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01 1Jai Radhe Sales
02 1Acharya Chemicals
03 1Alembic Pharmaceuticals Limited
04 2Cambrex Corporation
05 1Centaur Pharmaceuticals
06 1F. Hoffmann-La Roche
07 2F.I.S. Fabbrica Italiana Sintetici
08 1Fred Hutchinson Cancer Center
09 1Lake Chemicals
10 2R L Fine Chem
11 1Raks Pharma
12 1SIMS Srl
01 8India
02 3Italy
03 1Switzerland
04 3U.S.A
01 5Active
02 3Inactive
03 7Blank
01 4Valid
02 11Blank
01 1218MF10145
02 1222MF10163
03 13Blank
01 1WC-0082
02 1WC-0101
03 1WC-0107
04 1WC-0445A2
05 1WC-0445A3
06 10Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-14
Pay. Date : 2013-09-20
DMF Number : 25335
Submission : 2011-09-29
Status : Active
Type : II
Certificate Number : CEP 2009-276 - Rev 02
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 656
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-06-25
Written Confirmation Number : WC-0107
Address of the Firm :
NDC Package Code : 64330-082
Start Marketing Date : 2015-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33972
Submission : 2019-06-26
Status : Active
Type : II
Date of Issue : 2020-03-31
Valid Till : 2022-07-28
Written Confirmation Number : WC-0445A3
Address of the Firm :
NDC Package Code : 71554-014
Start Marketing Date : 2019-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-16
Pay. Date : 2017-10-26
DMF Number : 467
Submission : 1962-02-15
Status : Active
Type : II
Certificate Number : R1-CEP 2001-423 - Rev 02
Issue Date : 2014-02-24
Type : Chemical
Substance Number : 656
Status : Valid
Registration Number : 222MF10163
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2010-06-02
Latest Date of Registration : --
NDC Package Code : 48087-0129
Start Marketing Date : 2010-04-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-05-04
Registration Number : 20210504-209-J-978
Manufacturer Name : FIS Fabbrica Italiana Sintetici SpA
Manufacturer Address : Viale Milano, 26-36075 MONTECCHIO MAGGIORE (VI), Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2200
Submission : 1973-12-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 646
Submission : 1963-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22214
Submission : 2008-11-21
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-103 - Rev 00
Issue Date : 2022-04-20
Type : Chemical
Substance Number : 474
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
Date of Issue : 2020-03-31
Valid Till : 2022-07-28
Written Confirmation Number : WC-0445A2
Address of the Firm :
NDC Package Code : 71554-014
Start Marketing Date : 2019-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2001-417 - Rev 03
Issue Date : 2016-10-28
Type : Chemical
Substance Number : 474
Status : Valid
NDC Package Code : 48087-0129
Start Marketing Date : 2010-04-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2021-05-04
Registration Number : 20210504-209-J-978
Manufacturer Name : FIS Fabbrica Italiana Sintetici SpA
Manufacturer Address : Viale Milano, 26-36075 MONTECCHIO MAGGIORE (VI), Italy
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