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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2025-09-03
Pay. Date : 2025-07-09
DMF Number : 42238
Submission : 2025-07-29
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-08-22
Pay. Date : 2025-07-14
DMF Number : 41809
Submission : 2025-04-30
Status :
Type : II
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Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
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 Maralixibat Chloride 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 Maralixibat Chloride manufacturer or Maralixibat Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Maralixibat Chloride manufacturer or Maralixibat Chloride supplier.
PharmaCompass also assists you with knowing the Maralixibat Chloride API Price utilized in the formulation of products. Maralixibat Chloride API Price is not always fixed or binding as the Maralixibat Chloride Price is obtained through a variety of data sources. The Maralixibat Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Maralixibat Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maralixibat Chloride, including repackagers and relabelers. The FDA regulates Maralixibat Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maralixibat Chloride 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 Maralixibat Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maralixibat Chloride supplier is an individual or a company that provides Maralixibat Chloride active pharmaceutical ingredient (API) or Maralixibat Chloride finished formulations upon request. The Maralixibat Chloride suppliers may include Maralixibat Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Maralixibat Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maralixibat Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Maralixibat Chloride active pharmaceutical ingredient (API) in detail. Different forms of Maralixibat Chloride DMFs exist exist since differing nations have different regulations, such as Maralixibat Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maralixibat Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Maralixibat Chloride USDMF includes data on Maralixibat Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maralixibat Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maralixibat Chloride suppliers with USDMF 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 Maralixibat Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Maralixibat Chloride 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 Maralixibat Chloride 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 Maralixibat Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Maralixibat Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Maralixibat Chloride suppliers with NDC on PharmaCompass.
Maralixibat Chloride 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 Maralixibat Chloride 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 Maralixibat Chloride GMP manufacturer or Maralixibat Chloride GMP API supplier for your needs.
A Maralixibat Chloride CoA (Certificate of Analysis) is a formal document that attests to Maralixibat Chloride's compliance with Maralixibat Chloride specifications and serves as a tool for batch-level quality control.
Maralixibat Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Maralixibat Chloride 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.
Maralixibat Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Maralixibat Chloride EP), Maralixibat Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maralixibat Chloride USP).
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