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