Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1HRV Global Life Sciences
03 1Almirall
04 1Beijing Breathgreen Healthcare
05 1Deva Holding AS
06 1Guangzhou Tosun Pharmaceutical
07 1Harman Finochem
08 1Hovione
09 1Jayco Chemical Industries
10 1MSN Laboratories
11 1Olon S.p.A
12 1R L Fine Chem
13 1Zhejiang Ausun Pharmaceutical
01 3China
02 5India
03 1Italy
04 1Portugal
05 2Spain
06 1Turkey
01 3Active
02 1Inactive
03 9Blank
01 13Blank
01 1226MF10012
02 12Blank
01 1WC-0349
02 12Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-14
Pay. Date : 2023-04-21
DMF Number : 36437
Submission : 2023-03-16
Status : Active
Type : II
NDC Package Code : 64567-0028
Start Marketing Date : 2022-01-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16926
Submission : 2003-10-17
Status : Active
Type : II
Registration Number : 226MF10012
Registrant's Address : General Miter, 151, 08022 Barcelona, Spain
Initial Date of Registration : 2014-01-08
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28093
Submission : 2014-03-26
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 : 54893-0027
Start Marketing Date : 2014-03-26
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 : 34231
Submission : 2019-12-20
Status : Inactive
Type : II
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