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Canada
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DRUG PRODUCT COMPOSITIONS0
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API
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Data Compilation #PharmaFlow
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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- CAPSULE, DELAYED REL PELLETS;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
Evonik
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Controlled & Modified Release
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
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Solubilizers
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Topical
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API Stability Enhancers
Emulsifying Agents
Chewable & Orodispersible Aids
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Global Sales Information
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
20
PharmaCompass offers a list of Didanosine 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 Didanosine manufacturer or Didanosine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Didanosine manufacturer or Didanosine supplier.
PharmaCompass also assists you with knowing the Didanosine API Price utilized in the formulation of products. Didanosine API Price is not always fixed or binding as the Didanosine Price is obtained through a variety of data sources. The Didanosine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein), including repackagers and relabelers. The FDA regulates 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) supplier is an individual or a company that provides 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) active pharmaceutical ingredient (API) or 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) finished formulations upon request. The 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) suppliers may include 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) API manufacturers, exporters, distributors and traders.
click here to find a list of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) DMF (Drug Master File) is a document detailing the whole manufacturing process of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) active pharmaceutical ingredient (API) in detail. Different forms of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) DMFs exist exist since differing nations have different regulations, such as 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) DMF submitted to regulatory agencies in the US is known as a USDMF. 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) USDMF includes data on 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) suppliers with USDMF on PharmaCompass.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CEP of the European Pharmacopoeia monograph is often referred to as a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) Certificate of Suitability (COS). The purpose of a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) to their clients by showing that a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CEP has been issued for it. The manufacturer submits a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CEP (COS) as part of the market authorization procedure, and it takes on the role of a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CEP holder for the record. Additionally, the data presented in the 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) DMF.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) suppliers with CEP (COS) on PharmaCompass.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) written confirmation (2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) WC) is an official document issued by a regulatory agency to a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) manufacturer, verifying that the manufacturing facility of a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) APIs or 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) finished pharmaceutical products to another nation, regulatory agencies frequently require a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) WC (written confirmation) as part of the regulatory process.
click here to find a list of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) suppliers with NDC on PharmaCompass.
2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) GMP manufacturer or 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) GMP API supplier for your needs.
A 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CoA (Certificate of Analysis) is a formal document that attests to 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein)'s compliance with 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) specifications and serves as a tool for batch-level quality control.
2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) CoA mostly includes findings from lab analyses of a specific batch. For each 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) 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.
2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) may be tested according to a variety of international standards, such as European Pharmacopoeia (2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) EP), 2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2',3'-Dideoxyinosine & sCD4(soluble recombinant protein) USP).
