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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.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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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.
Certificate Number : R0-CEP 2020-337 - Rev 00
Status : Valid
Issue Date : 2023-02-14
Type : Chemical
Substance Number : 1520
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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...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
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PharmaCompass offers a list of Foscarnet Sodium 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 Foscarnet Sodium manufacturer or Foscarnet Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Foscarnet Sodium manufacturer or Foscarnet Sodium supplier.
PharmaCompass also assists you with knowing the Foscarnet Sodium API Price utilized in the formulation of products. Foscarnet Sodium API Price is not always fixed or binding as the Foscarnet Sodium Price is obtained through a variety of data sources. The Foscarnet Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Triapten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triapten, including repackagers and relabelers. The FDA regulates Triapten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triapten 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 Triapten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Triapten supplier is an individual or a company that provides Triapten active pharmaceutical ingredient (API) or Triapten finished formulations upon request. The Triapten suppliers may include Triapten API manufacturers, exporters, distributors and traders.
click here to find a list of Triapten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Triapten DMF (Drug Master File) is a document detailing the whole manufacturing process of Triapten active pharmaceutical ingredient (API) in detail. Different forms of Triapten DMFs exist exist since differing nations have different regulations, such as Triapten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triapten DMF submitted to regulatory agencies in the US is known as a USDMF. Triapten USDMF includes data on Triapten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triapten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Triapten suppliers with USDMF on PharmaCompass.
A Triapten CEP of the European Pharmacopoeia monograph is often referred to as a Triapten Certificate of Suitability (COS). The purpose of a Triapten CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Triapten EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Triapten to their clients by showing that a Triapten CEP has been issued for it. The manufacturer submits a Triapten CEP (COS) as part of the market authorization procedure, and it takes on the role of a Triapten CEP holder for the record. Additionally, the data presented in the Triapten CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Triapten DMF.
A Triapten CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Triapten 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 Triapten suppliers with CEP (COS) on PharmaCompass.
A Triapten written confirmation (Triapten WC) is an official document issued by a regulatory agency to a Triapten manufacturer, verifying that the manufacturing facility of a Triapten active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Triapten APIs or Triapten finished pharmaceutical products to another nation, regulatory agencies frequently require a Triapten WC (written confirmation) as part of the regulatory process.
click here to find a list of Triapten 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 Triapten as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Triapten 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 Triapten 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 Triapten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Triapten NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Triapten suppliers with NDC on PharmaCompass.
Triapten 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 Triapten 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 Triapten GMP manufacturer or Triapten GMP API supplier for your needs.
A Triapten CoA (Certificate of Analysis) is a formal document that attests to Triapten's compliance with Triapten specifications and serves as a tool for batch-level quality control.
Triapten CoA mostly includes findings from lab analyses of a specific batch. For each Triapten 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.
Triapten may be tested according to a variety of international standards, such as European Pharmacopoeia (Triapten EP), Triapten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Triapten USP).
