Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 1Omgene Life Sciences Pvt. Ltd
02 1Apotex Pharmachem
03 1Aspire Lifesciences Pvt Ltd
04 1Dipharma
05 1Glenmark Life Sciences
06 1Glenmark Pharmaceuticals
07 1Hetero Drugs
08 1Indoco Remedies Limited
09 1Lupin Ltd
10 2MSN Laboratories
11 1Micro Labs Limited
12 1Vasista
13 1Zhejiang Jiuzhou Pharmaceutical
01 1Canada
02 1China
03 11India
04 1Italy
01 8Active
02 1Inactive
03 5Blank
01 14Blank
01 14Blank
01 1WC-0057n
02 1WC-0383
03 12Blank
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-21
Pay. Date : 2015-03-16
DMF Number : 29034
Submission : 2015-03-27
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-07
Pay. Date : 2021-07-13
DMF Number : 36077
Submission : 2021-08-18
Status : Active
Type : II
NDC Package Code : 65977-0068
Start Marketing Date : 2008-11-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-03
Pay. Date : 2023-04-12
DMF Number : 38182
Submission : 2023-03-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-07
Pay. Date : 2012-11-09
DMF Number : 25676
Submission : 2012-01-04
Status : Active
Type : II
NDC Package Code : 46438-0661
Start Marketing Date : 2021-04-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-03
Pay. Date : 2018-07-26
DMF Number : 26385
Submission : 2012-09-29
Status : Active
Type : II
Date of Issue : 2019-07-26
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383
Address of the Firm :
NDC Package Code : 14501-0058
Start Marketing Date : 2010-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-10
Pay. Date : 2018-07-16
DMF Number : 32713
Submission : 2018-04-30
Status : Active
Type : II
NDC Package Code : 14501-0058
Start Marketing Date : 2010-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28284
Submission : 2014-05-09
Status : Inactive
Type : II
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