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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- CAPSULE, DELAYED REL PELLETS;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, DELAYED REL PELLETS;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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Evonik
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ABOUT THIS PAGE
42
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 2DI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2DI, including repackagers and relabelers. The FDA regulates 2DI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2DI 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 2DI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 2DI supplier is an individual or a company that provides 2DI active pharmaceutical ingredient (API) or 2DI finished formulations upon request. The 2DI suppliers may include 2DI API manufacturers, exporters, distributors and traders.
click here to find a list of 2DI suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 2DI DMF (Drug Master File) is a document detailing the whole manufacturing process of 2DI active pharmaceutical ingredient (API) in detail. Different forms of 2DI DMFs exist exist since differing nations have different regulations, such as 2DI USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2DI DMF submitted to regulatory agencies in the US is known as a USDMF. 2DI USDMF includes data on 2DI's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2DI USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 2DI suppliers with USDMF on PharmaCompass.
A 2DI CEP of the European Pharmacopoeia monograph is often referred to as a 2DI Certificate of Suitability (COS). The purpose of a 2DI CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 2DI EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 2DI to their clients by showing that a 2DI CEP has been issued for it. The manufacturer submits a 2DI CEP (COS) as part of the market authorization procedure, and it takes on the role of a 2DI CEP holder for the record. Additionally, the data presented in the 2DI CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 2DI DMF.
A 2DI CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 2DI 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 2DI suppliers with CEP (COS) on PharmaCompass.
A 2DI written confirmation (2DI WC) is an official document issued by a regulatory agency to a 2DI manufacturer, verifying that the manufacturing facility of a 2DI active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2DI APIs or 2DI finished pharmaceutical products to another nation, regulatory agencies frequently require a 2DI WC (written confirmation) as part of the regulatory process.
click here to find a list of 2DI 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 2DI as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 2DI 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 2DI 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 2DI and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2DI NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 2DI suppliers with NDC on PharmaCompass.
2DI 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 2DI 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 2DI GMP manufacturer or 2DI GMP API supplier for your needs.
A 2DI CoA (Certificate of Analysis) is a formal document that attests to 2DI's compliance with 2DI specifications and serves as a tool for batch-level quality control.
2DI CoA mostly includes findings from lab analyses of a specific batch. For each 2DI 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.
2DI may be tested according to a variety of international standards, such as European Pharmacopoeia (2DI EP), 2DI JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2DI USP).
