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Amerigen History 愛美津歷史
In 2007, Amerigen Inc., the US Corporate Headquarters of Amerigen LTD were founded. Also in 2007, Amerigen LTD purchased the facility at 58 Qun Xing Yi Lu from Tang Pharmaceutical Co. LTD and founded the Suzhou Amerigen Company Limited. The original Senior Management team was primarily experts in the US Generic Pharmaceutical market and product development for US targeted generic products was undertaken. In 2009, Suzhou Amerigen received US FDA site approval for GMP pharmaceutical products manufacture.
2007年,愛美津公司,即愛美津有限公司美國公司總部正式成立。同樣在2007年,愛美津有限公司收購了唐氏藥業有限公司位于群星一路的工廠,并成立了蘇州愛美津制藥有限公司。原始的高級管理團隊,主要是由在美國仿制藥市場和針對美國仿制藥進行產品開發的專家組成。2009年,蘇州愛美津獲得美國藥監局關于GMP藥品生產的審批。
Since that time four oral solid dosage product (US ANDAs) have been completely developed, manufactured, and tested at Suzhou Amerigen (SAPCL). Additionally, products which could not be developed at Suzhou Amerigen for strategic business reasons were supported (both formulation and analytical) by Suzhou Amerigen though manufactured at contractors.
自此以后,蘇州愛美津(SAPCL)已經自行開發、制造、測試4個口服固體制劑產品(美國簡化新藥申請)。此外,由于戰略業務的原因而不能在蘇州愛美津開發的產品(包括處方和分析),由承包商來制造。
During periods in 2011-2012, and again in 2015, strategic capital equipment investments and upgrades were made to ensure that Suzhou Amerigen can manufacture more complicated pharmaceutical process products at the highest quality.
在2011-2012年期間,隨后又在2015年,蘇州愛美津進行了戰略性固定設備投資和升級,以確保在最高質量要求下,制造具有更復雜制藥工藝的產品。
In 2012, the CFDA inspected the facility and granted the facility approval against the 2010 GMP regulations. The site was among the first facilities locally approved to the new regulations. In 2013, Suzhou Amerigen received another positive US FDA Inspection. Positive feedback from the investigators included “when I enter into this facility, I no longer feel like I’m in China.” Business visitors often comment that “from a compliance perspective, this facility’s among the best in China.”
2012年,中國藥監局對工廠進行了現場檢查,并依據2010新版GMP法規授予批準證書。蘇州愛美津是根據中國新版GMP獲批的首批工廠。2013年,蘇州愛美津接受了美國藥監局的另一次檢查。檢察官的正面反饋中包括:“當我進入到這個工廠,我不再覺得我在中國。”商務訪客常常評論說:“從合規的角度來看,這家工廠在中國是名列前茅的。”
In March 2014, Amerigen received US FDA first generic approval for the form of Carbidopa Tablets which is manufactured at Suzhou Amerigen.
2014年3月,美國藥監局批準在蘇州愛美津制造的卡比多巴片劑是首仿藥。
The purchase of the Suzhou Amerigen facility included 9 China Domestic Product Licenses. In 2014, Suzhou Amerigen started the process of reintroduction of the “Tang” products, after re-validating them to a standard consistent with U.S. expectations. This action led to the reintroductions of Mecobalamin Tablets, 0.5mg, Metoprolol Tartrate Tablets, 25 and 50 mg, and in 2015, Itopride Tablets, 50mg. The other five product licenses for China are still available for distribution partnerships and remain in the evaluation phase for reintroduction.
蘇州愛美津的收購中包括9個產品的中國國內生產許可證。2014年,蘇州愛美津開始著手唐氏產品工藝再造,通過再驗證使之滿足美國標準。這一行動決定了甲鈷胺片0.5mg,酒石酸美托洛爾片25和50毫克的再生產,并在2015年,再生產了伊托必利片50毫克。對于中國市場的其他五個產品許可證仍然可以與分銷商進行合作,仍然處于再生產評估階段。
Suzhou Amerigen welcomes strategic business development arrangements that can be mutually beneficial. With Business Development teams based both in the US and in China, and with experience in both markets, Suzhou Amerigen and Amerigen Inc. are positioned to deliver.
蘇州愛美津歡迎可以互惠互利的企業發展戰略合作。蘇州愛美津和愛美津公司位于中美兩國的業務開發團隊,并在這兩個市場的經驗為基礎的商業開發團隊將竭誠提供服務。