. "We will do our best to prevent recurrence in the future by complying with relevant laws and regulations."