Bioson Pharmaceutical Ends MFDS Investigation After One Year... Final Administrative Disposition Notified

26 Violations Including Unauthorized Manufacturing Confirmed... Product Manufacturing Suspension and Other Sanctions
License Revocation, Consignment Conversion, Retesting, and Other Follow-up Actions Planned
"No Issues with Product Efficacy and Safety... Group-wide Measures to Prevent Recurrence"

[Asia Economy Reporter Lee Gwan-joo] The investigation by the Ministry of Food and Drug Safety into Vibozone Pharmaceutical, which had manufacturing-related issues, has been concluded after more than a year.

Vibozone Pharmaceutical announced on the 29th that it received the final administrative disposition notice regarding the unauthorized manufacturing of pharmaceuticals that occurred last year from the Gyeongin Regional Food and Drug Administration.

The violations subject to administrative disposition include ▲7 cases of unauthorized manufacturing ▲1 case of test method discrepancy ▲18 cases of failure to conduct stability tests, totaling 26 cases. Vibozone Pharmaceutical received a manufacturing suspension of 4 months (3 months and 15 days for Esmi tablets) for unauthorized manufacturing and test method discrepancy products, and a 1-month suspension for products without stability tests. Additionally, manufacturing suspensions were imposed by formulation: 1 month and 29 days for tablets, 1 month and 14 days for capsules, 1 month and 7 days for syrups, and 15 days for creams.

Vibozone Pharmaceutical (formerly Inist Bio Pharmaceutical) was acquired by Vibozone Healthcare in September 2020 and has been undergoing additional investigations after voluntarily reporting manufacturing-related issues prior to the acquisition to the Ministry of Food and Drug Safety in March last year.

Regarding unauthorized manufacturing items, the company confirmed issues such as changing excipients other than the main ingredient or altering manufacturing methods differently from the approved specifications. In response, they plan to withdraw approvals or convert to consignment manufacturing and re-conduct Process Validation (PV).

For products with test method discrepancies, the company explained that they had developed and applied more efficient test methods than those registered in the approval, and have now completed approval changes to the new test methods. The administrative disposition for products without stability tests was due to some missing or lost past stability test data, and the company is currently re-conducting the relevant stability tests.

A company official stated, “Since the non-compliance involved adjustments to excipients or differences in manufacturing methods, we want to reassure those concerned about the efficacy or safety of the products that there are no such issues.” He added, “Follow-up measures will be promptly implemented according to the administrative disposition, and as part of the Vibozone Group, we will focus on management at the group level to prevent recurrence of approval violations.” He further said, “Having received the final administrative disposition notice from the Ministry of Food and Drug Safety, we will thoroughly resolve pre-acquisition issues and devote ourselves to excellent pharmaceutical manufacturing and quality control.”

This content was produced with the assistance of AI translation services.