Management System
Quality Management System
The company has established a relatively complete quality management system and passed the ISO9001/ISO14001/ISO45001 integrated management system certification.
The scope of the company's drug production license is raw materials, a total of 10 products have obtained registration numbers, a total of 9 products through GMP certification. The company's main products have been registered in the United States, the European Union, Canada, Russia, Brazil, South Korea, Japan, India and other countries and regions. The company has the right to import and export, and more than 85% of its products are exported. The company's main products are naproxen, naproxen sodium, acyclovir, etc. The production process is mature, the process technology is advanced, and the product production capacity, sales volume and quality level are in an international position. It is an important API supplier in the world. The company has experienced 5 U.S. FDA, 4 EU EDQM, 3 South Korea MFDS, 3 Brazilian ANVISA and other official on-site audits, and the results are all approved. At the same time, it has experienced many domestic and foreign customer audits every year, including on-site audits of world-renowned pharmaceutical companies.
|
Inspection Agency |
Audit time |
Audit Content (Product Scope) |
Results |
|
FDA |
2004.09 |
Naproxen Sodium |
By |
|
2008.09 |
Naproxen, Naproxen Sodium, Acyclovir |
By |
|
|
2011.09 |
Naproxen, Naproxen Sodium, Acyclovir, Valacyclovir Hydrochloride, Adefovir Dipivoxil Dimethyl Carbonate, Irinotecan Hydrochloride |
By |
|
|
2014.07 |
Acyclovir, Naproxen, Naproxen Sodium, Valacyclovir Hydrochloride, Adefovir Dipivoxil DMC, Valganciclovir Hydrochloride, Naproxen Sodium Granules, Ganciclovir |
By |
|
|
2018.01 |
Acyclovir, Naproxen, Penciclovir |
By |
|
|
EDQM |
2004.05 |
Naproxen, Acyclovir |
By |
|
2007.09 |
Naproxen, Acyclovir |
By |
|
|
2014.07 |
Naproxen |
By |
|
|
2016.10 |
Acyclovir |
By |
|
|
ANVISA |
2011.04 |
Acyclovir |
By |
|
2013.11 |
Acyclovir |
By |
|
|
2016.03 |
Acyclovir |
By |
|
|
MFDS |
2011.11 |
Acyclovir |
By |
|
2012.09 |
Naproxen, Naproxen Sodium |
By |
|
|
2016.07 |
Naproxen |
By |
|
|
COFEPRIS |
2014.01 |
Naproxen, Naproxen Sodium, Acyclovir, Ganciclovir, Valaciclovir Hydrochloride, Valganciclovir Hydrochloride, Clopidogrel Hydrogen Sulfate |
By |
|
2016.03 |
Naproxen, Naproxen Sodium, Acyclovir, Ganciclovir, Valaciclovir Hydrochloride, Valganciclovir Hydrochloride, Clopidogrel Hydrogen Sulfate |
By |