01 1DAEWOONG BIO INC.
02 1Inner Mongolia Changsheng Pharmaceutical Co. , Ltd.
03 1North China Pharmaceutical Group Semisyntech Co. , Ltd.
01 2Ampicillin hydrate
02 1[Japanese Pharmacopoeia] ampicillin
01 2China
02 1South Korea
[Japanese Pharmacopoeia] Ampicillin
Registration Number : 218MF11025
Registrant's Address : 12 BONGEUNSA-RO, 114-GIL, GANGNAM-GU, SEOUL, 135-715 KOREA
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2006-12-28
Registration Number : 302MF10096
Registrant's Address : Industry Zone, Tuoketuo, Hohhot, Inner Mongolia, China
Initial Date of Registration : 2020-08-05
Latest Date of Registration : 2023-01-25
Registration Number : 301MF10028
Registrant's Address : No. 20 Yangzi Road, Shijiazhuang Economic and Technological Development Zone, Hebei 0...
Initial Date of Registration : 2019-07-05
Latest Date of Registration : 2019-07-05
A AMPICILLIN/AMPICILLIN TRIHYDRATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMPICILLIN/AMPICILLIN TRIHYDRATE, including repackagers and relabelers. The FDA regulates AMPICILLIN/AMPICILLIN TRIHYDRATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMPICILLIN/AMPICILLIN TRIHYDRATE 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 AMPICILLIN/AMPICILLIN TRIHYDRATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AMPICILLIN/AMPICILLIN TRIHYDRATE supplier is an individual or a company that provides AMPICILLIN/AMPICILLIN TRIHYDRATE active pharmaceutical ingredient (API) or AMPICILLIN/AMPICILLIN TRIHYDRATE finished formulations upon request. The AMPICILLIN/AMPICILLIN TRIHYDRATE suppliers may include AMPICILLIN/AMPICILLIN TRIHYDRATE API manufacturers, exporters, distributors and traders.
click here to find a list of AMPICILLIN/AMPICILLIN TRIHYDRATE 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 AMPICILLIN/AMPICILLIN TRIHYDRATE Drug Master File in Japan (AMPICILLIN/AMPICILLIN TRIHYDRATE JDMF) empowers AMPICILLIN/AMPICILLIN TRIHYDRATE 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 AMPICILLIN/AMPICILLIN TRIHYDRATE JDMF during the approval evaluation for pharmaceutical products. At the time of AMPICILLIN/AMPICILLIN TRIHYDRATE 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 AMPICILLIN/AMPICILLIN TRIHYDRATE suppliers with JDMF on PharmaCompass.
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