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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