煙臺(tái)萬(wàn)潤(rùn)藥業(yè)有限公司成立于2012年，是由中節(jié)能萬(wàn)潤(rùn)股份有限公司（股票代碼：002643）投資的全資子公司，是一家專業(yè)從事原料藥和口服固體制劑及保健食品的研制、生產(chǎn)與銷售的綜合型制藥企業(yè)。
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.
現(xiàn)有的原料藥合成車間按照2010年新版GMP標(biāo)準(zhǔn)建成的，占地面積約1700平方米，建筑面積約7200平方米，內(nèi)建有符合GMP生產(chǎn)要求的百公斤級(jí)生產(chǎn)線三條，公斤級(jí)和克級(jí)生產(chǎn)線各一條，可滿足不同批量產(chǎn)品的生產(chǎn)需要。另建有潔凈度為D級(jí)的潔凈區(qū)四個(gè)，滿足產(chǎn)品精制、烘干、包裝在潔凈環(huán)境下的需要，原料藥年生產(chǎn)能力可達(dá)100噸。公司于2010年向FDA提交了第一個(gè)DMF，注冊(cè)號(hào)為24019；公司已取得日本政府頒發(fā)的醫(yī)藥品外國(guó)制造者認(rèn)定證書，認(rèn)定號(hào)為AG10500451。
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.
新GMP合成車間于今年正式開(kāi)始啟用，原料藥年產(chǎn)能預(yù)計(jì)超過(guò)200噸。
The new GMP synthesis workshop will be officially launched in 2021, and the annual capacity of API is expected to exceed 200 tons.
公司具有一流的藥品研發(fā)和質(zhì)量管理團(tuán)隊(duì)，現(xiàn)已有多個(gè)原料藥品種順利通過(guò)日本及國(guó)內(nèi)的官方審計(jì)，與歐美客戶合作開(kāi)發(fā)的新品種也計(jì)劃通過(guò)WHO、EMA認(rèn)證。公司始終秉承“質(zhì)量第一”“客戶至上”的原則與理念，充分利用高端研發(fā)和硬件技術(shù)的優(yōu)勢(shì)，打造高標(biāo)準(zhǔn)的醫(yī)藥產(chǎn)品服務(wù)平臺(tái)。
The company has a? top-ranking R&D and quality management team. As of now, several APIs have successfully passed inspections of PMDA and NMPA, and new varieties developed in cooperation with European and American clients are also planned to apply for WHO and EMA certification. The company always adheres to the principles and concepts of 'Quality First' and 'Customer First', with the advantages of high-end R&D and hardware technology to create a high-standard pharmaceutical service platform.