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ABOUT THIS PAGE
A Aminohippuric Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aminohippuric Acid, including repackagers and relabelers. The FDA regulates Aminohippuric Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aminohippuric Acid 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 Aminohippuric Acid supplier is an individual or a company that provides Aminohippuric Acid active pharmaceutical ingredient (API) or Aminohippuric Acid finished formulations upon request. The Aminohippuric Acid suppliers may include Aminohippuric Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Aminohippuric Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aminohippuric Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Aminohippuric Acid active pharmaceutical ingredient (API) in detail. Different forms of Aminohippuric Acid DMFs exist exist since differing nations have different regulations, such as Aminohippuric Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aminohippuric Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Aminohippuric Acid USDMF includes data on Aminohippuric Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aminohippuric Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aminohippuric Acid suppliers with USDMF 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 Aminohippuric Acid Drug Master File in Japan (Aminohippuric Acid JDMF) empowers Aminohippuric Acid 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 Aminohippuric Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Aminohippuric Acid 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 Aminohippuric Acid 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 Aminohippuric Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aminohippuric Acid 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 Aminohippuric Acid 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 Aminohippuric Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aminohippuric Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aminohippuric Acid suppliers with NDC on PharmaCompass.
Aminohippuric Acid 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 Aminohippuric Acid 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 Aminohippuric Acid GMP manufacturer or Aminohippuric Acid GMP API supplier for your needs.
A Aminohippuric Acid CoA (Certificate of Analysis) is a formal document that attests to Aminohippuric Acid's compliance with Aminohippuric Acid specifications and serves as a tool for batch-level quality control.
Aminohippuric Acid CoA mostly includes findings from lab analyses of a specific batch. For each Aminohippuric Acid 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.
Aminohippuric Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Aminohippuric Acid EP), Aminohippuric Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aminohippuric Acid USP).
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