[Photo provided by Daewoong Pharmaceutical Co.]
South Korea’s Daewoong Pharmaceutical Co. said on Thursday it is on course to export its botulinum toxin Nabota to Canada upon receiving the Good Manufacturing Practices (GMP) certification from the Canadian health authorities for its manufacturing plant dedicated to the product.
GMP describes minimum standard for manufacturing and quality management of pharmaceutical products.
The latest certification comes after Daewoong Pharmaceutical received a “compliant” grade from Health Canada earlier this month after a five-day inspection on the manufacturing facility of Nabota, a biological medicine better known as botox that is a widely used treatment for wrinkles. The Canadian federal health department informed Daewoong Pharmaceutical in October,last year that it was accepting its new drug application filed in July of that year.
Nabota is currently under new drug application review by the Canadian health authorities.
The GMP for manufacturing facility sets the company on track to receive marketing approval possibly within the year, a company official said.
Daewoong Pharmaceutical has also recently received approval for its Nabota plant from U.S. Food and Drug Administration (FDA) but was asked to supplement documents for new drug approval for the second Nabota manufacturing facility in Hwaseong, Gyeonggi Province, completed in October last year to supply products to North America.
Daewoong Pharmaceutical is currently complementing final documents for approval of its new drug submission as requested by U.S. FDA and expects final clearance in the first quarter of next year at the latest, the company official said.
Shares of Daewoong Pharmaceutical ended at 207,000 won ($191.9) on Thursday, down 0.48 percent from the previous session.
By Shin Chan-ok and Lee Eun-joo
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