Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
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02 1Jai Radhe Sales
03 1Moehs Iberica
04 1Shandong Chenghui Shuangda Pharmaceutical
05 1Tenatra Exports
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07 1Abhilasha Pharma
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01 1218MF10875
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01 1SD240040
02 1WC-0108
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01 120221215-210-J-1423
02 120250124-210-J-1727
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01 110695-038
02 112651-111
03 112660-0391
04 117381-074
05 138779-0524
06 146014-1113
07 149452-1313
08 151552-0456
09 151927-0232
10 151927-0244
11 151927-2358
12 152932-0729
13 161876-0726
14 162991-2014
15 166064-1031
16 169617-012
17 171277-0126
18 173377-239
19 182393-208
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Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
NDC Package Code : 69617-012
Start Marketing Date : 2024-12-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Date of Issue : 2024-08-02
Valid Till : 2027-08-01
Written Confirmation Number : SD240040
Address of the Firm :
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 2025-12-31
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26649
Submission : 2012-12-28
Status : Inactive
Type : II
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