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