API Suppliers
US DMFs Filed
CEP/COS Certifications
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JDMFs Filed
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EU WC
Listed Suppliers
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USA (Orange Book)
Europe
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Australia
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South Africa
Uploaded Dossiers
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U.S. Medicaid
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PharmaCompass offers a list of Azelaic Acid 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 Azelaic Acid manufacturer or Azelaic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azelaic Acid manufacturer or Azelaic Acid supplier.
PharmaCompass also assists you with knowing the Azelaic Acid API Price utilized in the formulation of products. Azelaic Acid API Price is not always fixed or binding as the Azelaic Acid Price is obtained through a variety of data sources. The Azelaic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Azelaic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azelaic Acid, including repackagers and relabelers. The FDA regulates Azelaic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azelaic Acid 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 Azelaic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azelaic Acid supplier is an individual or a company that provides Azelaic Acid active pharmaceutical ingredient (API) or Azelaic Acid finished formulations upon request. The Azelaic Acid suppliers may include Azelaic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Azelaic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azelaic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Azelaic Acid active pharmaceutical ingredient (API) in detail. Different forms of Azelaic Acid DMFs exist exist since differing nations have different regulations, such as Azelaic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azelaic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Azelaic Acid USDMF includes data on Azelaic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azelaic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azelaic Acid suppliers with USDMF on PharmaCompass.
A Azelaic Acid written confirmation (Azelaic Acid WC) is an official document issued by a regulatory agency to a Azelaic Acid manufacturer, verifying that the manufacturing facility of a Azelaic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azelaic Acid APIs or Azelaic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Azelaic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Azelaic Acid 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 Azelaic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azelaic Acid 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 Azelaic Acid 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 Azelaic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azelaic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azelaic Acid suppliers with NDC on PharmaCompass.
Azelaic Acid 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 Azelaic Acid 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 Azelaic Acid GMP manufacturer or Azelaic Acid GMP API supplier for your needs.
A Azelaic Acid CoA (Certificate of Analysis) is a formal document that attests to Azelaic Acid's compliance with Azelaic Acid specifications and serves as a tool for batch-level quality control.
Azelaic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Azelaic Acid 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.
Azelaic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Azelaic Acid EP), Azelaic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azelaic Acid USP).