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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]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 its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
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...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
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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.
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).
