Inke S.A: APIs manufacturing plant.
01 2Inke S.A
02 1Beijing Breathgreen Healthcare
03 2Cipla
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 10India
03 2Spain
01 5Active
02 10Blank
01 15Blank
01 15Blank
01 1WC-0021
02 1WC-0021n
03 1WC-0144
04 1WC-0144A5
05 1WC-0227
06 10Blank
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 : 2018-10-24
Pay. Date : 2018-07-26
DMF Number : 28013
Submission : 2014-03-15
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0077
Start Marketing Date : 2012-07-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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-0144
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
Date of Issue : 2022-07-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-0227
Address of the Firm :
Date of Issue : 2020-01-28
Valid Till : 2022-09-08
Written Confirmation Number : WC-0144A5
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
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021
Address of the Firm :
NDC Package Code : 14501-0077
Start Marketing Date : 2012-07-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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