發展歷史(History)

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上海現代制藥海門有限公司:

2010

2月? Founded Shanghai Shyndec Pharmaceutical (Haimen) Co., Ltd. 上海現代制藥海門有限公司成立

2013

10月? Obtain production license 獲得生產許可證

2014

7月? Passed USFDA on-site audit 通過USFDA現場審核

2015

8月 Passed ANVISA GMP on-site audit 通過ANVISA GMP認證

10月 Passed the high-tech enterprise certification for the first time 首次通過高新技術企業認證

12月 Passed WHO PQ on-site audit 通過WHO PQ認證

2016

2月? Zidovudine Drug Approval Number approval 取得齊多夫定藥品批準文號

10月 Chinese Zidovudine GMP certificate approval 取得齊多夫定GMP證書

11月 Identified as provincial engineering technology research center 認定為省級工程技術研究中心

2017

4月 Azithromycin Drug Approval Number approval 取得阿奇霉素藥品批準文號

8月 Passed Russian GMP on-site audit 通過俄羅斯GMP認證

Azithromycin GMP certificate approval 取得阿奇霉素GMP證書

Azithromycin and L-alpha-GlycerophosphorylCholine were identified as provincial high and new technology products 阿奇霉素、L-α-甘油磷酰膽堿被認定為省級高新技術產品

11月 Passed the second level review of safety production standardization 通過安全生產標準化二級評審

12月 Passed the intellectual property management system certification for the first time 首次通過知識產權管理體系認證

Azithromycin CEP certificate approval 取得阿奇霉素CEP證書

Azithromycin and Zidovudine USFDA approval 阿奇霉素、齊多夫定通過USFDA現場審核

2018

7月 Passed ISO9001, ISO14001, ISO45001 on-site audit 通過ISO9001,ISO14001,ISO45001 認證

8月 Zidovudine registered in WHO齊多夫定WHO成功注冊

10月 Identified as provincial enterprise technology center 認定為省級企業技術中心

11月 Passed the high-tech enterprise recertification 通過高新技術企業再認證

2019

11月? Nebivolol hydrochloride registered in CDE API Registration platform 完成鹽酸奈必洛爾國內原料藥登記

 

江蘇威奇達藥業有限公司

2020

10月 Renamed Jiangsu Weiqida Pharmaceutical Co., Ltd.更名為江蘇威奇達藥業有限公司

12月 Passed the second level review of safety production standardization 通過安全生產標準化二級評審

Passed the intellectual property management system recertification 通過知識產權管理體系再認證

2021

1月 Identified as Nantong City industrial Internet integration innovation pilot demonstration 認定為南通市工業互聯網融合創新試點示范

7月 Nebivolol hydrochloride export certificate approval 取得鹽酸奈必洛爾出口銷售證明

8月 Passed ISO9001, ISO14001, ISO45001 on-site audit 通過ISO9001,ISO14001,ISO45001再認證

11月 Passed the high-tech enterprise recertification 通過高新技術企業再認證

“Azithromycin process optimization Project” won the second prize of Science and Technology Achievement Award of China Pharmaceutical Group 《阿奇霉素工藝優化項目》獲得中國醫藥集團科技成果獎二等獎

12月 Identified as 2021 Nantong special new technology small giant enterprise 認定為2021年度南通市專精特新科技小巨人企業

Azithromycin was identified as the special new product of Jiangsu Province 阿奇霉素被認定為江蘇省專精特新產品

2022

7月 Abacavir sulfate CEP certificate approval 取得硫酸阿巴卡韋CEP證書

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