Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1TAPI Technology & API Services
03 2ACS DOBFAR SPA
04 1Aurobindo Pharma Limited
05 1Bristol Myers Squibb
06 1China Union Chempharma (Suzhou) Co.,Ltd
07 3Eli Lilly
08 1Grand Health Industrial Co Ltd
09 1Hengdian Group
10 1Kyongbo Pharmaceutical Co., Ltd
11 2Lupin Ltd
12 1Nishchem International Pvt. Ltd
13 2Qilu Antibiotics Pharmaceutical Co., Ltd.
14 1RANBAXY LABORATORIES LIMITED
15 1SURYA PHARMACEUTICAL LTD.
16 1Sun Pharmaceutical Industries Limited
17 1Suvan Lifesciences
18 1Unimark Remedies Limited
19 1Yuhan Corporation
20 1Zhejiang East Asia Pharmaceutical
21 3Blank
01 6China
02 9India
03 1Israel
04 2Italy
05 1Netherlands
06 2South Korea
07 4U.S.A
08 3Blank
01 2Active
02 12Inactive
03 14Blank
01 1Suspended by Holder
02 7Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 1Withdrawn by Holder
05 18Blank
01 1218MF10591
02 1227MF10171
03 1230MF10134
04 25Blank
01 1WC-0202
02 1WC-0342
03 26Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2017-04-11
Registration Number : 20170411-20-A-326-20
Manufacturer Name : Centrient Pharmaceuticals (Zibo) Co., Ltd.
Manufacturer Address : West of Baoshan Road, North of Beiling Road, High-Tech Zone, Zibo Shandong Province, China
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 : 14605
Submission : 1999-11-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12086
Submission : 1996-08-02
Status : Active
Type : II
Certificate Number : R1-CEP 2001-359 - Rev 05
Issue Date : 2018-06-12
Type : Chemical
Substance Number : 986
Status : Valid
Date of Issue : 2019-07-05
Valid Till : 2022-07-04
Written Confirmation Number : WC-0202
Address of the Firm :
Registrant Name : Big Farms Co., Ltd.
Registration Date : 2019-08-29
Registration Number : 20050831-20-A-21-05(22)
Manufacturer Name : Lupin Ltd.
Manufacturer Address : Unit-1, 198-202, New Industrial area No.2 Dist. - Raisen Mandideep Madhya Pradesh 462046, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13780
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1996-008 - Rev 04
Issue Date : 2020-12-17
Type : Chemical
Substance Number : 986
Status : Valid
Registration Number : 218MF10591
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2006-06-22
Latest Date of Registration : --
NDC Package Code : 52946-0912
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2020-05-11
Registration Number : 20050831-20-A-17-02(20)
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 : 13217
Submission : 1998-04-30
Status : Inactive
Type : II
Registrant Name : Big Farms Co., Ltd.
Registration Date : 2019-08-29
Registration Number : 20050831-20-A-21-05(22)
Manufacturer Name : Lupin Ltd.
Manufacturer Address : Unit-1, 198-202, New Industrial area No.2 Dist. - Raisen Mandideep Madhya Pradesh 462046, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13226
Submission : 1998-04-30
Status : Inactive
Type : II
Portfolio PDF
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Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14754
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13598
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13622
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13647
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19643
Submission : 2006-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20288
Submission : 2006-11-14
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-306 - Rev 01
Issue Date : 2015-12-03
Type : Chemical
Substance Number : 986
Status : Withdrawn by Holder
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-20-A-19-03
Manufacturer Name : Kyungbo Pharmaceutical Co., Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13218
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14211
Submission : 1997-04-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13790
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 1997-027 - Rev 08
Issue Date : 2015-05-06
Type : Chemical
Substance Number : 986
Status : Valid
Certificate Number : R1-CEP 2005-092 - Rev 01
Issue Date : 2011-10-17
Type : Chemical
Substance Number : 986
Status : Suspended by Holder
Date of Issue : 2015-08-25
Valid Till : 2018-08-25
Written Confirmation Number : WC-0342
Address of the Firm :
Certificate Number : R0-CEP 2018-052 - Rev 00
Issue Date : 2020-03-31
Type : Chemical
Substance Number : 986
Status : Valid
Registrant Name : Seongun Pharmacopia Co., Ltd.
Registration Date : 2024-03-22
Registration Number : 20240322-20-A-378-22
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, 250105, China
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2022-08-08
Registration Number : 20220808-20-A-373-21
Manufacturer Name : China Union Chempharma (Suzhou) Co., Ltd.
Manufacturer Address : No. 6 Jinzi Road Lili Town Wujiang Dist, Suzhou, 215211, China
Certificate Number : CEP 2023-429 - Rev 00
Issue Date : 2024-05-24
Type : Chemical
Substance Number : 986
Status : Valid
Registration Number : 227MF10171
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2015-06-18
Latest Date of Registration : --
NDC Package Code : 52946-0912
Start Marketing Date : 2009-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2020-05-11
Registration Number : 20050831-20-A-17-02(20)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy
Certificate Number : R0-CEP 2009-136 - Rev 00
Issue Date : 2012-08-21
Type : Chemical
Substance Number : 986
Status : Withdrawn by EDQM F...
Registration Number : 230MF10134
Registrant's Address : Pharm-Chem zone, Duqiao, Linhai, Taizhou, Zhejiang, China
Initial Date of Registration : 2018-09-14
Latest Date of Registration : --
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2022-222 - Rev 00
Issue Date : 2024-11-28
Type : Chemical
Substance Number : 986
Status : Valid
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R0-CEP 2022-030 - Rev 00
Issue Date : 2022-08-02
Type : Chemical
Substance Number : 986
Status : Valid
Registrant Name : Seongun Pharmacopia Co., Ltd.
Registration Date : 2024-03-22
Registration Number : 20240322-20-A-378-22
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, 250105, China
A Cefaclor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefaclor, including repackagers and relabelers. The FDA regulates Cefaclor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefaclor 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 Cefaclor supplier is an individual or a company that provides Cefaclor active pharmaceutical ingredient (API) or Cefaclor finished formulations upon request. The Cefaclor suppliers may include Cefaclor API manufacturers, exporters, distributors and traders.
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