한미약품은 창조와 도전을 기치로 신약개발에 매진하는 R&D중심 제약기업입니다.
Hanmi Bio Plant was established in 2007 and dedicated to biological medicines. In 2008 it was accredited with KGMP, and gained Hyaluronate product approval in 2008. In 2011 the facility and its Hyaluronate-based product was granted ISO 9001, ISO13485, and Directive 93/42/EEC certification by SGS. Qualified person audits for each product under clinical stage were performed and approvals were ontained.
Located in the same Pyeongtaek complex across from the Cepha Plant, the Bio Plant is a two-story construction with a basement level occupying 4,600m2 of land. There are dedicated areas for microbial related production finished product line, QC laboratories and warehousing. Plans are underway to expand production lines to accommodate anticipated growth of sales and product portfolio.
Clinical trials are underway for therapeutic areas and agents of: