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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-10
Pay. Date : 2015-02-05
DMF Number : 28996
Submission : 2015-01-30
Status :
Type : II
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Foscarnet Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Foscarnet Sodium, including repackagers and relabelers. The FDA regulates Foscarnet Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Foscarnet Sodium 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 Foscarnet Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Foscarnet Sodium supplier is an individual or a company that provides Foscarnet Sodium active pharmaceutical ingredient (API) or Foscarnet Sodium finished formulations upon request. The Foscarnet Sodium suppliers may include Foscarnet Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Foscarnet Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Foscarnet Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Foscarnet Sodium active pharmaceutical ingredient (API) in detail. Different forms of Foscarnet Sodium DMFs exist exist since differing nations have different regulations, such as Foscarnet Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Foscarnet Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Foscarnet Sodium USDMF includes data on Foscarnet Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Foscarnet Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Foscarnet Sodium suppliers with USDMF on PharmaCompass.
A Foscarnet Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Foscarnet Sodium Certificate of Suitability (COS). The purpose of a Foscarnet Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Foscarnet Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Foscarnet Sodium to their clients by showing that a Foscarnet Sodium CEP has been issued for it. The manufacturer submits a Foscarnet Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Foscarnet Sodium CEP holder for the record. Additionally, the data presented in the Foscarnet Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Foscarnet Sodium DMF.
A Foscarnet Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Foscarnet Sodium 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 Foscarnet Sodium suppliers with CEP (COS) on PharmaCompass.
A Foscarnet Sodium written confirmation (Foscarnet Sodium WC) is an official document issued by a regulatory agency to a Foscarnet Sodium manufacturer, verifying that the manufacturing facility of a Foscarnet Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Foscarnet Sodium APIs or Foscarnet Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Foscarnet Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Foscarnet Sodium 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 Foscarnet Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Foscarnet Sodium 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 Foscarnet Sodium 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 Foscarnet Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Foscarnet Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Foscarnet Sodium suppliers with NDC on PharmaCompass.
Foscarnet Sodium 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 Foscarnet Sodium 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 Foscarnet Sodium GMP manufacturer or Foscarnet Sodium GMP API supplier for your needs.
A Foscarnet Sodium CoA (Certificate of Analysis) is a formal document that attests to Foscarnet Sodium's compliance with Foscarnet Sodium specifications and serves as a tool for batch-level quality control.
Foscarnet Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Foscarnet Sodium 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.
Foscarnet Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Foscarnet Sodium EP), Foscarnet Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Foscarnet Sodium USP).
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