01 1ACS Dobfar SpA@ACS DOBFAR SpA
02 1Hanmi Precision Chemical Co., Ltd.
03 2Liaoning Medya Pharmaceutical Co., Ltd
01 1Hanmi Precision Chemical Co., Ltd.
02 1Korea Pfizer Pharmaceutical Co., Ltd.
03 2Kyungbo Pharmaceutical Co., Ltd.
01 1Ceftazidime hydrate and dried sodium carbonate
02 3Septazidim Hydrogen Cargo
01 1Italy
02 3South Korea
Ceftazidime hydrate and dried sodium carbonate
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2022-12-22
Registration Number : 20221222-210-J-1424
Manufacturer Name : ACS Dobfar SpA@ACS DOBFAR Sp...
Manufacturer Address : Viale Addetta, 2a/12–3/5, 20067 Tribiano (MI), Italy@Via Marzabotto, 1, 7/9 20871 V...
Registrant Name : Hanmi Precision Chemical Co., Ltd.
Registration Date : 2020-01-20
Registration Number : 20200120-210-J-541
Manufacturer Name : Hanmi Precision Chemical Co....
Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2020-06-02
Registration Number : 20200602-210-J-645
Manufacturer Name : Liaoning Medya Pharmaceutica...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @Technology City, Fushun Economic Developmen...
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2020-04-24
Registration Number : 20200424-210-J-614
Manufacturer Name : Liaoning Medya Pharmaceutica...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @Technology City, Fushun Economic Developmen...
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.
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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.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a AVYCAZ Drug Master File in Korea (AVYCAZ KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AVYCAZ. The MFDS reviews the AVYCAZ KDMF as part of the drug registration process and uses the information provided in the AVYCAZ KDMF to evaluate the safety and efficacy of the drug.
After submitting a AVYCAZ KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their AVYCAZ API can apply through the Korea Drug Master File (KDMF).
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