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
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PharmaCompass offers a list of Carglumic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Carglumic Acid manufacturer or Carglumic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carglumic Acid manufacturer or Carglumic Acid supplier.
PharmaCompass also assists you with knowing the Carglumic Acid API Price utilized in the formulation of products. Carglumic Acid API Price is not always fixed or binding as the Carglumic Acid Price is obtained through a variety of data sources. The Carglumic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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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.
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