01 2Yashiro Pharmaceutical Co., Ltd.
01 2Phenobarbital sodium (Yashiro)
01 2Blank
Phenobarbital sodium (Yatsushiro)
Registration Number : 227MF10203
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2015-08-10
Latest Date of Registration : 2015-08-10
Phenobarbital sodium (Yatsushiro)
Registration Number : 218MF10254
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2010-03-25
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A Luminal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Luminal, including repackagers and relabelers. The FDA regulates Luminal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Luminal 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 Luminal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Luminal supplier is an individual or a company that provides Luminal active pharmaceutical ingredient (API) or Luminal finished formulations upon request. The Luminal suppliers may include Luminal API manufacturers, exporters, distributors and traders.
click here to find a list of Luminal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Luminal Drug Master File in Japan (Luminal JDMF) empowers Luminal 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 Luminal JDMF during the approval evaluation for pharmaceutical products. At the time of Luminal 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 Luminal suppliers with JDMF on PharmaCompass.
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