Dongkoo Biopharmaceutical Wins Injunction to Suspend Execution of GMP Compliance Decision

Updated on 2024-09-10 11:45

Dongkoo Biopharmaceutical has successfully filed an injunction to suspend the execution of the Ministry of Food and Drug Safety’s decision to cancel its Good Manufacturing Practices (GMP) compliance decision.

According to the company, the court accepted the application for an injunction on September 10, allowing Dongkoo Biopharmaceutical to temporarily produce and sell solid-content drugs (hard oral medication) until 30 days from the date of the ruling in the main lawsuit for administrative disposition cancellation.

In February, the Ministry of Food and Drug Safety temporarily suspended the manufacturing and sales of two solid dosage forms manufactured and sold by Dongkoo Biopharmaceutical, including the antipyretic, analgesic, and anti-inflammatory drug ‘Loxoris Tablet’ and the antidiabetic drug ‘Glipaem Tablet 2/500mg’, and took measures to recall the products.

The Ministry of Food and Drug Safety explained that it took these measures after checking Dongkoo Bio & Pharma’s compliance with GMP and found violations of the Pharmaceutical Affairs Act, such as arbitrarily changing additives during the manufacturing process of these two products, manufacturing them differently from the permitted specifications, and falsely writing manufacturing records to indicate that they were manufactured in the same manner as the permitted specifications.

Dongkoo Biopharmaceutical has stated that it will secure sufficient inventory until the effective date to minimize the impact on the market, such as decreased sales.

Reporter: Kim Hyeon-su