GMP inspection list by authorities
| Inspection Date |
Product Name |
Authorities |
| 2008 | Amiodarone Hydrochloride | CHINA NMPA |
| 2011.11.29-12.01 | Pranlukast Hydrate | JAPAN PMDA |
| 2014.11.18-11.20 | Amiodarone Hydrochloride | CHINA NMPA |
| 2016.08.30-09.01 | Mesalazine | JAPAN PMDA |
| 2018.04.24-04.26 | Amiodarone Hydrochloride | Korea MFDS |
| 2018.06.27-06.29 | Mesalazine | EDQM |
| 2019.12.20-12.22 | Amiodarone Hydrochloride | CHINA NMPA |
| Benserazide Hydrochloride |
Regulatory affairs
Many products have been registered domestically and overseas, and marketing approval have been obtained.
Domestic market
Amiodarone hydrochloride obtained marketing approval in 2008, and Mesalazine and Benserazide hydrochloride passed the domestic technical review in 2018, and have been associated with domestic FDF manufacturers, and the domestic market sales have gradually increased.
Foreign market
We have extensive overseas export experience, and our products are exported to overseas markets in large quantities.
Currently, four products have obtained CEP certificates, which are as follows:
2009, CEP certificate for Amiodarone HCl was obtained.
2013, CEP certificate for Tenoxicam was obtained.
2016, CEP certificate for Mesalazine was obtained.
2019, CEP certificate for Acemetacin was obtained.
After obtaining the CEP certificate, the products are widely sold in Europe, Japan, Asia, South America and other regions.
In addition, Carbocistein lysine was registered successfully in Italy and Spain.
Pranlukast, Mesalazine and Ticlopidine hydrochloride were successfully registered in Japan.
Amiodarone hydrochloride and Pranlukast were successfully registered in South Korea
Amiodarone hydrochloride and Ciprofibrate were successfully registered in Brazil.
Amiodarone hydrochloride and Tenoxicam were successfully registered in Russia
