HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1ACS DOBFAR SPA
03 1Akums Lifesciences
04 2Astellas Pharma
05 2Aurobindo Pharma Limited
06 1CSPC Pharmaceutical Group
07 1Covalent Laboratories Private Limited
08 1Dhanuka Laboratories Ltd
09 1Drug Manufacturing Company
10 1Freemen Nutra
11 1Hanmi Pharmaceutical
12 1Hengdian Group
13 1Kyongbo Pharmaceutical Co., Ltd
14 1Lupin Ltd
15 2Nectar Lifesciences
16 1Nishchem International Pvt. Ltd
17 2Orchid Pharma
18 1Orchidia Pharmaceutical Ind.
19 1Otto Brandes
20 1Pfizer Inc
21 2Qilu Antibiotics Pharmaceutical Co., Ltd.
22 1Qilu Pharmaceutical
23 1SURYA PHARMACEUTICAL LTD.
24 3Sandoz B2B
25 1Sichuan Renan Pharmaceutical
26 1Sneha Medicare Pvt Ltd
27 1Suzhou Tianlu Bio-pharmaceutical Co., Ltd
28 1Unimark Remedies Limited
29 1Virchow Group
30 1Zhejiang Apeloa Tospo Pharmaceutical Co. Ltd
01 9China
02 1Egypt
03 1Germany
04 16India
05 1Italy
06 2Japan
07 1Oman
08 2South Korea
09 3Switzerland
10 1U.S.A
01 9Active
02 6Inactive
03 22Blank
01 12Valid
02 3Withdrawn by EDQM Failure to CEP procedure
03 6Withdrawn by Holder
04 16Blank
01 1217MF10415
02 1222MF10120
03 1224MF10092
04 1226MF10199
05 1302MF10060
06 32Blank
01 1WC-0008
02 1WC-0023
03 1WC-0120
04 1WC-0131
05 1WC-0145
06 1WC-0190
07 1WC-0342
08 1WC-269
09 1WC0131
10 28Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-29
Pay. Date : 2014-02-25
DMF Number : 23474
Submission : 2010-01-18
Status : Active
Type : II
Certificate Number : R1-CEP 2009-005 - Rev 01
Issue Date : 2022-01-13
Type : Chemical
Substance Number : 1188
Status : Valid
Date of Issue : 2022-05-17
Valid Till : 2025-05-16
Written Confirmation Number : WC-0008
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-28
Pay. Date : 2016-10-19
DMF Number : 27121
Submission : 2013-04-29
Status : Active
Type : II
Certificate Number : CEP 2023-014 - Rev 00
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 1188
Status : Valid
Date of Issue : 2019-09-03
Valid Till : 2022-09-03
Written Confirmation Number : WC-0190
Address of the Firm :
NDC Package Code : 61788-3000
Start Marketing Date : 2015-04-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Withers Pharmaceutical Co., Ltd.
Registration Date : 2016-08-09
Registration Number : 20130710-26-A-286-09(2)
Manufacturer Name : Covalent Laboratories Pvt. Ltd.
Manufacturer Address : Sy.No.374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District - 502 296, Telangana State, India.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25390
Submission : 2011-09-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27033
Submission : 2013-04-03
Status : Inactive
Type : II
Certificate Number : R0-CEP 2014-217 - Rev 00
Issue Date : 2016-12-02
Type : Chemical
Substance Number : 1188
Status : Withdrawn by Holder
Registration Number : 224MF10092
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2012-04-25
Latest Date of Registration : --
Certificate Number : R1-CEP 2002-155 - Rev 06
Issue Date : 2019-07-02
Type : Chemical
Substance Number : 1188
Status : Valid
Registration Number : 217MF10415
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2005-08-19
Latest Date of Registration : --
Registrant Name : Hanmi Precision Chemical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-26-A-54-02
Manufacturer Name : Hanmi Precision Chemical Co., Ltd.
Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do
Certificate Number : R0-CEP 2007-314 - Rev 00
Issue Date : 2010-01-21
Type : Chemical
Substance Number : 1188
Status : Withdrawn by EDQM F...
Date of Issue : 2019-07-22
Valid Till : 2022-07-20
Written Confirmation Number : WC0131
Address of the Firm :
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2022-05-31
Registration Number : 20050831-26-A-56-03(6)
Manufacturer Name : Orchid Pharma Limited
Manufacturer Address : Plot No's. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial EstateAlathur, Kancheepuram District-603110, India
Certificate Number : CEP 2019-162 - Rev 01
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 1188
Status : Valid
Registration Number : 302MF10060
Registrant's Address : No. 519 Jiangnan Road, Hengdian Industrial Zone, Dongyang City, Jinhua, Zhejiang Province, China
Initial Date of Registration : 2020-05-25
Latest Date of Registration : --
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