Quality registration
Product Registration
Domestic CFDA registered varieties：
|
Serial number |
Varieties/formulations |
Drug name |
specifications |
Approval number |
Remark |
|
1 |
API |
Norfloxacin |
25kg/barrel |
SFDA approval number H33021898 |
Passed GMP certification |
|
2 |
Doxazosin mesylate |
/ |
SFDA approval number H20050006 |
Passed GMP certification |
|
|
3 |
Bromhexine hydrochloride |
/ |
SFDA approval number H20054652 |
Passed GMP certification |
|
|
4 |
Sertraline hydrochloride |
/ |
SFDA approval number H20057438 |
Passed GMP certification |
|
|
5 |
Fexofenadine hydrochloride |
/ |
SFDA approval number H20100013 |
Passed GMP certification |
|
|
6 |
Atorvastatin Calcium |
/ |
SFDA approval number H20103023 |
Passed GMP certification |
|
|
7 |
Tablet |
Atorvastatin Calcium Tablets |
10mg |
SFDA approval number H20133127 |
Passed GMP certification |
|
8 |
Atorvastatin Calcium Tablets |
20mg |
SFDA approval number H20163270 |
Passed GMP certification |
|
|
9 |
Sertraline Hydrochloride Tablets |
50mg |
SFDA approval number H20052202 |
Passed GMP certification |
|
|
10 |
Lacidophilin Tablets |
0.4g |
SFDA approval number H19999445 |
Passed GMP certification |
|
|
11 |
Oryzanol Tablets |
10mg |
SFDA approval number H33021397 |
Passed GMP certification |
|
|
12 |
Doxazosin Mesylate Tablets |
2mg |
SFDA approval number H20050083 |
Passed GMP certification |
|
|
13 |
Nevirapine Dispersible Tablets |
0.2g |
SFDA approval number H20052175 |
Passed GMP certification |
|
|
14 |
Capsule |
Norfloxacin Capsules |
0.1g |
SFDA approval number H33021396 |
Passed GMP certification |
|
15 |
Fexofenadine hydrochloride capsule |
60mg |
SFDA approval number H20100021 |
Passed GMP certification |
|
|
16 |
Granules |
Pediatric Paracetamol |
2g |
SFDA approval number H33022086 |
|
FDA registered varieties:
|
Serial number |
Description |
DMF file No. |
Remark |
|
1 |
Methohexitone |
17700 |
|
|
2 |
Adapalene |
18831 |
|
|
3 |
Atorvastatin sodium |
20535 |
Passed PDA certification |
|
4 |
Atorvastatin calcium intermediates L - 1 |
18835 |
Passed PDA certification |
|
5 |
Rosuvastatin calcium |
26022 |
Passed PDA certification |
|
6 |
Rosuvastatin calcium intermediates R - 1.5 |
20571 |
Passed PDA certification |
|
7 |
Rosuvastatin calcium intermediates RJS - 3 |
20677 |
Passed PDA certification |
|
8 |
Rosuvastatin calcium |
25781 |
Passed PDA certification |
|
9 |
Linezolid |
26962 |
|
|
10 |
Esomeprazole sodium |
29082 |
|
Other market registration:
|
Serial number |
Description |
Registered market |
Remark |
|
1 |
Norfloxacin |
The European Union, India, Russia, Japan, South Korea and Brazil |
CEP：2006-037 |
|
2 |
Atorvastatin calcium |
The European Union, Russia, India, South Korea and Japan |
CEP：2012-139 |
|
3 |
Rosuvastatin calcium |
European countries, Russia |
|
|
4 |
Bromhexine hydrochloride |
Japan, Russia |
|
|
5 |
Doxazosin mesylate |
Japan |
|
|
6 |
Atorvastatin sodium |
European Union countries |
Passed MHRA certification |
|
7 |
Linezolid |
European Union countries |
|