HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1Medichem S.A
03 1Alembic Pharmaceuticals Limited
04 1Arene Lifesciences
05 1Aurobindo Pharma Limited
06 1Changzhou Ruiming Pharmaceutical
07 1Cipla
08 1Emcure Pharmaceuticals
09 1Esteve Quimica
10 1Everlight Chemical
11 1HEC Pharm
12 1Hainan Poly Pharm
13 1Jiangsu Lianhuan Pharmaceutical
14 1Korea United Pharm. Inc.
15 1Nantong Chem-land
16 1Orchid Pharma
17 1Tecoland Corporation
18 1Wockhardt
19 1Yangzhou Pharmaceutical
20 1Yangzhou Pharmaceutical Factory
21 1Zhejiang Supor Pharmaceuticals Co., LTD
01 8China
02 8India
03 1South Korea
04 2Spain
05 1Taiwan
06 1U.S.A
01 7Active
02 9Inactive
03 5Blank
01 1Expired
02 7Valid
03 1Withdrawn by Holder
04 12Blank
01 1219MF10301
02 20Blank
01 1WC-0023
02 1WC-0082
03 1WC-0113
04 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 : Reviewed
Rev. Date : 2015-10-05
Pay. Date : 2015-09-24
DMF Number : 17030
Submission : 2003-12-10
Status : Active
Type : II
Certificate Number : R1-CEP 2004-257 - Rev 02
Issue Date : 2023-04-04
Type : Chemical
Substance Number : 1013
Status : Valid
Registration Number : 219MF10301
Registrant's Address : 6Floor, Chung Ting Building No. 77, Section 2, Tun Hua South Road, Taipei, Taiwan
Initial Date of Registration : 2007-09-18
Latest Date of Registration : --
NDC Package Code : 65035-105
Start Marketing Date : 2016-08-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1000g/1000g)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2020-03-18
Registration Number : 20050831-69-B-179-02(6)
Manufacturer Name : Everlight Chemical Industrial Corporation
Manufacturer Address : 12, Industrial Third Rd., Kuanyin Industrial District, Kuanyin Hsiang, Taoyuan Hsien, Taiwan
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 : 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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