According to arrangements of the China Food and Drug Administration, the following drugs are classified into the overseas on-site inspection for imported drugs in 2017. Center for Food and Drug Inspection of CFDA is responsible for the organization and implementation of relevant inspections. The on-site inspection is not only limited to the following drugs. If any supplement, further announce.
Center for Food and Drug Inspection of CFDA
Mar. 8, 2017
|
No. |
Variety Name |
Acceptance No./Import Registration Certificate No. |
Company Name |
Registered Agency |
Remarks |
|
1 |
Esculin and digitalis glycosides eye drops |
H20130295 |
Pharma Stulln GmbH |
Shenzhen China Medical System Holding Ltd. |
Task switching from last year |
|
2 |
Alglucosidase Alfa injection |
JXSS1500008 |
Genzyme Europe B.V. |
Sanofi (China) Investment Ltd. |
Task s witching from last year |
|
3 |
Recombinant human erythropoietin injection |
JXSS1300003 |
Shanghai Roche Pharmaceuticals Ltd. |
Shanghai Roche Pharmaceuticals Ltd. |
Task switching from last year |
|
4 |
Peginterferon alfa-2a solution for injection |
S20120048/50 |
Roche Pharma (Schweiz) Ltd. |
Shanghai Roche Pharmaceuticals Ltd. |
Task switching from last year |
|
5 |
Rituximab injection |
JYSB1200281/2/3/4 |
Roche Pharma (Schweiz) Ltd. |
Shanghai Roche Pharmaceuticals Ltd. |
Task switching from last year |
|
6 |
Recombinant Follitropin beta injection |
JYSB1100190/191/192 |
Merck Sharp & Dohme Limited |
Merck Sharp & Dohme (China) Ltd. |
Task switching from last year |
|
7 |
Ganirelix Injection |
JXHS1100069 |
N.V. Organon |
Beijing Representative Office, Bermuda Schering (China) Ltd. |
Task switching from last year |
|
8 |
Epirubicin hydrochloride injection |
H20120389 |
Ebewe Pharmaceutical Ltd. |
Ebewe Pharmaceutical Ltd. |
Task switching from last year |
|
9 |
Triptorelin acetate injection |
JYHB1400771 |
Ferring AG |
Ferring Medical Consulting(Shanghai) Ltd. |
Task switching from last year |
|
10 |
Amiodarone hydro chloride injection |
H20120497 |
Sanofi-Aventis France |
Sanofi-Aventis (China) Investment Ltd. |
Task switching from last year |
|
11 |
Human albumin |
S20120070 |
Switzerland CSL Behring Biological Products Ltd |
Beijing Branch, CSL Behring (Shanghai) Medical Consulting Co., Ltd. |
Task switching from last year |
|
12 |
Human albumin |
JYSB1200245 |
American CSL Behring Biological Products Ltd |
Hangzhou Tigermed Consulting Co., Ltd |
|
|
13 |
Cefoperazone sodium injection |
H20100495 |
Medochemie Ltd. |
Beijing PHDS Medical Technologies Ltd. |
|
|
14 |
Fluconazole Capsules |
H20110496 |
Medochemie Ltd. |
Beijing PHDS Medical Technologies Ltd. |
|
|
15 |
Ademetionine 1,4-butanedisulfonate injection |
H20140261 |
ABBOTT S.R.L. |
Abbott Trading (Shanghai) Co., Ltd |
|
|
16 |
Tramadol hydrochloride sustained-release tablets |
H20120382 |
Mundipharma GmbH |
Mundi (China) Pharmaceuticals Ltd |
|
|
17 |
Fluphenazine Decanoate Injection |
H20150237 |
Atlantic Laboratories Corporation, Ltd. |
Hainan Atlantic Pharmaceuticals Ltd |
|
|
18 |
Imipenem and Cilastatin Sodium |
H20100699 |
Ranbaxy Laboratories Limited |
Beijing Representative Office, India Ranbaxy Laboratories Ltd |
|
|
19 |
Human albumin |
S20140106 |
Spanish Grifols Ltd |
Hangzhou Tigermed Inc. |
|
|
20 |
Ranibizumab Injections (prefilled) |
S20160002 |
Novartis Pharma Schweiz AG |
Beijing Novartis Pharmaceuticals Ltd |
|
|
21 |
Glycopyrronium bromide inhalation powder capsules |
JXHS1600048 |
Novartis Europharm Limited |
Beijing Novartis Pharmaceuticals Ltd |
|
|
22 |
Ruxolitinib Phosphate tablets |
JXHS1500114-119 |
Novartis Europharm Limited |
Beijing Novartis Pharmaceuticals Ltd |
|
|
23 |
Rabies Vaccine(Chicken Embryo Cell)for Human Use |
S20150044 |
Chiron Behring Vaccines Private Ltd |
Shanghai Keyuanxinhai Pharmaceutical Co., Ltd |
|
|
24 |
Recombinant Human Coagulation Factor Ⅷ For Injection |
JYSZ1600013-16 |
Baxter AG |
Baxalta Bio-technical (Shanghai) Ltd |
|
|
25 |
Tigecycline for Injection
|
H20110111 |
Pfizer Limited |
Wyeth Pharmaceuticals Ltd |
|
|
26 |
Indomethacin Vitamin E cream gel |
JXHS1500045 |
Teikoku Seiyaku Co., Ltd |
Beijing NovoTek Pharmaceuticals Ltd |
|
|
27 |
Exenatide microspheres for injection |
JXHS1600049 |
AstraZeneca AB |
Astrazeneca Investment (China) Ltd |
|
|
28 |
Sugammadex Sodium injection |
JXHS1600016/17 |
Merck Sharp & Dohme Limited |
MSD Research and Development (China) Ltd |
|
|
29 |
Sabal serrulata soft capsules
|
JYZZ1600008 |
Germany Strathmann GmbH& Co.KG |
Shanghai Nulife Pharmaceutical Co., Ltd |
|
|
30 |
Quetiapine Fumarate Tablets |
JXHS1100082 |
Dr. Reddy's Laboratories Ltd. |
SinoChem Jiangsu Co., Ltd |
|
|
31 |
Olanzapine |
JXHS1100084 |
NEULAND LABORATORIES LIMITED. |
Hangzhou Oriental Pharma Co., Ltd |
|
|
32 |
Crosslinked Sodium Hyaluronate Injection |
JXHS1500097 |
Genzyme Biosurgery |
Sanofi (China) Investment Ltd. |
|
|
33 |
Ambroxol hydrochloride |
JXHS1200014 |
shilpa Medicare limited |
Dalian Wista Pharma Co., Ltd |
|
|
34 |
:Pyrithione Zinc Aerosol |
H20140563 |
Cheminova Internacional S.A. |
Guangdong Etrawell- South Asia Pharmaceutical Ltd |
|
|
35 |
Swelling antipruritic liniment |
JYZZ1600011 |
Tai Tong Ah Company Pte Ltd |
Guangdong Dearstone Pharmaceutical Ltd |
|
|
36 |
Compound Camphor Oil |
JYZZ1600014 |
Haw Par Healthcare Limited |
Guangdong Guojian Medical Consulting Ltd |
|
|
37 |
Daptomycin for Injection |
H20150451 |
Cubist Pharmaceuticals,Inc. |
MSD Research and Development (China) Ltd |
|
|
38 |
Pidotimod oral solution |
JTH1400765/1500021/1500217/1500371 ， H20150635,H20090934 |
POLICHEM S.R.L. |
Beijing Representative Office, Switzerland Pli Chemical Industry Co., Ltd |
|
|
39 |
Multi-trace elements injection |
H20110522 |
LABORATOIRE AGUETTANT |
Shanghai Nulife Pharmaceutical Co., Ltd |
