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API SUPPLIERS
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FDF Dossiers
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ABOUT THIS PAGE
A Urea C13 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urea C13, including repackagers and relabelers. The FDA regulates Urea C13 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urea C13 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 Urea C13 supplier is an individual or a company that provides Urea C13 active pharmaceutical ingredient (API) or Urea C13 finished formulations upon request. The Urea C13 suppliers may include Urea C13 API manufacturers, exporters, distributors and traders.
click here to find a list of Urea C13 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 Urea C13 Drug Master File in Japan (Urea C13 JDMF) empowers Urea C13 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 Urea C13 JDMF during the approval evaluation for pharmaceutical products. At the time of Urea C13 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 Urea C13 suppliers with JDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Urea C13 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Urea C13 API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Urea C13 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Urea C13 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Urea C13 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Urea C13 suppliers with NDC on PharmaCompass.
Urea C13 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Urea C13 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Urea C13 GMP manufacturer or Urea C13 GMP API supplier for your needs.
A Urea C13 CoA (Certificate of Analysis) is a formal document that attests to Urea C13's compliance with Urea C13 specifications and serves as a tool for batch-level quality control.
Urea C13 CoA mostly includes findings from lab analyses of a specific batch. For each Urea C13 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Urea C13 may be tested according to a variety of international standards, such as European Pharmacopoeia (Urea C13 EP), Urea C13 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Urea C13 USP).
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