Celltrion and Jeil Health Science, which entrusted ICURE with the production of patch-type drugs, received a three-month administrative suspension of manufacturing operations due to ICURE's GMP violations.
According to the Ministry of Food and Drug Safety, Celltrion and Jeil Health Science, an affiliate of Jeil Pharmaceutical, were placed on the list of the ministry’s administrative discipline on Monday.
Celltrion received a three-month manufacturing suspension for Donerion Patch 87.5 mg (donepezil) and Donerion Patch 175 mg. Jeil Health Science also got a three-month manufacturing suspension for Jeil Top Cataplasma (flurbiprofen) and Jeil Long Pap Plasta (loxoprofen sodium hydrate).
Accordingly, Celltrion and Jeil Health Sciences will not be able to produce these items subject to the administrative penalty from July 3 to Oct. 2.
The administrative penalties against Celltrion and Jeil Health Science resulted from good manufacturing practice violations by ICURE, the contract manufacturer of these products. According to the ministry, ICURE was found to have failed to comply with the standard in manufacturing them.
Therefore, the ministry held Celltrion and Jeil Health Science responsible for not thoroughly managing and supervising their trustee, ICURE, based on Article 31, Paragraph 1 of the Pharmaceutical Affairs Act and Article 76, Paragraph 1 of the same act. Both companies are likely to suffer sales setbacks due to this administrative discipline.
Donerion Patch is a patch-type dementia treatment based on donepezil jointly developed by ICURE and Celltrion through global clinical trials. Celltrion holds domestic rights and launched it in the Korean market last August with the application of insurance benefits.
Jeil Health Science, which has shown strength in plasters by focusing on the so-called “penguin patch,” such as Kepentech, entrusted the production of its patch products to ICURE as the company began remodeling and expanding its Yongin factory in 2019. Jeil Health Sciences also received a three-month manufacturing suspension for Jeil Top Cataplasma and Jeil Long Pap Plasta due to ICURE's GMP violations in November 2021.
Jeil Health Sciences launched a new topical anti-inflammatory and analgesic patch, Loxfentec Plasta, based on loxoprofen.