US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Amifampridine Phosphate 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 Amifampridine Phosphate manufacturer or Amifampridine Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amifampridine Phosphate manufacturer or Amifampridine Phosphate supplier.
PharmaCompass also assists you with knowing the Amifampridine Phosphate API Price utilized in the formulation of products. Amifampridine Phosphate API Price is not always fixed or binding as the Amifampridine Phosphate Price is obtained through a variety of data sources. The Amifampridine Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amifampridine Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amifampridine Phosphate, including repackagers and relabelers. The FDA regulates Amifampridine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amifampridine Phosphate 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 Amifampridine Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amifampridine Phosphate supplier is an individual or a company that provides Amifampridine Phosphate active pharmaceutical ingredient (API) or Amifampridine Phosphate finished formulations upon request. The Amifampridine Phosphate suppliers may include Amifampridine Phosphate API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Amifampridine Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amifampridine Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amifampridine Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Amifampridine Phosphate DMFs exist exist since differing nations have different regulations, such as Amifampridine Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amifampridine Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Amifampridine Phosphate USDMF includes data on Amifampridine Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amifampridine Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Amifampridine Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amifampridine Phosphate 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 Amifampridine Phosphate 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 Amifampridine Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amifampridine Phosphate NDC to their finished compounded human drug products, they may choose to do so.
CLICK HERE to find a list of Amifampridine Phosphate suppliers with NDC on PharmaCompass.
Amifampridine Phosphate 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 Amifampridine Phosphate 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 Amifampridine Phosphate GMP manufacturer or Amifampridine Phosphate GMP API supplier for your needs.
A Amifampridine Phosphate CoA (Certificate of Analysis) is a formal document that attests to Amifampridine Phosphate's compliance with Amifampridine Phosphate specifications and serves as a tool for batch-level quality control.
Amifampridine Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Amifampridine Phosphate 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.
Amifampridine Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Amifampridine Phosphate EP), Amifampridine Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amifampridine Phosphate USP).