01 1Norbrook s. r. o.
01 1Japanese Pharmacopoeia ethyl benzoate (prepared only)
01 1Czech Republic
Japanese Pharmacopoeia Ethyl Aminobenzoate (For manufacturing purposes only)
Registration Number : 218MF11008
Registrant's Address : c. p. 323, 533 54 Rybitvi, Czech Republic
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2006-12-18
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A Ethyl 4-Butylamino-Benzoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethyl 4-Butylamino-Benzoate, including repackagers and relabelers. The FDA regulates Ethyl 4-Butylamino-Benzoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethyl 4-Butylamino-Benzoate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ethyl 4-Butylamino-Benzoate supplier is an individual or a company that provides Ethyl 4-Butylamino-Benzoate active pharmaceutical ingredient (API) or Ethyl 4-Butylamino-Benzoate finished formulations upon request. The Ethyl 4-Butylamino-Benzoate suppliers may include Ethyl 4-Butylamino-Benzoate API manufacturers, exporters, distributors and traders.
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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 Ethyl 4-Butylamino-Benzoate Drug Master File in Japan (Ethyl 4-Butylamino-Benzoate JDMF) empowers Ethyl 4-Butylamino-Benzoate 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 Ethyl 4-Butylamino-Benzoate JDMF during the approval evaluation for pharmaceutical products. At the time of Ethyl 4-Butylamino-Benzoate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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