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 Penbritin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penbritin, including repackagers and relabelers. The FDA regulates Penbritin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penbritin 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 Penbritin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Penbritin supplier is an individual or a company that provides Penbritin active pharmaceutical ingredient (API) or Penbritin finished formulations upon request. The Penbritin suppliers may include Penbritin API manufacturers, exporters, distributors and traders.
click here to find a list of Penbritin 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 Penbritin Drug Master File in Japan (Penbritin JDMF) empowers Penbritin 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 Penbritin JDMF during the approval evaluation for pharmaceutical products. At the time of Penbritin 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 Penbritin suppliers with JDMF on PharmaCompass.
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