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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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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 : 2015-11-06
Pay. Date : 2015-08-25
DMF Number : 29507
Submission : 2015-07-04
Status :
Type : II
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
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PharmaCompass offers a list of Plerixafor 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 Plerixafor manufacturer or Plerixafor supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Plerixafor manufacturer or Plerixafor supplier.
PharmaCompass also assists you with knowing the Plerixafor API Price utilized in the formulation of products. Plerixafor API Price is not always fixed or binding as the Plerixafor Price is obtained through a variety of data sources. The Plerixafor Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Plerixafor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Plerixafor, including repackagers and relabelers. The FDA regulates Plerixafor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Plerixafor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Plerixafor supplier is an individual or a company that provides Plerixafor active pharmaceutical ingredient (API) or Plerixafor finished formulations upon request. The Plerixafor suppliers may include Plerixafor API manufacturers, exporters, distributors and traders.
click here to find a list of Plerixafor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Plerixafor DMF (Drug Master File) is a document detailing the whole manufacturing process of Plerixafor active pharmaceutical ingredient (API) in detail. Different forms of Plerixafor DMFs exist exist since differing nations have different regulations, such as Plerixafor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Plerixafor DMF submitted to regulatory agencies in the US is known as a USDMF. Plerixafor USDMF includes data on Plerixafor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Plerixafor USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Plerixafor written confirmation (Plerixafor WC) is an official document issued by a regulatory agency to a Plerixafor manufacturer, verifying that the manufacturing facility of a Plerixafor active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Plerixafor APIs or Plerixafor finished pharmaceutical products to another nation, regulatory agencies frequently require a Plerixafor WC (written confirmation) as part of the regulatory process.
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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 Plerixafor as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Plerixafor 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 Plerixafor 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 Plerixafor and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Plerixafor NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Plerixafor suppliers with NDC on PharmaCompass.
Plerixafor 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 Plerixafor 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 Plerixafor GMP manufacturer or Plerixafor GMP API supplier for your needs.
A Plerixafor CoA (Certificate of Analysis) is a formal document that attests to Plerixafor's compliance with Plerixafor specifications and serves as a tool for batch-level quality control.
Plerixafor CoA mostly includes findings from lab analyses of a specific batch. For each Plerixafor 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.
Plerixafor may be tested according to a variety of international standards, such as European Pharmacopoeia (Plerixafor EP), Plerixafor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Plerixafor USP).
