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API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-23
Pay. Date : 2019-12-12
DMF Number : 35049
Submission : 2020-08-12
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-04
Pay. Date : 2024-10-25
DMF Number : 36081
Submission : 2021-07-22
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Nelarabine 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 Nelarabine manufacturer or Nelarabine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nelarabine manufacturer or Nelarabine supplier.
PharmaCompass also assists you with knowing the Nelarabine API Price utilized in the formulation of products. Nelarabine API Price is not always fixed or binding as the Nelarabine Price is obtained through a variety of data sources. The Nelarabine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Arranon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arranon, including repackagers and relabelers. The FDA regulates Arranon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arranon 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 Arranon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arranon supplier is an individual or a company that provides Arranon active pharmaceutical ingredient (API) or Arranon finished formulations upon request. The Arranon suppliers may include Arranon API manufacturers, exporters, distributors and traders.
click here to find a list of Arranon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arranon DMF (Drug Master File) is a document detailing the whole manufacturing process of Arranon active pharmaceutical ingredient (API) in detail. Different forms of Arranon DMFs exist exist since differing nations have different regulations, such as Arranon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arranon DMF submitted to regulatory agencies in the US is known as a USDMF. Arranon USDMF includes data on Arranon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arranon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arranon suppliers with USDMF on PharmaCompass.
A Arranon written confirmation (Arranon WC) is an official document issued by a regulatory agency to a Arranon manufacturer, verifying that the manufacturing facility of a Arranon active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Arranon APIs or Arranon finished pharmaceutical products to another nation, regulatory agencies frequently require a Arranon WC (written confirmation) as part of the regulatory process.
click here to find a list of Arranon 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 Arranon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Arranon 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 Arranon 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 Arranon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Arranon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Arranon suppliers with NDC on PharmaCompass.
Arranon 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 Arranon 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 Arranon GMP manufacturer or Arranon GMP API supplier for your needs.
A Arranon CoA (Certificate of Analysis) is a formal document that attests to Arranon's compliance with Arranon specifications and serves as a tool for batch-level quality control.
Arranon CoA mostly includes findings from lab analyses of a specific batch. For each Arranon 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.
Arranon may be tested according to a variety of international standards, such as European Pharmacopoeia (Arranon EP), Arranon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Arranon USP).
