Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
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01 1Apex Healthcare Limited
02 1Jai Radhe Sales
03 1Moehs Iberica
04 1Shandong Chenghui Shuangda Pharmaceutical
05 1Tenatra Exports
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07 1Swati Spentose
08 1Abhilasha Pharma
09 1Asence Pharma
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01 6Active
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01 1218MF10875
02 39Blank
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01 1SD240040
02 1WC-0108
03 1WC-0341
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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.
SWATI – Transforming science into solutions with 50+ years of expertise, global accreditations, and pioneering biotech innovation.
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
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A Marcaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Marcaine, including repackagers and relabelers. The FDA regulates Marcaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Marcaine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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