Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 1Omgene Life Sciences Pvt. Ltd
02 1Alembic Pharmaceuticals Limited
03 1Hetero Drugs
04 1Icrom
05 1MSN Laboratories
06 1Blank
01 4India
02 1Italy
03 1Blank
01 3Active
02 3Blank
01 6Blank
01 6Blank
01 1WC-0349
02 5Blank
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-13
Pay. Date : 2022-04-19
DMF Number : 36600
Submission : 2021-12-30
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40805
Submission : 2024-11-27
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-15
Pay. Date : 2022-01-06
DMF Number : 36434
Submission : 2021-12-09
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0119
Start Marketing Date : 2021-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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