Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1Bioquim
03 1ACS DOBFAR SPA
04 1Aurobindo Pharma Limited
05 1Fresenius Kabi AB Brunna
06 1Otto Brandes
07 1Qilu Pharmaceutical
08 2Qilu Tianhe Pharmaceutical Co., Ltd.
09 1Rajasthan Antibiotics
10 1Sandoz B2B
11 2Sterile India Pvt. Ltd
12 1Tecoland Corporation
01 3China
02 1Germany
03 4India
04 1Italy
05 1Netherlands
06 1Spain
07 1Sweden
08 1Switzerland
09 1U.S.A
01 7Active
02 7Blank
01 14Blank
01 14Blank
01 1WC-0121
02 1WC-0378
03 1WC-0378A2
04 1WC-0420-A
05 10Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-31
Pay. Date : 2013-12-17
DMF Number : 25545
Submission : 2011-11-29
Status : Active
Type : II
NDC Package Code : 66558-0209
Start Marketing Date : 2022-04-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (7.65kg/9kg .37kg/9kg .98kg/9kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Registrant Name : Sangjin Corporation
Registration Date : 2022-01-20
Registration Number : 20220120-210-J-1216
Manufacturer Name : Fresenius Kabi IPSUM SRL@[Piperacillin Hydrate Manufacturer]Fresenius Kabi IPSUM SRL@[Tazobactam Manufacturer]JiangXi Fushine Pharmaceutical Co., Ltd.
Manufacturer Address : Via San Leonardo, 23 – 45010 VILLADOSE (RO), Italy@[Piperacillin Hydrate Manufacture]Via San Leonardo, 23 – 45010 VILLADOSE (RO), Italy@[Tazobactam Manufacture]No.2 Yuli Industrial Zone, Changjiang District, Jingdezhen City, Jiangxi Province, China.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29994
Submission : 2016-11-28
Status : Active
Type : II
Date of Issue : 2020-04-16
Valid Till : 2022-07-06
Written Confirmation Number : WC-0378A2
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-07
Pay. Date : 2013-01-09
DMF Number : 26009
Submission : 2012-03-21
Status : Active
Type : II
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2018-06-20
Registration Number : 20180620-210-J-235
Manufacturer Name : Shandong Anxin Pharmaceutical Co., Ltd. (formerly Qilu Tianhe Pharmaceutical. Co. Ltd)@[Piperacillin Sodium Manufacturer]Shandong Anshun Pharmaceutical Co., Ltd@[Tazobactam Sodium Manufacturer]Shandong Anshun Pharmaceutical Co., Ltd
Manufacturer Address : No. 849 Dongjia Town Licheng district, Jinan City, Shandong Province, 250105 PR China @Circular Economy Demonstration Park, Laoling County, Dezhou City, Shandong Province, PR China@Circular Economy Demonstration Park, Laoling County, Dezhou City, Shandong Province, PR China
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-14
Pay. Date : 2019-02-20
DMF Number : 33540
Submission : 2019-02-21
Status : Active
Type : II
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2018-06-20
Registration Number : 20180620-210-J-235
Manufacturer Name : Shandong Anxin Pharmaceutical Co., Ltd. (formerly Qilu Tianhe Pharmaceutical. Co. Ltd)@[Piperacillin Sodium Manufacturer]Shandong Anshun Pharmaceutical Co., Ltd@[Tazobactam Sodium Manufacturer]Shandong Anshun Pharmaceutical Co., Ltd
Manufacturer Address : No. 849 Dongjia Town Licheng district, Jinan City, Shandong Province, 250105 PR China @Circular Economy Demonstration Park, Laoling County, Dezhou City, Shandong Province, PR China@Circular Economy Demonstration Park, Laoling County, Dezhou City, Shandong Province, PR China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18903
Submission : 2005-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20432
Submission : 2007-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36317
Submission : 2022-10-13
Status : Active
Type : II
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0121
Address of the Firm :
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