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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Europe
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Canada
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Australia
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South Africa
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DRUG PRODUCT COMPOSITIONS
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FDF
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Stock Recap #PipelineProspector
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API SUPPLIERS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Axplora is your partner of choice for complex APIs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Maithri Drugs: Dedicated to your API needs.
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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 : 41470
Submission : 2025-03-11
Status :
Type : II
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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ABOUT THIS PAGE
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PharmaCompass offers a list of Zavegepant HCl API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Zavegepant HCl manufacturer or Zavegepant HCl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zavegepant HCl manufacturer or Zavegepant HCl supplier.
A Zavegepant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zavegepant, including repackagers and relabelers. The FDA regulates Zavegepant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zavegepant 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 Zavegepant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zavegepant supplier is an individual or a company that provides Zavegepant active pharmaceutical ingredient (API) or Zavegepant finished formulations upon request. The Zavegepant suppliers may include Zavegepant API manufacturers, exporters, distributors and traders.
click here to find a list of Zavegepant suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Zavegepant DMF (Drug Master File) is a document detailing the whole manufacturing process of Zavegepant active pharmaceutical ingredient (API) in detail. Different forms of Zavegepant DMFs exist exist since differing nations have different regulations, such as Zavegepant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zavegepant DMF submitted to regulatory agencies in the US is known as a USDMF. Zavegepant USDMF includes data on Zavegepant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zavegepant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zavegepant suppliers with USDMF on PharmaCompass.
A Zavegepant written confirmation (Zavegepant WC) is an official document issued by a regulatory agency to a Zavegepant manufacturer, verifying that the manufacturing facility of a Zavegepant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zavegepant APIs or Zavegepant finished pharmaceutical products to another nation, regulatory agencies frequently require a Zavegepant WC (written confirmation) as part of the regulatory process.
click here to find a list of Zavegepant 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 Zavegepant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zavegepant 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 Zavegepant 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 Zavegepant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zavegepant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zavegepant suppliers with NDC on PharmaCompass.
Zavegepant 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 Zavegepant GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Zavegepant GMP manufacturer or Zavegepant GMP API supplier for your needs.
A Zavegepant CoA (Certificate of Analysis) is a formal document that attests to Zavegepant's compliance with Zavegepant specifications and serves as a tool for batch-level quality control.
Zavegepant CoA mostly includes findings from lab analyses of a specific batch. For each Zavegepant 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.
Zavegepant may be tested according to a variety of international standards, such as European Pharmacopoeia (Zavegepant EP), Zavegepant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zavegepant USP).
Comment (5)
