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01 1Jai Radhe Sales
02 1Nortec Quimica
03 1Harika Drugs
04 13M Company
05 1Albemarle Corporation
06 1Grace
07 1Kores India Limited
08 1Nishchem International Pvt. Ltd
09 2ORGAMOL PHARMA SOLUTIONS SA
10 2Procos
11 2R L Fine Chem
12 1Tecoland Corporation
13 1Blank
01 1Brazil
02 6India
03 2Italy
04 2Switzerland
05 4U.S.A
06 1Blank
01 4Active
02 5Inactive
03 7Blank
01 1Valid
02 15Blank
01 16Blank
01 1WC-0139
02 1WC-0445
03 14Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-13
Pay. Date : 2014-10-31
DMF Number : 14971
Submission : 2000-07-19
Status : Active
Type : II
NDC Package Code : 46016-0140
Start Marketing Date : 2003-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33901
Submission : 2019-05-29
Status : Active
Type : II
Certificate Number : CEP 2022-094 - Rev 00
Issue Date : 2024-05-21
Type : Chemical
Substance Number : 1759
Status : Valid
Date of Issue : 2019-07-29
Valid Till : 2022-07-29
Written Confirmation Number : WC-0445
Address of the Firm :
NDC Package Code : 71554-012
Start Marketing Date : 2019-04-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20201013-209-J-733
Manufacturer Name : RL Fine Chem Pvt Ltd
Manufacturer Address : Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Gowribidanur, Chikkaballapur Dist., Karnataka-561 208, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38456
Submission : 2023-06-05
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-22
Written Confirmation Number : WC-0139
Address of the Firm :
NDC Package Code : 71554-012
Start Marketing Date : 2019-04-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20201013-209-J-733
Manufacturer Name : RL Fine Chem Pvt Ltd
Manufacturer Address : Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Gowribidanur, Chikkaballapur Dist., Karnataka-561 208, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-16
Pay. Date : 2013-07-05
DMF Number : 5722
Submission : 1985-02-22
Status : Active
Type : II
NDC Package Code : 22568-1022
Start Marketing Date : 2021-06-01
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 : 4457
Submission : 1982-02-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4811
Submission : 1983-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2942
Submission : 1977-05-09
Status : Inactive
Type : II
NDC Package Code : 46016-0140
Start Marketing Date : 2003-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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