Factory Building History
The plant started construction in May 2016 and was completed for trial operation in January 2017.
From February to April, 2017, the verification of plant facilities, equipment and instruments was carried out.
In April 2017, the pilot production with materials and the validation of analytical methods were carried out.
In May 2017, the on-site inspection of the drug production license was completed.
In June 2017, the comprehensive process verification was successful for the first time.
In July 2017, it passed the GMP on-site inspection smoothly.
In August 2017, the company completed the inspection of ISO90001 quality management system.
History of Regulatory Inspections
In 2004, the provincial food and drug administration salicylic acid GMP certification on-site inspection.
In 2005, aspirin GMP certification and salicylic acid review were conducted by the provincial food and drug administration.
From 2006 to 2009, the municipal food and drug administration conducted 12 routine inspections, special inspections and flight inspections.
In 2009, the provincial food and drug administration salicylic acid GMP certification on-site inspection again.
In 2010, aspirin GMP recertification site inspection by provincial food and drug administration.
In 2014, the provincial drug watchdog approved the new version of aspirin and medicinal acid GMP through on-site inspection.
From 2009 to 2014, j&j, reckitt, glaxosmithkline, SSL, KEMWELL, Japan xiaohua co., LTD., the United States things, the Netherlands fogg and many other customers on-site audit.
In 2017, the site acceptance inspection of the production license of cangzhou bureau was changed.
In 2017, the provincial food and drug administration conducted on-site inspection of the new version of aspirin and medicinal salicylic acid GMP certification.
Document Registration History
In 2008, completed the DMF file registration application. Registration number: aspirin 22594, salicylic acid 22595.
In 2009, the certificate was renewed for salicylic acid GMP certificate no.: JI K0445.
In 2010, obtained the certificate replacement aspirin GMP certificate no.: JI L0553.
In 2014, I obtained the new version of GMP certificate in the first round. The certificate number is HE20140087.
In June 2017, the new factory obtained the drug production license.Certificate no. : 91130131MA071217H7M.
In September 2017, the company obtained the certification certificate after passing the GMP on-site inspection of the new factory.
In September 2017, the company passed the ISO9001 international quality system certification of the new plant, certificate number: 00615Q21285R3L-4.