Protox, a biopharmaceutical company, announced on the 3rd that it has obtained clinical plan approval and GMP approval for Protoxin, a botulinum toxin drug, from the Ministry of Food and Drug Safety, as of the 31st of last month.

Protoxin State, developed as an ATCC3502 strain, conducts clinical trials with finished products that have verified quality control results that meet “standard and test methods,” such as non-clinical safety and efficacy data that meet international standards, and reverse prices of undiluted and finished products.

A Protox official said, “We have made efforts to develop products with safety and reliability by completing monkey toxicity tests as well as rodents early, and we have transparently identified the source and source of strains used when applying for clinical trial approval by the Ministry of Food and Drug Safety.”

Protox is rapidly developing as it received approval for clinical trials eight months after completing the construction of a GMP-standard factory last year and obtaining a manufacturing license.

Meanwhile, the botulinum toxin preparation plant located in the Hyangnam Pharmaceutical Complex has increased safety and efficiency by establishing the entire production process as an automated system, and is capable of producing 2.7 million vials of protoxin liquor annually.

Reporter Choo Min-sun cms@newsprime.co.kr