01 1Fuan Pharmaceutical
02 1Guangzhou Tosun Pharmaceutical
03 1Jeil Pharmaceutical Co., Ltd
04 1Lunan Pharmaceutical
05 1Lupin Ltd
06 1Meiji Seika Pharma
07 1Nectar Lifesciences
08 1Nishchem International Pvt. Ltd
09 1Orchid Pharma
10 1Qilu Pharmaceutical
11 1RANBAXY LABORATORIES LIMITED
12 1Suvan Lifesciences
13 1Virchow Group
14 2YUNGJIN PHARM. CO. LTD
15 1ZHEJIANG HUAFANG PHARMACEUTICAL CO LTD
01 5China
02 7India
03 1Japan
04 3South Korea
01 2Active
02 3Inactive
03 11Blank
01 16Blank
01 1219MF10254
02 1228MF10040
03 1302MF10072
04 1306MF10127
05 12Blank
01 1WC-0131
02 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20292
Submission : 2007-02-22
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 25086
Submission : 2011-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17482
Submission : 2004-06-22
Status : Inactive
Type : II
Registration Number : 302MF10072
Registrant's Address : 2-4-16 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2020-06-26
Latest Date of Registration : --
Registrant Name : Boryeong Co., Ltd.
Registration Date : 2020-11-13
Registration Number : 20201113-209-J-519
Manufacturer Name : Meiji Seika Pharma Co., Ltd.
Manufacturer Address : 2890, Kitagata, Kitagata-cho, Motosu-gun, Gifu-ken, Japan
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19011
Submission : 2005-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23544
Submission : 2010-04-15
Status : Inactive
Type : II
Registration Number : 219MF10254
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2007-08-06
Latest Date of Registration : --
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2019-12-19
Registration Number : 20191219-209-J-509
Manufacturer Name : Jeil Pharmaceutical Co., Ltd.
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong and others)
Registration Number : 228MF10040
Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea
Initial Date of Registration : 2016-02-08
Latest Date of Registration : --
Registration Number : 306MF10127
Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea
Initial Date of Registration : 2024-09-18
Latest Date of Registration : --
A Cefditoren Pivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefditoren Pivoxil, including repackagers and relabelers. The FDA regulates Cefditoren Pivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefditoren Pivoxil 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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