Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1HRV Global Life Sciences
03 1TAPI Technology & API Services
04 1ACS DOBFAR SPA
05 1Akums Lifesciences
06 1Asia Pioneer Pharmaceuticals
07 1Aurobindo Pharma Limited
08 1China Union Chempharma (Suzhou) Co.,Ltd
09 1Covalent Laboratories Private Limited
10 1Freemen Nutra
11 1Guangzhou Baiyunshan Chem.Pharm.Factory
12 1Guangzhou Tosun Pharmaceutical
13 1Hengdian Group
14 1Hetero Drugs
15 1Lupin Ltd
16 1Nishchem International Pvt. Ltd
17 2Orchid Pharma
18 1Orchidia Pharmaceutical Ind.
19 2Qilu Antibiotics Pharmaceutical Co., Ltd.
20 1Qilu Pharmaceutical
21 1RANBAXY LABORATORIES LIMITED
22 1Sandoz B2B
23 1Unimark Remedies Limited
24 1Virchow Group
25 1Zhejiang Dongying Pharmaceutical
01 9China
02 1Egypt
03 12India
04 1Israel
05 1Italy
06 1Netherlands
07 1Switzerland
08 1U.S.A
01 7Active
02 6Inactive
03 14Blank
01 5Valid
02 22Blank
01 27Blank
01 1WC-0120
02 1WC-0131
03 1WC-0202
04 1WC0131
05 23Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17827
Submission : 2004-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17731
Submission : 2004-09-29
Status : Active
Type : II
Date of Issue : 2019-07-05
Valid Till : 2022-07-04
Written Confirmation Number : WC-0202
Address of the Firm :
NDC Package Code : 57297-400
Start Marketing Date : 2016-02-25
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 : 17375
Submission : 2004-05-13
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-24
Pay. Date : 2014-03-24
DMF Number : 18469
Submission : 2005-06-28
Status : Active
Type : II
Certificate Number : CEP 2013-092 - Rev 01
Issue Date : 2023-12-13
Type : Chemical
Substance Number : 2342
Status : Valid
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0120
Address of the Firm :
NDC Package Code : 65862-378
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-07-11
Pay. Date : 2017-05-31
DMF Number : 29383
Submission : 2015-05-15
Status : Active
Type : II
NDC Package Code : 61788-4000
Start Marketing Date : 2008-12-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2020-11-25
Registration Number : 20201125-209-J-791
Manufacturer Name : Covalent Laboratories Private Limited
Manufacturer Address : Survey No. 374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District Telangana State India 502 296
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24047
Submission : 2010-08-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-10
Pay. Date : 2012-12-19
DMF Number : 26699
Submission : 2013-01-09
Status : Active
Type : II
Certificate Number : R0-CEP 2020-252 - Rev 00
Issue Date : 2021-02-19
Type : Chemical
Substance Number : 2342
Status : Valid
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2022-03-17
Registration Number : 20180903-209-J-8(3)
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21471
Submission : 2008-03-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18434
Submission : 2005-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18901
Submission : 2005-10-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17453
Submission : 2004-06-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26354
Submission : 2012-08-22
Status : Inactive
Type : II
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2019-05-02
Registration Number : 20181101-209-J-49(2)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 VIMERCATE (MB), Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16973
Submission : 2003-11-21
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-488 - Rev 00
Issue Date : 2023-08-01
Type : Chemical
Substance Number : 2342
Status : Valid
Date of Issue : 2019-07-22
Valid Till : 2022-07-20
Written Confirmation Number : WC0131
Address of the Firm :
Certificate Number : R0-CEP 2020-171 - Rev 00
Issue Date : 2021-11-04
Type : Chemical
Substance Number : 2342
Status : Valid
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-209-J-707
Manufacturer Name : Zhejiang Dongying Pharmaceutical Co., Ltd.
Manufacturer Address : Weiwu Road, Hangzhou Bay Shangyu Economic and Technological Development Area China
Certificate Number : CEP 2013-093 - Rev 02
Issue Date : 2024-12-11
Type : Chemical
Substance Number : 2342
Status : Valid
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2022-03-17
Registration Number : 20180903-209-J-8(3)
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd.
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China
A Cefprozil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefprozil, including repackagers and relabelers. The FDA regulates Cefprozil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefprozil 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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A Cefprozil supplier is an individual or a company that provides Cefprozil active pharmaceutical ingredient (API) or Cefprozil finished formulations upon request. The Cefprozil suppliers may include Cefprozil API manufacturers, exporters, distributors and traders.
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