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JDMF
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KDMF
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VMF
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Canada
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Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
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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- CAPSULE, DELAYED REL PELLETS;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Fillers, Diluents & Binders
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Granulation
Solubilizers
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Topical
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Vegetarian Capsules
API Stability Enhancers
Chewable & Orodispersible Aids
Surfactant & Foaming Agents
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Global Sales Information
Market Place
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 LOA & ddI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LOA & ddI, including repackagers and relabelers. The FDA regulates LOA & ddI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LOA & ddI 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 LOA & ddI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A LOA & ddI supplier is an individual or a company that provides LOA & ddI active pharmaceutical ingredient (API) or LOA & ddI finished formulations upon request. The LOA & ddI suppliers may include LOA & ddI API manufacturers, exporters, distributors and traders.
click here to find a list of LOA & ddI suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A LOA & ddI DMF (Drug Master File) is a document detailing the whole manufacturing process of LOA & ddI active pharmaceutical ingredient (API) in detail. Different forms of LOA & ddI DMFs exist exist since differing nations have different regulations, such as LOA & ddI USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LOA & ddI DMF submitted to regulatory agencies in the US is known as a USDMF. LOA & ddI USDMF includes data on LOA & ddI's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LOA & ddI USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of LOA & ddI suppliers with USDMF on PharmaCompass.
A LOA & ddI CEP of the European Pharmacopoeia monograph is often referred to as a LOA & ddI Certificate of Suitability (COS). The purpose of a LOA & ddI CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of LOA & ddI EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of LOA & ddI to their clients by showing that a LOA & ddI CEP has been issued for it. The manufacturer submits a LOA & ddI CEP (COS) as part of the market authorization procedure, and it takes on the role of a LOA & ddI CEP holder for the record. Additionally, the data presented in the LOA & ddI CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the LOA & ddI DMF.
A LOA & ddI CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. LOA & ddI 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 LOA & ddI suppliers with CEP (COS) on PharmaCompass.
A LOA & ddI written confirmation (LOA & ddI WC) is an official document issued by a regulatory agency to a LOA & ddI manufacturer, verifying that the manufacturing facility of a LOA & ddI active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting LOA & ddI APIs or LOA & ddI finished pharmaceutical products to another nation, regulatory agencies frequently require a LOA & ddI WC (written confirmation) as part of the regulatory process.
click here to find a list of LOA & ddI 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 LOA & ddI as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for LOA & ddI 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 LOA & ddI 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 LOA & ddI and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a LOA & ddI NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of LOA & ddI suppliers with NDC on PharmaCompass.
LOA & ddI 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 LOA & ddI 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 LOA & ddI GMP manufacturer or LOA & ddI GMP API supplier for your needs.
A LOA & ddI CoA (Certificate of Analysis) is a formal document that attests to LOA & ddI's compliance with LOA & ddI specifications and serves as a tool for batch-level quality control.
LOA & ddI CoA mostly includes findings from lab analyses of a specific batch. For each LOA & ddI 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.
LOA & ddI may be tested according to a variety of international standards, such as European Pharmacopoeia (LOA & ddI EP), LOA & ddI JP (Japanese Pharmacopeia) and the US Pharmacopoeia (LOA & ddI USP).
