发展历史(History)

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上海现代制药海门有限公司:

2010

2月? Founded Shanghai Shyndec Pharmaceutical (Haimen) Co., Ltd. 上海现代制药海门有限公司成立

2013

10月? Obtain production license 获得生产许可证

2014

7月? Passed USFDA on-site audit 通过USFDA现场审核

2015

8月 Passed ANVISA GMP on-site audit 通过ANVISA GMP认证

10月 Passed the high-tech enterprise certification for the first time 首次通过高新技术企业认证

12月 Passed WHO PQ on-site audit 通过WHO PQ认证

2016

2月? Zidovudine Drug Approval Number approval 取得齐多夫定药品批准文号

10月 Chinese Zidovudine GMP certificate approval 取得齐多夫定GMP证书

11月 Identified as provincial engineering technology research center 认定为省级工程技术研究中心

2017

4月 Azithromycin Drug Approval Number approval 取得阿奇霉素药品批准文号

8月 Passed Russian GMP on-site audit 通过俄罗斯GMP认证

Azithromycin GMP certificate approval 取得阿奇霉素GMP证书

Azithromycin and L-alpha-GlycerophosphorylCholine were identified as provincial high and new technology products 阿奇霉素、L-α-甘油磷酰胆碱被认定为省级高新技术产品

11月 Passed the second level review of safety production standardization 通过安全生产标准化二级评审

12月 Passed the intellectual property management system certification for the first time 首次通过知识产权管理体系认证

Azithromycin CEP certificate approval 取得阿奇霉素CEP证书

Azithromycin and Zidovudine USFDA approval 阿奇霉素、齐多夫定通过USFDA现场审核

2018

7月 Passed ISO9001, ISO14001, ISO45001 on-site audit 通过ISO9001,ISO14001,ISO45001 认证

8月 Zidovudine registered in WHO齐多夫定WHO成功注册

10月 Identified as provincial enterprise technology center 认定为省级企业技术中心

11月 Passed the high-tech enterprise recertification 通过高新技术企业再认证

2019

11月? Nebivolol hydrochloride registered in CDE API Registration platform 完成盐酸奈必洛尔国内原料药登记

 

江苏威奇达药业有限公司

2020

10月 Renamed Jiangsu Weiqida Pharmaceutical Co., Ltd.更名为江苏威奇达药业有限公司

12月 Passed the second level review of safety production standardization 通过安全生产标准化二级评审

Passed the intellectual property management system recertification 通过知识产权管理体系再认证

2021

1月 Identified as Nantong City industrial Internet integration innovation pilot demonstration 认定为南通市工业互联网融合创新试点示范

7月 Nebivolol hydrochloride export certificate approval 取得盐酸奈必洛尔出口销售证明

8月 Passed ISO9001, ISO14001, ISO45001 on-site audit 通过ISO9001,ISO14001,ISO45001再认证

11月 Passed the high-tech enterprise recertification 通过高新技术企业再认证

“Azithromycin process optimization Project” won the second prize of Science and Technology Achievement Award of China Pharmaceutical Group 《阿奇霉素工艺优化项目》获得中国医药集团科技成果奖二等奖

12月 Identified as 2021 Nantong special new technology small giant enterprise 认定为2021年度南通市专精特新科技小巨人企业

Azithromycin was identified as the special new product of Jiangsu Province 阿奇霉素被认定为江苏省专精特新产品

2022

7月 Abacavir sulfate CEP certificate approval 取得硫酸阿巴卡韦CEP证书

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