Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1ACS DOBFAR SPA
03 1Lupin Ltd
04 1Orchidia Pharmaceutical Ind.
01 1Egypt
02 1India
03 1Italy
04 1Netherlands
01 1Active
02 3Blank
01 2Valid
02 2Blank
01 4Blank
01 1WC-0048
02 1WC0131
03 2Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
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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
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
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
A Cefadroxil Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefadroxil Monohydrate, including repackagers and relabelers. The FDA regulates Cefadroxil Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefadroxil Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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