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