The government ordered Withus Pharmaceutical to suspend manufacturing of Retonase Tab. (streptokinase/streptodornase) for three months, pointing to the company’s failure to run a quantitative test on the product.
|Withus Pharmaceutical’s Retonase|
The Ministry of Food and Drug Safety on Thursday notified the administrative punishment on Withus Pharm on the ministry’s homepage.
According to the ministry, Withus Pharm did not thoroughly operate the quantitative test on streptodornase, one of the ingredients of Retonase.
A quantitative test is to measure a drug’s composition, content, and content units by a physical, chemical, or biological method. The test is significant to confirm whether the drug has enough ingredients and the result of the test directly affects the efficacy of the medicine.
The ministry suspended Withus Pharm from manufacturing Retonase for three months from Dec. 24 to next March 23.
Retonase is used for relieving inflammatory swelling after surgery or trauma, relieving inflammatory edema of sinusitis and thrombophlebitis, and addressing expectoration difficulty associated with respiratory diseases.
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