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01 1Jai Radhe Sales
02 1Beijing Fukangren Biopharmaceutical
03 1Celanese
04 1DK Pharmachem Pvt. Ltd
05 1Daito Pharmaceutical
06 1GSK
07 1KIVIPharm
08 1Katsura Chemical
09 1Kyowa Hakko Bio
10 1Kyowa Pharma Chemical Co Ltd
11 1Recordati
12 1Siegfried AG
13 1Synthetic Molecules Private Limited
14 1Zambon Switzerland
15 1Blank
01 2China
02 3India
03 1Italy
04 4Japan
05 2Switzerland
06 1U.S.A
07 1United Kingdom
08 1Blank
01 2Active
02 5Inactive
03 8Blank
01 2Valid
02 13Blank
01 1218MF10519
02 1218MF10897
03 1218MF10917
04 1222MF10235
05 1304MF10111
06 10Blank
01 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3116
Submission : 1977-12-27
Status : Active
Type : II
Certificate Number : R1-CEP 2007-049 - Rev 01
Issue Date : 2015-12-15
Type : Chemical
Substance Number : 664
Status : Valid
Registration Number : 218MF10519
Registrant's Address : Karlstrasse 15, 32423, Minden, Federal Republic of Germany
Initial Date of Registration : 2006-05-18
Latest Date of Registration : --
NDC Package Code : 65724-4500
Start Marketing Date : 2009-06-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-30
Pay. Date : 2014-05-30
DMF Number : 5134
Submission : 1983-06-10
Status : Active
Type : II
Registration Number : 304MF10111
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2022-08-03
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4415
Submission : 1982-01-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3060
Submission : 1977-11-22
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3165
Submission : 1978-02-22
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5788
Submission : 1985-03-29
Status : Inactive
Type : II
Certificate Number : R0-CEP 2020-355 - Rev 00
Issue Date : 2023-04-05
Type : Chemical
Substance Number : 664
Status : Valid
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