SEOUL, South Korea and JAKARTA, Indonesia, May 27, 2020 /PRNewswire/ — Daewoong Pharmaceutical (CEO Sengho Jeon) announced on May 25 that the Indonesian joint venture Daewoong Infion (CEO Chang Woo Suh) obtained Halal certification for the diabetic foot ulcer drug ‘Easyef topical solution(Easyef)’ from the Indonesian Halal certification agency LPPOM MUI on May 20.
Easyef is Korea’s first biologic drug approved by the Korean Ministry of Food and Drug Safety (MFDS) in 2001 for the treatment of diabetic foot ulcer. Daewoong Pharmaceutical has conducted continuous research to upgrade the dosage form of Easyef through Daewoong Infion. In March this year, the integrated dosage form produced originally from Daewoong Infion obtained marketing authorization from the Indonesian National Agency of Drug and Food Control (BPOM) and successfully obtained Halal certification in just 2 months.
Indonesia, which has the largest Muslim population in the world, implemented the Halal Product Law, which mandated companies to indicate whether they have Halal certification for food, cosmetics and drugs, from October 2019. Indonesia’s LPPOM MUI is regarded as one of the top 3 Halal certification agencies in the world along with Malaysia’s JAKIM and Singapore’s MUIS. To obtain certification from LPPOM MUI, it is required to meet strict conditions, including submitting safety documents and receiving site inspection on production and material management processes.
In particular, Halal certification for biologic drugs is stricter than that for synthetic drugs. In 2017, Daewoong Infion established a TFT designed to obtain Halal certification and has prepared for Halal certification on its original products and production facilities. As a result, the company obtained Halal certification for the erythropoietin (EPO) Epodion in January this year for the first time in the world as an animal cell-derived biologic, which is now followed by Easyef’s successful Halal certification.
Chang Woo Suh, CEO of Daewoong Infion, said, “Daewoong Pharmaceutical is implementing its ‘localization strategy’ where we do thorough research on emerging markets and develop products that accommodate their local needs to successfully make advances in such markets. Building on Halal certification for Epodion and Easyef from Indonesia, the largest Muslim country in the world, we will devote ourselves to advancing into the KRW 80 trillion Middle East pharmaceutical market, and providing good and safe drugs to many Muslims in the world.”
Daewoong Infion is a joint venture that Daewoong Pharmaceutical established in 2012 with the Indonesian company Infion. The joint venture completed Indonesia’s first biologic plant in Surabaya and is producing and selling Epodion, which accounts for the largest market share in the Indonesian erythropoietin (EPO) drugs market.
SOURCE Daewoong Pharmaceutical Co., Ltd