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