[Alpha Biz= Reporter Kim Minyoung] Sinsin Pharmaceutical made an announcement on the 15th that the manufacturing of its flagship products has been suspended for about three months due to violations of the Pharmaceutical Affairs Act, including false preparation of manufacturing records and failure to comply with standards.
The manufacturing suspension period of SinsinPas-Arex is three months and 15 days (April 25, 2024 to August 8, 2024), and the manufacturing suspension period of the Inta Synthesis (Indometacin) is three months (April 25, 2024 to July 24, 2024).
The head of the Daejeon Regional Food and Drug Safety Office said that Sinsin Pharmaceutical manufactured two items, Sinsin Pasarex and Inta Synthesis, and falsely wrote or failed to fill out the actual date and time of the manufacturing process in its manufacturing records. It also explained the reason for the disposal that some processes were carried out and the process variables were not recorded in the manufacturing records. According to the process inspection regulations, the process inspector should conduct a process inspection on the process inspection method of the product standard, but the application amount test (once per 120m) was not recorded in the process inspection record.
Sales of the two drugs, whose manufacturing operations were suspended this time, stood at 20.3 billion won last year. It is 19.81% of last year's sales of 102.6 billion won.
Alphabiz Kim Minyoung (kimmy@alphabiz.co.kr)
