Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.

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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.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
NDC Package Code : 10695-038
Start Marketing Date : 2017-04-18
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 : 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

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