HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1Medichem S.A
03 1Alembic Pharmaceuticals Limited
04 1Anek Prayog Pvt. Ltd.,
05 1Arene Lifesciences
06 1Aurobindo Pharma Limited
07 1Changzhou Ruiming Pharmaceutical
08 1Cipla
09 1Emcure Pharmaceuticals
10 1Esteve Quimica
11 1Everlight Chemical
12 1HEC Pharm
13 1Hainan Poly Pharm
14 1Jiangsu Lianhuan Pharmaceutical
15 1Korea United Pharm. Inc.
16 1Nantong Chem-land
17 1Orchid Pharma
18 1Tecoland Corporation
19 1Wockhardt
20 1Yangzhou Pharmaceutical
21 1Yangzhou Pharmaceutical Factory
22 1Zhejiang Supor Pharmaceuticals Co., LTD
01 8China
02 9India
03 1South Korea
04 2Spain
05 1Taiwan
06 1U.S.A
01 7Active
02 9Inactive
03 6Blank
01 1Expired
02 7Valid
03 1Withdrawn by Holder
04 13Blank
01 1219MF10301
02 21Blank
01 1WC-0023
02 1WC-0082
03 1WC-0089
04 1WC-0113
05 18Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-28
Pay. Date : 2013-03-14
DMF Number : 14099
Submission : 1999-05-03
Status : Active
Type : II
Certificate Number : R1-CEP 2004-213 - Rev 01
Issue Date : 2012-05-18
Type : Chemical
Substance Number : 1013
Status : Valid
NDC Package Code : 53296-0041
Start Marketing Date : 2010-04-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-18
Pay. Date : 2013-09-03
DMF Number : 19449
Submission : 2006-05-16
Status : Active
Type : II
Certificate Number : R1-CEP 2011-175 - Rev 01
Issue Date : 2020-12-04
Type : Chemical
Substance Number : 1013
Status : Valid
NDC Package Code : 14799-2007
Start Marketing Date : 2010-08-16
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 : 25405
Submission : 2011-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21051
Submission : 2007-11-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12248
Submission : 1996-12-04
Status : Inactive
Type : II
Certificate Number : CEP 1996-090 - Rev 06
Issue Date : 2024-10-15
Type : Chemical
Substance Number : 1013
Status : Valid
Registrant Name : Handok Co., Ltd.
Registration Date : 2012-08-06
Registration Number : 20101230-69-B-307-09(A)
Manufacturer Name : Esteve Quimica, SA
Manufacturer Address : Synthesis and purification process: Ctra. del Vendrell a St. Jaume dels Domenys, km. 5, 43711 Banyeres del Penedès (Tarragona), Spain Micronization and packaging process: C/Ter, 94. Polígon Industrial, 17460 Celrà (Girona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14786
Submission : 2000-03-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26811
Submission : 2013-01-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13255
Submission : 1998-10-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-105 - Rev 01
Issue Date : 2007-10-23
Type : Chemical
Substance Number : 1013
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21664
Submission : 2008-05-20
Status : Inactive
Type : II
Certificate Number : R0-CEP 2006-099 - Rev 00
Issue Date : 2007-12-19
Type : Chemical
Substance Number : 1013
Status : Expired
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