Inke S.A: APIs manufacturing plant.
01 2Inke S.A
02 1Beijing Breathgreen Healthcare
03 1Cipla
04 1Enaltec Labs Private Limited
05 1Glenmark Life Sciences
06 1Glenmark Pharmaceuticals
07 1Globofarm International
08 1Harman Finochem
09 1Hunan Warrant Chiral Pharmaceutical
10 2MSN Laboratories
11 1Melody Healthcare Pvt Ltd
12 1Shouyuan Chemical
01 3China
02 9India
03 2Spain
01 5Active
02 9Blank
01 14Blank
01 14Blank
01 1WC-0021
02 1WC-0021n
03 1WC-0057n
04 1WC-0144nA2
05 1WC-0227n
06 9Blank
Inke S.A: APIs manufacturing plant.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-12
Pay. Date : 2018-07-17
DMF Number : 32990
Submission : 2018-07-25
Status : Active
Type : II
NDC Package Code : 64567-0020
Start Marketing Date : 2018-07-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-03-24
Registration Number : 20220324-211-J-1236
Manufacturer Name : INKE, SA
Manufacturer Address : C/ Argent 1, Area industrial del Llobregat 08755, Castellbisbal (Barcelona) Spain
| Available Reg Filing : CN |
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-14
Pay. Date : 2022-03-17
DMF Number : 36435
Submission : 2022-05-16
Status : Active
Type : II
NDC Package Code : 64567-0020
Start Marketing Date : 2018-07-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-03-24
Registration Number : 20220324-211-J-1236
Manufacturer Name : INKE, SA
Manufacturer Address : C/ Argent 1, Area industrial del Llobregat 08755, Castellbisbal (Barcelona) Spain
| Available Reg Filing : CN |
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-09
Pay. Date : 2015-03-27
DMF Number : 28868
Submission : 2015-03-27
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-909
Start Marketing Date : 2015-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-15
Pay. Date : 2014-05-02
DMF Number : 22968
Submission : 2009-08-19
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-09-08
Written Confirmation Number : WC-0144nA2
Address of the Firm :
NDC Package Code : 53104-7731
Start Marketing Date : 2017-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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