01 1Alps Pharmaceutical Co., Ltd.
02 1JEIL PHARMACEUTICAL CO. , LTD.
01 1Betamipron
02 1Panipenem
01 1Japan
02 1South Korea
Registration Number : 217MF11051
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2005-12-02
Latest Date of Registration : 2009-07-30
Registration Number : 221MF10039
Registrant's Address : 343, Sapyeong-daero, Seocho-gu, Seoul, Korea
Initial Date of Registration : 2009-02-23
Latest Date of Registration : 2013-06-05
A Panipenem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Panipenem, including repackagers and relabelers. The FDA regulates Panipenem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Panipenem 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 Panipenem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Panipenem supplier is an individual or a company that provides Panipenem active pharmaceutical ingredient (API) or Panipenem finished formulations upon request. The Panipenem suppliers may include Panipenem API manufacturers, exporters, distributors and traders.
click here to find a list of Panipenem 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 Panipenem Drug Master File in Japan (Panipenem JDMF) empowers Panipenem 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 Panipenem JDMF during the approval evaluation for pharmaceutical products. At the time of Panipenem 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 Panipenem suppliers with JDMF on PharmaCompass.
We have 2 companies offering Panipenem
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
