HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1ACS DOBFAR SPA
03 1Asia Pioneer Pharmaceuticals
04 2Aurobindo Pharma Limited
05 1Beijing Fukangren Biopharmaceutical
06 1Bristol Myers Squibb
07 1CSPC Pharmaceutical Group
08 1CordenPharma
09 1DMFs Not Supported
10 2Fresenius Kabi Anti-Infectives
11 1Fujifilm Toyama Chemical
12 1Hospira, Inc.
13 1Inner Mongolia Changsheng Pharmaceutical
14 3Istituto Biochimico Italiano Giovanni Lorenzini SpA
15 1Jeil Pharmaceutical Co., Ltd
16 1Jiangxi Fushine Pharmaceutical Co. Ltd
17 1North China Pharmaceutical Co., Ltd.
18 1Orchid Pharma
19 1Pfizer Inc
20 1Qilu Antibiotics Pharmaceutical Co., Ltd.
21 1Qilu Pharmaceutical
22 3Qilu Tianhe Pharmaceutical Co., Ltd.
23 1Rajasthan Antibiotics
24 1Reyoung pharmaceutical
25 1Sandoz B2B
26 1Shandong Anxin Pharmaceutical
27 1Shandong Ruiying Pioneer Pharmaceutical
28 1Yuhan Corporation
29 2Blank
01 13China
02 1Germany
03 5India
04 6Italy
05 1Japan
06 2South Korea
07 1Switzerland
08 4U.S.A
09 3Blank
01 9Active
02 5Inactive
03 22Blank
01 9Valid
02 4Withdrawn by Holder
03 23Blank
01 1217MF10591
02 1218MF10914
03 1220MF10105
04 1226MF10079
05 1226MF10106
06 1226MF10126
07 1226MF10154
08 1226MF10162
09 1228MF10083
10 1229MF10058
11 1229MF10208
12 1301MF10043
13 1304MF10055
14 23Blank
01 1WC-0098
02 1WC-0420
03 1WC-0430
04 33Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16841
Submission : 2003-09-15
Status : Active
Type : II
Certificate Number : R1-CEP 2004-206 - Rev 05
Issue Date : 2021-06-08
Type : Chemical
Substance Number : 1169
Status : Valid
NDC Package Code : 66721-300
Start Marketing Date : 2003-11-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Yuhan Chemical Co., Ltd.
Registration Date : 2012-07-27
Registration Number : 20120727-95-E-104-02
Manufacturer Name : Yuhan Chemical Co., Ltd.
Manufacturer Address : 5-ba 402, Sihwa Industrial Complex, 678-1, Seonggok-dong, Danwon-gu, Ansan-si, Gyeonggi-do
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35825
Submission : 2021-04-29
Status : Active
Type : II
Registration Number : 304MF10055
Registrant's Address : Industry Zone, Tuoketuo, Hohhot, Inner Mongolia, China
Initial Date of Registration : 2022-03-16
Latest Date of Registration : --
NDC Package Code : 32903-098
Start Marketing Date : 2023-11-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-11
Pay. Date : 2018-03-27
DMF Number : 23614
Submission : 2010-03-11
Status : Active
Type : II
Certificate Number : R1-CEP 2010-211 - Rev 02
Issue Date : 2021-08-30
Type : Chemical
Substance Number : 1169
Status : Valid
Registration Number : 226MF10126
Registrant's Address : No. 1777 Kunming Road, Mudan District, Heze City, Shandong Province, People's Republic of China
Initial Date of Registration : 2014-07-01
Latest Date of Registration : --
NDC Package Code : 50915-118
Start Marketing Date : 2010-06-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (60kg/60kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10112
Submission : 1980-04-30
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10133
Submission : 1982-02-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 2015-389 - Rev 00
Issue Date : 2022-04-22
Type : Chemical
Substance Number : 1169
Status : Valid
Registrant Name : DL Bio Korea Co., Ltd.
Registration Date : 2022-02-22
Registration Number : 20180702-95-E-133-06(2)
Manufacturer Name : Shandong Anxin Pharmaceutical Co., Ltd @[Starting material 'Piperacillin' manufacturer] Shandong Anshun Pharmaceutical Co., Ltd
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan City, Shangdong Province PR China@Circular Economy Demonstration Park, Laoling County, Dezhou City, Shandong Province, PRChina
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2019-153 - Rev 02
Issue Date : 2024-07-31
Type : Chemical
Substance Number : 1169
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R1-CEP 2012-101 - Rev 03
Issue Date : 2023-03-20
Type : Chemical
Substance Number : 1169
Status : Valid
Certificate Number : CEP 2006-252 - Rev 04
Issue Date : 2024-01-19
Type : Chemical
Substance Number : 1168
Status : Valid
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