01 1Apicore LLC
02 1Catalent Pharma Solutions
03 1Chongqing Huapont Pharmaceutical
04 1Emcure Pharmaceuticals
05 1Hetero Drugs
06 1Hunan Huateng Pharmaceutical Co ltd
07 1Jin Dun Medical
08 1MSN Laboratories
09 1Olon S.p.A
10 1Refarmed Chemicals
11 1Tianjin Weijie Pharmaceutical Co., Ltd.
12 1Viatris
01 4China
02 4India
03 1Italy
04 1Switzerland
05 2U.S.A
01 6Active
02 1Inactive
03 5Blank
01 12Blank
01 12Blank
01 1WC-0041
02 1WC-0226
03 1WC-0349
04 9Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31580
Submission : 2017-04-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-13
Pay. Date : 2016-03-29
DMF Number : 30077
Submission : 2016-01-13
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0035
Start Marketing Date : 2015-05-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-17
Pay. Date : 2016-02-19
DMF Number : 25542
Submission : 2011-11-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-02
Pay. Date : 2015-06-05
DMF Number : 28944
Submission : 2014-12-22
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0081
Start Marketing Date : 1999-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-27
Pay. Date : 2020-09-18
DMF Number : 31979
Submission : 2017-10-03
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-920
Start Marketing Date : 2022-03-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14086
Submission : 1999-04-19
Status : Inactive
Type : II
NDC Package Code : 69988-0006
Start Marketing Date : 2010-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
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