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API SUPPLIERS
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USDMF
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DOSAGE - FOR SOLUTION;ORAL - 10MG/ML
USFDA APPLICATION NUMBER - 20156
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21183
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21183
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21183
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21183
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Didanosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Didanosine, including repackagers and relabelers. The FDA regulates Didanosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Didanosine 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 Didanosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Didanosine supplier is an individual or a company that provides Didanosine active pharmaceutical ingredient (API) or Didanosine finished formulations upon request. The Didanosine suppliers may include Didanosine API manufacturers, exporters, distributors and traders.
click here to find a list of Didanosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Didanosine DMF (Drug Master File) is a document detailing the whole manufacturing process of Didanosine active pharmaceutical ingredient (API) in detail. Different forms of Didanosine DMFs exist exist since differing nations have different regulations, such as Didanosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Didanosine DMF submitted to regulatory agencies in the US is known as a USDMF. Didanosine USDMF includes data on Didanosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Didanosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Didanosine suppliers with USDMF on PharmaCompass.
A Didanosine CEP of the European Pharmacopoeia monograph is often referred to as a Didanosine Certificate of Suitability (COS). The purpose of a Didanosine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Didanosine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Didanosine to their clients by showing that a Didanosine CEP has been issued for it. The manufacturer submits a Didanosine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Didanosine CEP holder for the record. Additionally, the data presented in the Didanosine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Didanosine DMF.
A Didanosine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Didanosine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Didanosine suppliers with CEP (COS) on PharmaCompass.
A Didanosine written confirmation (Didanosine WC) is an official document issued by a regulatory agency to a Didanosine manufacturer, verifying that the manufacturing facility of a Didanosine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Didanosine APIs or Didanosine finished pharmaceutical products to another nation, regulatory agencies frequently require a Didanosine WC (written confirmation) as part of the regulatory process.
click here to find a list of Didanosine 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 Didanosine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Didanosine 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 Didanosine 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 Didanosine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Didanosine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Didanosine suppliers with NDC on PharmaCompass.
Didanosine 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 Didanosine 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 Didanosine GMP manufacturer or Didanosine GMP API supplier for your needs.
A Didanosine CoA (Certificate of Analysis) is a formal document that attests to Didanosine's compliance with Didanosine specifications and serves as a tool for batch-level quality control.
Didanosine CoA mostly includes findings from lab analyses of a specific batch. For each Didanosine 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.
Didanosine may be tested according to a variety of international standards, such as European Pharmacopoeia (Didanosine EP), Didanosine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Didanosine USP).
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