01 1Actylis
02 1Calyx Chemicals & Pharmaceuticals Limited
03 1F. Hoffmann-La Roche
04 1Gurvey & Berry
05 1Keshava Organics
06 1Laurus Labs
07 1Maithili Life Sciences
08 1Maithri Drugs
09 1Nantong Chem-land
10 1Nantong Jinghua Pharmaceutical
11 1Royal DSM
12 1Solara Active Pharma Sciences
13 2Tianish Laboratories
14 1Viatris
01 1Canada
02 2China
03 8India
04 1Netherlands
05 1Switzerland
06 2U.S.A
01 6Active
02 2Inactive
03 7Blank
01 6Valid
02 9Blank
01 1222MF10042
02 14Blank
01 1WC-0213
02 1WC-0455
03 13Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23503
Submission : 2010-01-22
Status : Active
Type : II
Certificate Number : R1-CEP 2016-019 - Rev 00
Issue Date : 2023-07-05
Type : Chemical
Substance Number : 766
Status : Valid
NDC Package Code : 66639-008
Start Marketing Date : 2009-06-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-28
Pay. Date : 2014-06-15
DMF Number : 28247
Submission : 2014-06-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-09-13
Pay. Date : 2018-07-20
DMF Number : 32090
Submission : 2017-11-10
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-05
Pay. Date : 2015-02-04
DMF Number : 25094
Submission : 2011-07-14
Status : Active
Type : II
Certificate Number : R1-CEP 2016-161 - Rev 00
Issue Date : 2023-07-03
Type : Chemical
Substance Number : 766
Status : Valid
NDC Package Code : 59348-0016
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 : Reviewed
Rev. Date : 2022-08-24
Pay. Date : 2022-07-13
DMF Number : 31959
Submission : 2017-08-30
Status : Active
Type : II
Date of Issue : 2022-11-18
Valid Till : 2025-09-30
Written Confirmation Number : WC-0455
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-05
Pay. Date : 2022-11-09
DMF Number : 37631
Submission : 2022-11-30
Status : Active
Type : II
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9259
Submission : 1991-07-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15476
Submission : 2001-06-07
Status : Inactive
Type : II
Certificate Number : CEP 2020-423 - Rev 01
Issue Date : 2024-07-25
Type : Chemical
Substance Number : 766
Status : Valid
Certificate Number : R1-CEP 2009-091 - Rev 01
Issue Date : 2022-01-11
Type : Chemical
Substance Number : 766
Status : Valid
Registration Number : 222MF10042
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2010-02-04
Latest Date of Registration : --
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