Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
01 1Farmhispania
02 1HRV Global Life Sciences
03 1Neuland Laboratories
04 1Omgene Life Sciences Pvt. Ltd
05 1Aurobindo Pharma Limited
06 1Hetero Drugs
07 1Lupin Ltd
08 1Maithri Drugs
09 1Teva API
10 1Viatris
01 7India
02 1Israel
03 1Spain
04 1U.S.A
01 6Active
02 4Blank
01 10Blank
01 10Blank
01 1WC-0037
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37341
Submission : 2022-08-02
Status : Active
Type : II
NDC Package Code : 17404-1031
Start Marketing Date : 2024-01-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-2022
Start Marketing Date : 2017-09-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33849
Submission : 2019-12-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-08
Pay. Date : 2020-12-30
DMF Number : 35381
Submission : 2020-12-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-14
Pay. Date : 2020-11-19
DMF Number : 35197
Submission : 2020-11-18
Status : Active
Type : II
NDC Package Code : 65977-0123
Start Marketing Date : 2017-04-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-12
Pay. Date : 2020-09-28
DMF Number : 35247
Submission : 2020-09-29
Status : Active
Type : II
NDC Package Code : 59651-496
Start Marketing Date : 2023-12-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35158
Submission : 2020-08-31
Status : Active
Type : II
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