01 1RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S. P. A.
01 1Karugurumin acid
01 1Italy
Registration Number : 227MF10276
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2015-12-11
Latest Date of Registration : 2016-08-16
A N-Carbamylglutamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Carbamylglutamate, including repackagers and relabelers. The FDA regulates N-Carbamylglutamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Carbamylglutamate 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 N-Carbamylglutamate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A N-Carbamylglutamate supplier is an individual or a company that provides N-Carbamylglutamate active pharmaceutical ingredient (API) or N-Carbamylglutamate finished formulations upon request. The N-Carbamylglutamate suppliers may include N-Carbamylglutamate API manufacturers, exporters, distributors and traders.
click here to find a list of N-Carbamylglutamate 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 N-Carbamylglutamate Drug Master File in Japan (N-Carbamylglutamate JDMF) empowers N-Carbamylglutamate 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 N-Carbamylglutamate JDMF during the approval evaluation for pharmaceutical products. At the time of N-Carbamylglutamate 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 N-Carbamylglutamate suppliers with JDMF on PharmaCompass.
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