01 1Shiratori Pharmaceutical Co., Ltd.
01 1Pimobendan production dedicated
01 1Japan
Pimobendan For manufacturing purposes only
Registration Number : 218MF10997
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2006-12-18
A Pimobendan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pimobendan, including repackagers and relabelers. The FDA regulates Pimobendan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pimobendan 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 Pimobendan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pimobendan supplier is an individual or a company that provides Pimobendan active pharmaceutical ingredient (API) or Pimobendan finished formulations upon request. The Pimobendan suppliers may include Pimobendan API manufacturers, exporters, distributors and traders.
click here to find a list of Pimobendan 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 Pimobendan Drug Master File in Japan (Pimobendan JDMF) empowers Pimobendan 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 Pimobendan JDMF during the approval evaluation for pharmaceutical products. At the time of Pimobendan 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 Pimobendan suppliers with JDMF on PharmaCompass.
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