Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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FDF
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Weekly News Recap #Phispers
API SUPPLIERS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Neuland Laboratories- A dedicated 100% API provider.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40592
Submission : 2024-09-27
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Date of Issue : 2025-07-17
Valid Till : 2028-08-26
Written Confirmation Number : SD250073
Address of the Firm : No. 127, Qizhong Avenue, Qihe County, Dezhou City, Shandong Province, China
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic ca...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical is a wholly owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Located in the Qihe Economic Development Zone, Sh...
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&...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Fezolinetant 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 Fezolinetant manufacturer or Fezolinetant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fezolinetant manufacturer or Fezolinetant supplier.
PharmaCompass also assists you with knowing the Fezolinetant API Price utilized in the formulation of products. Fezolinetant API Price is not always fixed or binding as the Fezolinetant Price is obtained through a variety of data sources. The Fezolinetant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fezolinetant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fezolinetant, including repackagers and relabelers. The FDA regulates Fezolinetant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fezolinetant 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 Fezolinetant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fezolinetant supplier is an individual or a company that provides Fezolinetant active pharmaceutical ingredient (API) or Fezolinetant finished formulations upon request. The Fezolinetant suppliers may include Fezolinetant API manufacturers, exporters, distributors and traders.
click here to find a list of Fezolinetant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fezolinetant DMF (Drug Master File) is a document detailing the whole manufacturing process of Fezolinetant active pharmaceutical ingredient (API) in detail. Different forms of Fezolinetant DMFs exist exist since differing nations have different regulations, such as Fezolinetant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fezolinetant DMF submitted to regulatory agencies in the US is known as a USDMF. Fezolinetant USDMF includes data on Fezolinetant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fezolinetant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fezolinetant suppliers with USDMF on PharmaCompass.
A Fezolinetant written confirmation (Fezolinetant WC) is an official document issued by a regulatory agency to a Fezolinetant manufacturer, verifying that the manufacturing facility of a Fezolinetant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fezolinetant APIs or Fezolinetant finished pharmaceutical products to another nation, regulatory agencies frequently require a Fezolinetant WC (written confirmation) as part of the regulatory process.
click here to find a list of Fezolinetant 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 Fezolinetant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fezolinetant 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 Fezolinetant 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 Fezolinetant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fezolinetant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fezolinetant suppliers with NDC on PharmaCompass.
Fezolinetant 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 Fezolinetant 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 Fezolinetant GMP manufacturer or Fezolinetant GMP API supplier for your needs.
A Fezolinetant CoA (Certificate of Analysis) is a formal document that attests to Fezolinetant's compliance with Fezolinetant specifications and serves as a tool for batch-level quality control.
Fezolinetant CoA mostly includes findings from lab analyses of a specific batch. For each Fezolinetant 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.
Fezolinetant may be tested according to a variety of international standards, such as European Pharmacopoeia (Fezolinetant EP), Fezolinetant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fezolinetant USP).
