Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1Shanghai Minbiotech
03 3Antibiotice SA
04 1BrightGene Bio-Medical Technology Co.,Ltd
05 4Bristol Myers Squibb
06 1Concord Biotech
07 1Guangzhou Tosun Pharmaceutical
08 1Olon S.p.A
09 1Pfizer Inc
10 1VUAB Pharma
11 1Zhejiang Huida Biotech
12 1Blank
01 4China
02 1Czech Republic
03 1India
04 1Italy
05 1Netherlands
06 3Romania
07 5U.S.A
08 1Blank
01 4Active
02 6Inactive
03 7Blank
01 4Valid
02 13Blank
01 17Blank
01 17Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-07
Pay. Date : 2013-07-29
DMF Number : 13523
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 1999-099 - Rev 09
Issue Date : 2024-03-22
Type : Chemical
Substance Number : 517
Status : Valid
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-21
DMF Number : 14813
Submission : 2000-03-31
Status : Active
Type : II
Certificate Number : R1-CEP 2003-096 - Rev 04
Issue Date : 2022-01-28
Type : Chemical
Substance Number : 517
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2014-01-09
DMF Number : 14056
Submission : 1999-04-05
Status : Active
Type : II
Certificate Number : R1-CEP 2003-118 - Rev 07
Issue Date : 2023-04-11
Type : Chemical
Substance Number : 517
Status : Valid
NDC Package Code : 53734-336
Start Marketing Date : 2017-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-28
Pay. Date : 2020-11-05
DMF Number : 35225
Submission : 2020-11-04
Status : Active
Type : II
Certificate Number : R0-CEP 2020-247 - Rev 00
Issue Date : 2022-10-12
Type : Chemical
Substance Number : 517
Status : Valid
NDC Package Code : 17337-0330
Start Marketing Date : 2024-02-15
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 : 15028
Submission : 2000-09-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 708
Submission : 1963-04-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1740
Submission : 1971-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13298
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13441
Submission : 1998-09-01
Status : Inactive
Type : II
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