烟台万润药业有限公司成立于2012年,是由中节能万润股份有限公司(股票代码:002643)投资的全资子公司,是一家专业从事原料药和口服固体制剂及保健食品的研制、生产与销售的综合型制药企业。
现有的原料药合成车间按照2010年新版GMP标准建成的,占地面积约1700平方米,建筑面积约7200平方米,内建有符合GMP生产要求的百公斤级生产线三条,公斤级和克级生产线各一条,可满足不同批量产品的生产需要。另建有洁净度为D级的洁净区四个,满足产品精制、烘干、包装在洁净环境下的需要,原料药年生产能力可达100吨。公司于2010年向FDA提交了第一个DMF,注册号为24019;公司已取得日本政府颁发的医药品外国制造者认定证书,认定号为AG10500451。
Yantai Valiant Pharmaceutical Co., Ltd, founded in 2012, is a wholly owned subsidiary of CECEP Valiant Co., Ltd.(Stock code:002643)and a pharmaceutical enterprise specializing in development, manufacture and marketing of API, oral solid preparation and the health care products.
The current chemical synthesis workshop was built as per the GMP standard (2010 vision) covering an area of 1700 square meters, and its construction area is 7200 square meters. The workshop has separated three hundred-kilogram level production suites, one kilogram-level and one gram-level production lines based on GMP requirements to manufacture various scales of APIs and intermediates. In addition, four Grade D clean areas are in place to satisfy the needs of products purification, drying and packaging in clean environments. Our API production capacity could reach 100 tons annually. In 2010, we submitted the first DMF to FDA with the registration number 24019. We have acquired Accreditation Certificate of Foreign Drug Manufacturer issued by Japanese government with the number AG10500451.