NEWS CENTER
新闻资讯
美国药监局审计
FDA Inspection
门冬酰胺酶使肿瘤细胞中门冬酰胺水解为门冬氨酸和氨，从而使肿瘤细胞因缺乏门冬酰胺而被抑制生长。常州千红严格按照中国GMP规范生产门冬酰胺酶，重庆骏强多年来一直从常州千红采购门冬酶并直接或间接销售到印度市场。但是香港安城药业未经我司任何授权于2015年在美国注册门冬酶NDC号并以其名义在美国非法销售，在2016年又擅自在美国FDA以我司名义注册NDC号并以我司名义在美国非法销售。直到2018年8月美国FDA通知，我司才发现上述侵权行为，并立即向安城发出律师函，要求安城药业停止侵权，停止在美以我司名义非法销售并注销我司在FDA注册的NDC号。尽管如此，该事件还是触发了美国FDA于2019年3月18-22日对我司进行审计。在审计中FDA确认了我司门冬酶贸易事实，并发现我司在贸易活动中唯一的缺陷：分析单出具不符合ICH Q7中第17章对贸易活动的GMP管理规定。虽然我们按时向 FDA 国际审计部门递交了纠正措施回复，但 FDA 药品评审部门好像没有收到我们的回复从而引发美国的进口预警。公司目前已完成NDC号注销工作，停止了所有门冬酶的销售并正全力配合美国FDA调查，争取早日完成预防纠正措施，取消进口预警。
Asparaginase is an enzyme which is used in the body to speed up the change of asparagine in cancer cells into products called aspartic acid and ammonia. Therefore the cancer cells are not able to grow and reproduce because the asparagine is turned into aspartic acid and ammonia by the administration of asparaginase. Asparaginase API is produced under strict GMP by Changzhou Qianhong and supplied by us to Indian market for many years. However Anchang Pharma in Hongkong registered NDC number with US FDA under her own name during 2015 - 2016 and had been selling in US illegally without any authorization or permission from us. This company even further registered NDC number with US FDA in our name without our knowledge or permission, and had been selling illegally in US market during 2016 to 2018 till we found out the truth from US FDA in September 2018. Our lawyer sent Ancheng letter once we found out the infringement, requesting them to stop selling in US and de-register our NDC number with US FDA. However inspection by FDA was still triggered off. The inspection was carried out during 18 -22 March 2019, trading activity was confirmed during inspection and one observation was cited in Form 483: CoA issuance did not comply with GMP specified in Chapter 17 of ICH Q7. Response to observation cited in form 483 was submitted to and confirmed by FDA Office of Pharmaceutical Quality Operation (OPQO) on 13th of April 2019. However it appears that the response was not forwarded to FDA Office of Compliance – Office of Manufacturing Quality (CDER-OC-OMQ), which caused CDER-OC-OMQ to place us on Import Alert on 1st of August 2019 due to lack of receipt of our response to observation cited in form 483 by this office. De-registration of our NDC number was finished in 2018 to stop the infringement illegal sales by Ancheng in USA market. Both electronic and hard copy of our response to Form 483 was re-submitted to CDER-OC-OMQ on 23rd of August 2019 and hopefully Import alert is removed within short.
