(Health Korea News / Lee Chang-yong) CTC Bio received approval from the Gyeonggi Food and Drug Safety Administration for the medicines it manufactures, ‘Laprazole Tablet 10mg (Rabeprazole Sodium)’ and ‘Duresin Orally Dissolvable Film 0.2mg (desmopressin acetate). ‘, ‘Arotin tablets 10mg (atorvastatin calcium trihydrate)’, It was announced through a public notice on the 14th that a one-month manufacturing suspension was imposed for four items, including ‘Arotine Tablets 20mg (Atorvastatin Calcium Trihydrate)’. The manufacturing suspension period for these four items is from November 18 to December 17, 2024.
In the case of suspension of manufacturing of the relevant dosage form (tablet), an order was given for 7 days (November 18 to November 24, 2024). The expected production restart date for tablet formulation manufacturing business is November 25.
The operating profit (sales) of these four items last year was approximately 30.82343 billion won, which is equivalent to 22.3% of the total sales (137.87804 billion won). Although it was a one-month manufacturing suspension (1/12th of annual sales), it was an administrative sanction for a considerable amount of money.
However, the company drew a line, saying, “The impact of this measure on reducing sales performance will be minimal.”
A CTC Bio official told Health Korea News on the 15th, “We humbly accept the results of this administrative disposition,” adding, “The administrative disposition to suspend manufacturing operations was limited to some of the company’s products, and as only the manufacturing of those items is suspended during the disposition period, business will be halted.” “There are no restrictions on sales activities.” This is interpreted to mean that there is little impact on the decrease in sales performance due to the manufacturing halt because there are already produced inventory.
This official promised, “We clearly promise to prevent recurrence in the future by complying with relevant laws and regulations,” and “We will do our best to supply excellent medicines.”
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Source: www.hkn24.com
