MFDS Initiates Cancellation of Approval for 44 Drug Items Manufactured by Jeil Pharm

Food and Drug Safety Ministry CI (Photo by Food and Drug Safety Ministry)

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety has decided to temporarily suspend the manufacture and sale of a total of 44 pharmaceutical products manufactured, sold, or contract-manufactured by Jeil Pharmaceutical, and has initiated procedures to cancel their product approvals.

The products subject to approval cancellation by the Ministry include three items manufactured and sold by Jeil Pharmaceutical, such as the essential hypertension treatment 'Telmiduo Tab 40/5 mg,' as well as a total of 44 items including 41 products from 14 companies that Jeil Pharmaceutical contract-manufactures identically to Telmiduo Tab, such as 'Green Cross Telmiamo Tab' (Green Cross) and 'Novasc T Tab' (LG Chem).

This action follows the findings of the 'Pharmaceutical Manufacturing and Quality Control Standards (GMP) Special Inspection Team,' which conducted an inspection of Jeil Pharmaceutical from the 27th of last month to the 8th of this month and confirmed that the residual solvent test data submitted for the approval of Telmiduo Tab were falsified. When a company obtains product approval through fraudulent or dishonest means, the product approval cancellation process proceeds in accordance with the Pharmaceutical Affairs Act.

The Ministry of Food and Drug Safety has distributed a safety alert to medical professionals, pharmacists, and consumers, requesting cooperation to switch the 44 products subject to cancellation to alternative medicines and to ensure proper product recalls. The Ministry of Health and Welfare and the Health Insurance Review and Assessment Service have been asked to prevent prescriptions of these products at hospitals and clinics.

A representative of Jeil Pharmaceutical stated, "We will identify the cause as soon as possible and take measures to minimize confusion and damage at the prescription sites."