01 1ACS DOBFAR S. p. A.
02 1CJ CheilJedang Corporation
03 2HANMI FINE CHEMICAL CO. , LTD.
04 1Qilu Antibiotics Pharmaceutical Co. , Ltd.
05 1Yungjin Pharm. Co. ,Ltd
01 2Ceftazidime Hydrate
02 3Ceftazidime hydrate
03 1Sterile ceftazidime hydrate
01 1China
02 1Italy
03 4South Korea
Registration Number : 305MF10039
Registrant's Address : Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Initial Date of Registration : 2023-03-23
Latest Date of Registration : 2024-05-08
Registration Number : 219MF10143
Registrant's Address : CJ CheilJedang Building 292, Ssangnim-dong, Jung-gu, Seoul, 100-400, Korea
Initial Date of Registration : 2007-04-27
Latest Date of Registration : 2009-07-09
Registration Number : 225MF10225
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2013-12-10
Latest Date of Registration : 2013-12-10
Registration Number : 219MF10007
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2007-01-18
Latest Date of Registration : 2018-07-26
Registration Number : 302MF10077
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2020-07-06
Latest Date of Registration : 2020-07-06
Registration Number : 221MF10184
Registrant's Address : 13, Olympic-ro 35da-gil, Songpa-gu, Seoul, Korea
Initial Date of Registration : 2009-08-13
Latest Date of Registration : 2014-09-01
A AVYCAZ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AVYCAZ, including repackagers and relabelers. The FDA regulates AVYCAZ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AVYCAZ API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of AVYCAZ manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AVYCAZ supplier is an individual or a company that provides AVYCAZ active pharmaceutical ingredient (API) or AVYCAZ finished formulations upon request. The AVYCAZ suppliers may include AVYCAZ API manufacturers, exporters, distributors and traders.
click here to find a list of AVYCAZ suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The AVYCAZ Drug Master File in Japan (AVYCAZ JDMF) empowers AVYCAZ API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the AVYCAZ JDMF during the approval evaluation for pharmaceutical products. At the time of AVYCAZ JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of AVYCAZ suppliers with JDMF on PharmaCompass.
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