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01 1Fermion Oy
02 1HRV Global Life Sciences
03 1Alkaloida Chemical Company Zrt
04 1Apotex Pharmachem
05 1Archimica
06 1Aspire Lifesciences Pvt Ltd
07 1Cyclo Industries
08 1Emcure Pharmaceuticals
09 1Fareva
10 1Hiray Pharma Solutions
11 1Industriale Chimica
12 1Jiangsu Nhwa Pharmaceutical
13 1Maithri Drugs
14 1Medilux Laboratories
15 1R L Fine Chem
16 1Solara Active Pharma Sciences
17 1Southwest Synthetic Pharmaceutical
18 2Unichem Laboratories Limited
19 1Unimark Remedies Limited
20 1Zydus Lifesciences
21 3Blank
01 1Canada
02 3China
03 1Finland
04 1Hungary
05 11India
06 2Italy
07 1Luxembourg
08 1U.S.A
09 3Blank
01 8Active
02 9Inactive
03 7Blank
01 1Expired
02 3Valid
03 20Blank
01 24Blank
01 1WC-0062
02 1WC-0062A4
03 1WC-0170
04 21Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-07-21
DMF Number : 11148
Submission : 1994-10-21
Status : Active
Type : II
Certificate Number : R0-CEP 2021-262 - Rev 00
Issue Date : 2022-10-27
Type : Chemical
Substance Number : 1711
Status : Valid
NDC Package Code : 12780-2940
Start Marketing Date : 1994-10-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 9167
Submission : 1991-06-11
Status : Active
Type : II
NDC Package Code : 46014-1068
Start Marketing Date : 2012-08-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2018-10-11
Registration Number : 20181011-209-J-136
Manufacturer Name : Excella GmbH & Co. KG
Manufacturer Address : Nurnberger Str. 12, 90537 Feucht, Germany
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-09
Pay. Date : 2023-09-28
DMF Number : 35488
Submission : 2020-12-31
Status : Active
Type : II
Certificate Number : CEP 2021-174 - Rev 01
Issue Date : 2024-05-24
Type : Chemical
Substance Number : 1711
Status : Valid
NDC Package Code : 72643-036
Start Marketing Date : 2023-07-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2021-12-28
Registration Number : 20211228-209-J-1093
Manufacturer Name : Solara Active Pharma Sciences Limited
Manufacturer Address : 120 A&B, 120P & 121, Industrial Area Baikampady New Mangalore – 575 011, Karnataka, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-13
Pay. Date : 2014-01-20
DMF Number : 25361
Submission : 2011-11-16
Status : Active
Type : II
Certificate Number : R0-CEP 2012-361 - Rev 00
Issue Date : 2014-11-13
Type : Chemical
Substance Number : 1711
Status : Expired
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-09-16
DMF Number : 29704
Submission : 2015-09-29
Status : Active
Type : II
Certificate Number : CEP 2022-151 - Rev 01
Issue Date : 2024-11-05
Type : Chemical
Substance Number : 1711
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-21
Written Confirmation Number : WC-0062
Address of the Firm :
NDC Package Code : 53747-040
Start Marketing Date : 2015-09-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-06
Pay. Date : 2023-08-29
DMF Number : 38109
Submission : 2023-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10414
Submission : 1993-08-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15163
Submission : 2000-11-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6418
Submission : 1986-06-02
Status : Inactive
Type : II
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