Friday, 03 April 2020

Daewoong Pharma achieves significant milestone

08 January 2020 | News

The achievement of MUI Halal certification for Epodion, the company's market leading erythropoietin product

image credit- istock.com

image credit- istock.com

Daewoong Infion Co. has achieved world's first halal certification for animal cells-derived biopharmaceuticals.

South Korean firm Daewoong Pharmaceutical Co., Ltd. has announced that Daewoong Infion, the company's joint venture with Infion, an Indonesian company, has obtained halal certification from The Assessment Institute for Foods, Drugs and Cosmetics, the Indonesian Council of Ulama (LPPOM MUI) for the joint venture's Erythropoietin (EPO) product, Epodion.

Daewoong Infion is a joint venture of Daewoong Pharmaceutical and an Indonesian company, Infion, that was formed in 2012. Indonesia's first biopharmaceutical plant has been constructed in Surabaya and is currently producing and selling Indonesia's first biosimilar drug, Epodion.

Epodion is an anemia treatment for dialysis patients with kidney failure and cancer patients, which obtained approval from Indonesian National Agency of Drug and Food Control (BPOM) in December 2016 and was launched in April 2017. Six months after its launch, the product has ranked 1st in Indonesia's EPO market and currently leading with over 40% of the market share.

Indonesia, which has the world's largest Muslim population in the world, implemented the Halal Product Guarantee Act in October 2019, which requires mandatory labeling of all foods, cosmetics, chemicals, and biological products that are halal certified. MUI, Indonesia's halal certification body, is one of the world's three largest halal certification bodies, along with Malaysia's JAKIM and Singapore's MUIS.

Daewoong Infion has been preparing to enter the global market through Halal certification in Indonesia based on Epodion's achievements. Following the product licensing of Epodion, Daewoong Infion formed a separate team to obtain its halal certification. As a result, after the halal certification application in October 2017 and going through a due diligence in 2019, within 2 years, the halal certification has been obtained. Obtaining a halal certification for synthetic drugs is known to be a very difficult procedure.

Based on halal certification, Daewoong Infion plans to obtain Halal certification for all products that are being produced in Indonesia, including Epidermal Growth Factor (EGF) and growth hormone-making Caretropine (Caretropin).

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