01 1Amino Chemicals
02 1Aurobindo Pharma Limited
03 1DEAFARMA
04 1Hetero Drugs
05 1Quimica Sintetica
06 1RANBAXY LABORATORIES LIMITED
07 1Siegfried AG
08 1Zhejiang Huahai Pharmaceutical
01 1China
02 3India
03 1Italy
04 1Malta
05 1Spain
06 1Switzerland
01 3Active
02 3Inactive
03 2Blank
01 4Valid
02 4Blank
01 8Blank
01 1WC-0017
02 1WC-0040
03 6Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16008
Submission : 2002-06-11
Status : Active
Type : II
Certificate Number : CEP 2013-018 - Rev 02
Issue Date : 2023-11-29
Type : Chemical
Substance Number : 1751
Status : Valid
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0004
Start Marketing Date : 1991-05-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-06
Pay. Date : 2012-11-23
DMF Number : 17805
Submission : 2004-10-27
Status : Active
Type : II
Certificate Number : R1-CEP 2011-271 - Rev 01
Issue Date : 2022-01-11
Type : Chemical
Substance Number : 1751
Status : Valid
NDC Package Code : 64220-144
Start Marketing Date : 2008-06-30
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 : 19711
Submission : 2006-08-17
Status : Active
Type : II
Certificate Number : CEP 2010-030 - Rev 02
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 1751
Status : Valid
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-393
Start Marketing Date : 2023-12-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16321
Submission : 2002-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15326
Submission : 2001-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15934
Submission : 2002-04-11
Status : Inactive
Type : II
Certificate Number : CEP 2021-425 - Rev 00
Issue Date : 2024-06-21
Type : Chemical
Substance Number : 1751
Status : Valid
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