Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
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01 1Centrient Pharmaceuticals
02 5ACS DOBFAR SPA
03 1Aurobindo Pharma Limited
04 1Lupin Ltd
05 2Orchidia Pharmaceutical Ind.
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01 2Egypt
02 2India
03 5Italy
04 1Netherlands
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01 2Valid
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01 1WC-0048
02 1WC0131
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01 120050831-19-A-11-02
02 120050831-19-A-11-02(5)
03 120050831-19-A-11-02(7)
04 120050831-19-A-11-02(8)
05 120050831-19-A-11-02(9)
06 120050831-19-A-8-01
07 120050831-19-A-8-01(1)
08 120120106-19-A-256-09(3)
09 120180516-19-A-340-10
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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-22
Pay. Date : 2013-01-11
DMF Number : 13749
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2002-156 - Rev 06
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 813
Status : Valid
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-19-A-11-02
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy
Date of Issue : 2019-07-22
Valid Till : 2022-07-20
Written Confirmation Number : WC0131
Address of the Firm :
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2011-10-14
Registration Number : 20050831-19-A-8-01(1)
Manufacturer Name : Orchid Pharma Limited
Manufacturer Address : Plot Nos. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial Estate, Alathur, Chengalpattu District-603 110, India
Certificate Number : R1-CEP 1999-174 - Rev 04
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 813
Status : Valid
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2019-04-01
Registration Number : 20050831-19-A-11-02(9)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 7/9 20871 Vimercate (MB)-Italy
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2016-08-24
Registration Number : 20050831-19-A-11-02(8)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2011-10-07
Registration Number : 20050831-19-A-11-02(5)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 7/9 20871 Vimercate (MB)-Italy
Registrant Name : Korea Chorus Co., Ltd.
Registration Date : 2012-12-21
Registration Number : 20050831-19-A-11-02(7)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-05-16
Registration Number : 20180516-19-A-340-10
Manufacturer Name : Aurobindo Pharma Limited (Unit-XI)
Manufacturer Address : Sy.Nos.1/22, 2/1 to 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam Mandal, Srikakulam Dist., Andhra Pradesh, India
Date of Issue : 2019-08-01
Valid Till : 2022-07-31
Written Confirmation Number : WC-0048
Address of the Firm :
Registrant Name : Pampia Co., Ltd.
Registration Date : 2024-07-30
Registration Number : 20120106-19-A-256-09(3)
Manufacturer Name : Lupin Limited
Manufacturer Address : Plot No. 9,123,123/1, 124&125 GIDC Estate, Ankleshwar, 393 002, Bharuch Gujarat state, India
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-19-A-8-01
Manufacturer Name : Orchid Pharma Limited
Manufacturer Address : Plot Nos. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial Estate, Alathur, Chengalpattu District-603 110, India
91
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