01 1Agno Pharma
02 2Aurore Life Sciences
03 1F.I.S. Fabbrica Italiana Sintetici
04 1Flamma SpA
05 1JIANGSU ZW PHARMACEUTICALS CO LTD
06 1Nippon Kayaku
07 1Olon S.p.A
08 1Piramal Pharma Solutions
09 1Sifavitor srl
10 1Sinbiotik
11 1TAAJ Healthcare
12 4Blank
01 1China
02 3India
03 4Italy
04 1Japan
05 1Mexico
06 2U.S.A
07 4Blank
01 5Active
02 7Inactive
03 4Blank
01 16Blank
01 1220MF10202
02 15Blank
01 1WC-0119
02 1WC-0119A10
03 1WC-0123
04 13Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-27
Pay. Date : 2017-10-04
DMF Number : 6187
Submission : 1986-02-11
Status : Active
Type : II
Registration Number : 220MF10202
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2008-09-19
Latest Date of Registration : --
NDC Package Code : 52133-0007
Start Marketing Date : 1982-01-01
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 : 26004
Submission : 2012-04-20
Status : Active
Type : II
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36760
Submission : 2022-02-03
Status : Active
Type : II
Date of Issue : 2022-09-19
Valid Till : 2025-07-02
Written Confirmation Number : WC-0119
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12224
Submission : 1996-11-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21102
Submission : 2007-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20104
Submission : 2006-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20742
Submission : 2007-07-30
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 : 6439
Submission : 1986-06-23
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 7005
Submission : 1987-05-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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 : 8472
Submission : 1990-03-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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