01 1Piramal Enterprises Limited
01 1Halothane
01 1India
Registration Number : 220MF10150
Registrant's Address : 5-9-30, Basheerbahg Palace colony, Road No. 4, Basheerbahg, Hyderabad 500 063, Telang...
Initial Date of Registration : 2008-06-23
Latest Date of Registration : 2015-02-09
A Fluothane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluothane, including repackagers and relabelers. The FDA regulates Fluothane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluothane 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 Fluothane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluothane supplier is an individual or a company that provides Fluothane active pharmaceutical ingredient (API) or Fluothane finished formulations upon request. The Fluothane suppliers may include Fluothane API manufacturers, exporters, distributors and traders.
click here to find a list of Fluothane 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 Fluothane Drug Master File in Japan (Fluothane JDMF) empowers Fluothane 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 Fluothane JDMF during the approval evaluation for pharmaceutical products. At the time of Fluothane 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 Fluothane suppliers with JDMF on PharmaCompass.
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