Quality Approved
Samsung Biologics announced on September 7 that the company received the additional approvals of production of six items from the FDA and the EMA which are a US and a European drug quality and safety certification organization.
Samsung Biologics received seven approvals (recent two from the FDA, recent four from the EMA and one from the FDA in 2015) in a relatively short period, which proves the company’s global quality competitiveness.
The approvals will allow Samsung Biologics to sell its products to the US and European markets which account for over 80% of the global bio pharmaceutical market. In particular, most drug firms usually proceed with the procedure for the approval of one product at one organization. But with the goal of slashing time for approvals, Samsung Biologics applied for the approval of multiple products at multiple organizations and succeeded.
Samsung Biologics expects to become the number one company in the global CMO sector with a production capacity of 360,000L in 2018 the third plant will be completed.