Otsuka Korea’s schizophrenia drug hit with 1-month manufacturing suspension

Otsuka Pharmaceutical Korea's Abilify 2mg (ingredient: aripiprazole), a schizophrenia drug, has been subject to an administrative penalty due to the company's failure in 2021 to comply with the regulations regarding the provision of small packaging units of medicines.

The Ministry of Food and Drug Safety ordered a one-month manufacturing suspension order on Otsuka Korea's schizophrenia drug, Abilify 2mg.

The Ministry of Food and Drug Safety (MFDS) said Friday that it suspended manufacturing of the drug for one month from May 12 to June 11.

According to IQVIA, a drug market research firm, Otsuka Korea’s Abilify lineup is the top-selling schizophrenia drug in Korea.

In 2020, the total market size for aripiprazole drugs in Korea was about 58 billion won ($43.5 million), and Otsuka’s three products, including Abilify tablet, Abilify OD tablets, and Abilify Maintena injection, accounted for 50.9 billion won in sales.

Otsuka Korea was unavailable for immediate comments.