01 1Amoli Organics
02 1BASF
03 1Bajaj Healthcare
04 1CSPC Pharmaceutical Group
05 1DMFs Not Supported
06 1India Phosphate
07 1Reckon Organics
08 1Royal DSM
09 1Shandong Tianli Pharmaceutical Co ltd
10 1Shreenath Chemicals
11 1Zhejiang NHU Co
01 3China
02 1Germany
03 5India
04 1Netherlands
05 1Blank
01 3Active
02 2Inactive
03 6Blank
01 2Valid
02 9Blank
01 11Blank
01 1WC-0077
02 10Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-29
Pay. Date : 2018-03-22
DMF Number : 23686
Submission : 2010-04-03
Status : Active
Type : II
Certificate Number : CEP 2012-262 - Rev 03
Issue Date : 2024-02-22
Type : Chemical
Substance Number : 1791
Status : Valid
NDC Package Code : 72783-1002
Start Marketing Date : 2020-04-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38718
Submission : 2023-12-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-19
Pay. Date : 2017-01-10
DMF Number : 31184
Submission : 2016-12-21
Status : Active
Type : II
Certificate Number : R1-CEP 2002-254 - Rev 04
Issue Date : 2021-12-17
Type : Chemical
Substance Number : 1791
Status : Valid
NDC Package Code : 63238-3050
Start Marketing Date : 2017-12-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 4354
Submission : 1981-11-25
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 : 4743
Submission : 1982-11-18
Status : Inactive
Type : II
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