DONG WHA PHARMACEUTICAL CO., LTD

As R&D activities are being activated and all of the production process are based on the GMP (Good Manufacturing Practice) standard, Dong Wha's medicines are recognized as high quality products in overseas markets.

The number of export products and importing countries are increasing every year and now some 30 kinds of raw material and some 20 kinds of finished products have been exported to some 40 countries including Germany, the United States, Great Britain, Switzerland, France and Japan after approval of registration under the strict standard. Dong Wha have received the honor awarded for the contribution to the national profit by the Government.

After LEE Woo Yong was appointed the 9th president in 1982 and HWANG Kyu Oun was named the 10th president in 1984 as both nonowner managers, Yoon Kil Joon becamed the 11th president, the present CEO, in 2003. Dong Wha established SANDOZ Korea Ltd. a joint venture company with SANDOZ (NOVARTIS as of now) in 1984, and the factory qualified for a KGMP approved in 1987 and was KGMP designated-company for the whole product range approved in 1991 and the company qualified for KGSP approved in 2001. On the other hand, as the building of the laboratory was newly-built and its organization was restructured constructively, Dong Wha marked the beginning of a new epoch in R&D and manufacturing activities.

On the other hand, in order to diversify the management multiply, Dong Wha launched LUBBOC, a bone graft developed by Transphyto (Thea as of now) in 1993, and established Dong Wha PODIATECH Center distributing medical device shoes for heteromorphy and deformation of foot, which have contributed to the improvement of QOL (Quality of Life) of patients.

Dong Wha also launched some food drinks such as Migrin fiver, Wang Gung Misukaru and Sang Sang Ton as going into the food business for the first time. And Dong Wha started the clinical study of Milican injection, radiopharmaceutical antitumor agent for liver cancer in Korea in 1997, the 100th anniversary of Dong Wha, and launched the Anox beau, a health-beauty drink. Dong Wha got into strategy cooperation agreement with Neo
Pharm, going into cosmetic business. Dong Wha got the approval of Milican injection, an epochal and world-first radiopharmaceutical antitumor agent for liver cancer from KFDA and got into technical cooperation agreement with XTL, Israel for the development of anti-Hepatitis C.

As the result, Dong Wha received the Korean management grand prize for the most excellent enterprise awarded from KMA in 1994, and in 1995, received Awarded Danish Prince Henrik's Medal of Honor and Diploma of the National Association for Danish Enterprise and Awarded Citizens'Order (Peony Award) on the occasion of Health and Social Welfare Day. In 1995, a 50th anniversary of the liberation from Japanese imperialism, Commemorative Stone for YUNTONG BU SEOUL (Seoul liaison department of Korea provisional government in Shanghai) erected in Head Office because the Head Office of Dong Wha was taking part in YUNTONG BU SEOUL, which informed a nation that Korea provisional government in Shanghai had been established, fighting against the Japanese imperialism, and sent all kind of information and war funds to Korea provisional government.

of Korea Records for being the first manufacturer and the first pharmaceutical company in Korea, for receiving the first registered trademark in Korea, and for the longest running medicine, WHAL MYUNG SU. Dong Wha marked the 100th anniversary first in Korea as manufacturer and pharmaceutical company. Dong Wha was awarded “Prize for Economy-Justice Enterprise” in 2000, and “Dasan Technical Prize”and“Prize for Clean Management and Environment” in 2001. In 2002, as Milican injection, an epochal and world-first radiopharmaceutical antitumor agent for liver cancer was selected as Top 10 of new technologies in Korea, Dong Wha received the certificate from the Minister of Commerce, Industry and Energy. And Dong Wha received the “Prize for New Drug Development” and 5th “Prize for Industry Cooperation” from the Prime Minister.

Dong Wha and Procter & Gamble Pharmaceuticals, Inc (P&GP), a subsidiary of The Procter & Gamble Company (NYSE: PG), announced a strategic alliance under which P&GP will have rights to develop and commercialize a novel class of molecules for the treatment of osteoporosis. The agreement includes Dong Wha's novel drug DW1350 and a family of back up compounds.

Under the terms of agreement, Dong Wha will receive an upfront fee, development and commercial milestone payments, and royalties on product sales. Total payments, excluding royalties, for successful development and commercialization of products, including DW 1350, could reach $511 million.

Dong Wha Pharm has completed building an international standard cGMP plant in Chungju. The new plant has total area of 82,500㎡, total floor space of 52,800㎡ including one basement level and four stories high, and total construction expense was approximately 130 billion won and it took 2 years to complete. The plant is the largest unitary pharmaceutical manufacturing plant in Korea and it is installed with brand new production lines, fully automated warehouse, and many welfare facilities.

Also the plant has excellent efficient manufacturing system based on cutting edge production line, which follows cGMP roadmap for all the medicine forms, and for the software-wise, strict quality guarantee system is installed.

Therefore, Dong Wha expects to become global pharmaceutical company and to lead the pharmaceutical industry to the next level, by increased exportation of finished products and APIs, and by successful commercialization of new compound, which is in P2 study and by searching for new global market.

Dong Wha Pharm is rushing on investment to R&D on the strength of the laboratory’s rebuilding and relocation. Dong Wha Pharm held research institute dedication ceremony at 699, Gong-se dong, Giheung gu, Yongin si. The size of land is 22,287m²(Approximately 6,742 pyeong), the floor space is 9,387m²(Approximately 2,840 pyeong), and the number of stories is 5 from the first basement level to 4th floor. The new research institute is designed to eco-friendly and energy saving facility, and has a key infrastructure regarding to R&D, such as research building for developing new medicines, the building for animal test, and the research lab for material composition.

New research institute is expected to become a base for globalization of Dong Wha and arouse sensational wind to pharmaceutical market by calm and aggressive investment on R&D.

Dong Wha Pharm received EU GMP(Good Manufacturing Practice) certificate for Pantoprazole(Active Pharmaceutical Product) manufactured at Chungju cGMP Plant . This inspection was performed by INFARMED which is the competent authority of Portugal, and the certification was granted after 6 months from the two-day inspection on May 2010.

EU requires an on-sight inspection of production facility of medicinal products, and EU members are mutually approving the EU GMP certificate from another member. Therefore, EU GMP certificate is compulsory qualification to export medicinal products to EU countries. Dong Wha Pharm expects that this acquisition of EU GMP certificate enable to expand its exports to European countries.