Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
FDF
0
Weekly News Recap #Phispers
API SUPPLIERS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Click Us!
Neuland Laboratories- A dedicated 100% API provider.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
Global Sales Information
Market Place
ABOUT THIS PAGE
90
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 ESN-364 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ESN-364, including repackagers and relabelers. The FDA regulates ESN-364 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ESN-364 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 ESN-364 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ESN-364 supplier is an individual or a company that provides ESN-364 active pharmaceutical ingredient (API) or ESN-364 finished formulations upon request. The ESN-364 suppliers may include ESN-364 API manufacturers, exporters, distributors and traders.
click here to find a list of ESN-364 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ESN-364 DMF (Drug Master File) is a document detailing the whole manufacturing process of ESN-364 active pharmaceutical ingredient (API) in detail. Different forms of ESN-364 DMFs exist exist since differing nations have different regulations, such as ESN-364 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ESN-364 DMF submitted to regulatory agencies in the US is known as a USDMF. ESN-364 USDMF includes data on ESN-364's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ESN-364 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ESN-364 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 ESN-364 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ESN-364 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 ESN-364 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 ESN-364 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ESN-364 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ESN-364 suppliers with NDC on PharmaCompass.
ESN-364 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 ESN-364 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 ESN-364 GMP manufacturer or ESN-364 GMP API supplier for your needs.
A ESN-364 CoA (Certificate of Analysis) is a formal document that attests to ESN-364's compliance with ESN-364 specifications and serves as a tool for batch-level quality control.
ESN-364 CoA mostly includes findings from lab analyses of a specific batch. For each ESN-364 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.
ESN-364 may be tested according to a variety of international standards, such as European Pharmacopoeia (ESN-364 EP), ESN-364 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ESN-364 USP).
