Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1Jai Radhe Sales
03 1Moehs Iberica
04 1Shandong Chenghui Shuangda Pharmaceutical
05 1Asence Pharma
06 1Biotechnica DWC
07 1CARBOGEN AMCIS AG
08 1Cambrex Corporation
09 1Cerata Pharmaceuticals
10 2Dishman Carbogen Amcis
11 1Fareva
12 1Fresenius Kabi AB Brunna
13 1Green Stone Swiss Co ., Ltd
14 1Guangzhou Tosun Pharmaceutical
15 1Harman Finochem
16 1Ishita API
17 1Medigraph Pharmaceuticals Pvt. Ltd.
18 1Nanjing Bold Chemical
19 1Remedy Labs
20 1SIMS Srl
21 1Shree HariKrishna Pharmaceuticals
22 1Siegfried AG
23 1Surajlok Chemicals
24 1Swati Spentose
25 1Xian Libang Pharmaceutical Co.,Ltd
01 1Algeria
02 1Brazil
03 5China
04 12India
05 1Italy
06 1Luxembourg
07 1Spain
08 1Sweden
09 2Switzerland
10 1U.S.A
01 6Active
02 1Inactive
03 19Blank
01 6Valid
02 1Withdrawn by Holder
03 19Blank
01 1218MF10875
02 25Blank
01 1SD240040
02 1WC-0108
03 1WC-0135
04 1WC-0135A
05 1WC-0341
06 1WC-0435
07 20Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-29
Pay. Date : 2013-01-07
DMF Number : 22228
Submission : 2008-11-24
Status : Active
Type : II
Certificate Number : R1-CEP 2010-277 - Rev 03
Issue Date : 2022-01-24
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 52932-0729
Start Marketing Date : 2009-09-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
Date of Issue : 2024-08-02
Valid Till : 2027-08-01
Written Confirmation Number : SD240040
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6495
Submission : 1986-05-23
Status : Active
Type : II
Certificate Number : R1-CEP 2001-013 - Rev 02
Issue Date : 2015-02-09
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 12660-0391
Start Marketing Date : 1979-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 2911
Submission : 1977-04-12
Status : Active
Type : II
Certificate Number : R1-CEP 2004-043 - Rev 04
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 17381-074
Start Marketing Date : 2010-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-01
Pay. Date : 2014-04-25
DMF Number : 20959
Submission : 2007-10-18
Status : Active
Type : II
Date of Issue : 2019-12-03
Valid Till : 2022-07-21
Written Confirmation Number : WC-0135A
Address of the Firm :
NDC Package Code : 61876-0726
Start Marketing Date : 2016-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-31
Pay. Date : 2016-05-04
DMF Number : 21196
Submission : 2007-12-20
Status : Active
Type : II
Certificate Number : CEP 2003-173 - Rev 04
Issue Date : 2023-10-04
Type : Chemical
Substance Number : 541
Status : Valid
NDC Package Code : 46014-1113
Start Marketing Date : 2007-12-11
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 : 26649
Submission : 2012-12-28
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-116 - Rev 02
Issue Date : 2020-09-25
Type : Chemical
Substance Number : 541
Status : Valid
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0341
Address of the Firm :
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