Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
01 1Apex Healthcare Limited
02 1Anmol Chemicals
03 1Laboratorios Químicos
04 1Muby Chem
05 1Nanochemazone
06 1Roussel Delma Pharmaceuticals
01 1Argentina
02 1Canada
03 3India
04 1U.S.A
01 2Active
02 4Blank
01 6Blank
01 6Blank
01 1WC-0518
02 5Blank
01 6Blank
01 167614-0034
02 169617-015
03 4Blank
01 6Blank
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
NDC Package Code : 69617-015
Start Marketing Date : 2025-09-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39868
Submission : 2024-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37188
Submission : 2022-06-17
Status : Active
Type : IV
Date of Issue : 2025-01-17
Valid Till : 2028-02-02
Written Confirmation Number : WC-0518
Address of the Firm :
NDC Package Code : 67614-0034
Start Marketing Date : 2024-01-22
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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