GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36506
Submission : 2022-06-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28449
Submission : 2014-06-16
Status : Active
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-418 - Rev 00
Issue Date : 2025-03-26
Type : Chemical
Substance Number : 1444
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2006-085 - Rev 04
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
Status : Valid
NDC Package Code : 59044-0017
Start Marketing Date : 2018-06-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2009-392 - Rev 01
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Status : Valid
NDC Package Code : 59044-0007
Start Marketing Date : 2006-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (22.7kg/22.7kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59044-0027
Start Marketing Date : 2006-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (907kg/907kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2016-283 - Rev 01
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Status : Valid
Certificate Number : R1-CEP 2016-283 - Rev 01
Status : Valid
Issue Date : 2023-01-12
Type : Chemical
Substance Number : 1444
Certificate Number : R1-CEP 2009-392 - Rev 01
Status : Valid
Issue Date : 2022-07-06
Type : Chemical
Substance Number : 1444
Macrogols, Types 3350 And 4000
Certificate Number : CEP 2006-085 - Rev 04
Status : Valid
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 1444
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2024-418 - Rev 00
Status : Valid
Issue Date : 2025-03-26
Type : Chemical
Substance Number : 1444
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
MARKET PLACE