Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1ChemWerth Inc
03 1Veranova
04 1HRV Global Life Sciences
05 1ALP Pharm
06 2DEAFARMA
07 1Hospira, Inc.
08 1MSN Laboratories
09 1Nanjing Pharmaceutical
01 2China
02 2India
03 2Italy
04 1Spain
05 3U.S.A
01 6Active
02 1Inactive
03 3Blank
01 10Blank
01 10Blank
01 10Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-02
Pay. Date : 2022-03-17
DMF Number : 36436
Submission : 2022-06-14
Status : Active
Type : II
NDC Package Code : 64567-0023
Start Marketing Date : 2021-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, CN |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 34556
Submission : 2020-06-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16771
Submission : 2003-08-15
Status : Active
Type : II
NDC Package Code : 50137-2930
Start Marketing Date : 2008-08-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-25
Pay. Date : 2018-05-25
DMF Number : 29850
Submission : 2016-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37767
Submission : 2022-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34634
Submission : 2020-02-28
Status : Active
Type : II
NDC Package Code : 14501-0080
Start Marketing Date : 2014-04-23
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 : 11365
Submission : 1995-02-23
Status : Inactive
Type : II
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