HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 2ACS DOBFAR SPA
03 1Akums Lifesciences
04 1Anhui Sinotech Industrial
05 1Asia Pioneer Pharmaceuticals
06 1Aurobindo Pharma Limited
07 1CSPC Pharmaceutical Group
08 1DEAFARMA
09 1Fresenius Kabi Anti-Infectives
10 2Grand Health Industrial Co Ltd
11 1HELM Portugal
12 2Hanmi Pharmaceutical
13 1Hanways Chempharm
14 1Kaliberr Labs
15 1Kopran
16 1Kyongbo Pharmaceutical Co., Ltd
17 1Lupin Ltd
18 1NCPC HUALUAN PHARMACEUTICAL CO LTD
19 1Nantong Chem-land
20 2Nectar Lifesciences
21 2Orchid Pharma
22 1Otto Brandes
23 2Qilu Antibiotics Pharmaceutical Co., Ltd.
24 1Qilu Pharmaceutical
25 1Qingdao Qingmei Biotech
26 1Reyoung pharmaceutical
27 2Sandoz B2B
28 1Sterile India Pvt. Ltd
29 1Tecoland Corporation
30 1Virchow Group
31 1Wockhardt
32 1Zhuhai United Laboratories Co ., Ltd.
01 13China
02 1Germany
03 13India
04 4Italy
05 1Portugal
06 3South Korea
07 2Switzerland
08 2U.S.A
01 5Active
02 8Inactive
03 26Blank
01 9Valid
02 7Withdrawn by Holder
03 23Blank
01 1224MF10209
02 38Blank
01 1WC-0090
02 1WC-0131-A
03 1WC-0131N
04 1WC-0145
05 1WC-0378A2
06 1WC-269
07 33Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14367
Submission : 1999-08-25
Status : Active
Type : II
Certificate Number : R1-CEP 1998-050 - Rev 03
Issue Date : 2008-02-28
Type : Chemical
Substance Number : 989
Status : Valid
NDC Package Code : 52946-0826
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15272
Submission : 2001-01-30
Status : Active
Type : II
NDC Package Code : 52946-0826
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17888
Submission : 2004-12-09
Status : Active
Type : II
Certificate Number : CEP 1999-033 - Rev 04
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 989
Status : Valid
Date of Issue : 2019-08-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131-A
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24748
Submission : 2011-03-10
Status : Active
Type : II
Certificate Number : R1-CEP 2011-226 - Rev 00
Issue Date : 2017-12-12
Type : Chemical
Substance Number : 989
Status : Valid
Date of Issue : 2016-09-06
Valid Till : 2019-07-02
Written Confirmation Number : WC-0145
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21202
Submission : 2007-12-27
Status : Active
Type : II
Certificate Number : R1-CEP 2000-047 - Rev 03
Issue Date : 2012-10-16
Type : Chemical
Substance Number : 989
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24892
Submission : 2011-04-18
Status : Inactive
Type : II
Certificate Number : R0-CEP 2012-227 - Rev 00
Issue Date : 2016-05-18
Type : Chemical
Substance Number : 989
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16839
Submission : 2003-09-09
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-182 - Rev 01
Issue Date : 2011-04-28
Type : Chemical
Substance Number : 989
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24793
Submission : 2011-03-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-224 - Rev 04
Issue Date : 2022-07-12
Type : Chemical
Substance Number : 989
Status : Valid
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2009-09-24
Registration Number : 20090924-118-G-24-01
Manufacturer Name : Kyungbo Pharmaceutical Co., Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12632
Submission : 1997-08-27
Status : Inactive
Type : II
Certificate Number : CEP 1999-161 - Rev 06
Issue Date : 2024-05-29
Type : Chemical
Substance Number : 989
Status : Valid
Registration Number : 224MF10209
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2012-10-29
Latest Date of Registration : --
Registrant Name : Hanmi Precision Chemical Co., Ltd.
Registration Date : 2009-09-24
Registration Number : 20090924-118-G-23-02
Manufacturer Name : Hanmi Precision Chemical Co., Ltd.
Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do
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