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API SUPPLIERS
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USDMF
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-25
Pay. Date : 2025-05-20
DMF Number : 40159
Submission : 2024-06-29
Status :
Type : II
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PharmaCompass offers a list of Avacopan 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 Avacopan manufacturer or Avacopan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Avacopan manufacturer or Avacopan supplier.
PharmaCompass also assists you with knowing the Avacopan API Price utilized in the formulation of products. Avacopan API Price is not always fixed or binding as the Avacopan Price is obtained through a variety of data sources. The Avacopan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Avacopan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avacopan, including repackagers and relabelers. The FDA regulates Avacopan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avacopan 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 Avacopan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avacopan supplier is an individual or a company that provides Avacopan active pharmaceutical ingredient (API) or Avacopan finished formulations upon request. The Avacopan suppliers may include Avacopan API manufacturers, exporters, distributors and traders.
click here to find a list of Avacopan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Avacopan DMF (Drug Master File) is a document detailing the whole manufacturing process of Avacopan active pharmaceutical ingredient (API) in detail. Different forms of Avacopan DMFs exist exist since differing nations have different regulations, such as Avacopan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avacopan DMF submitted to regulatory agencies in the US is known as a USDMF. Avacopan USDMF includes data on Avacopan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avacopan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avacopan suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Avacopan Drug Master File in Japan (Avacopan JDMF) empowers Avacopan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Avacopan JDMF during the approval evaluation for pharmaceutical products. At the time of Avacopan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Avacopan suppliers with JDMF 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 Avacopan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Avacopan 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 Avacopan 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 Avacopan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Avacopan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Avacopan suppliers with NDC on PharmaCompass.
Avacopan 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 Avacopan 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 Avacopan GMP manufacturer or Avacopan GMP API supplier for your needs.
A Avacopan CoA (Certificate of Analysis) is a formal document that attests to Avacopan's compliance with Avacopan specifications and serves as a tool for batch-level quality control.
Avacopan CoA mostly includes findings from lab analyses of a specific batch. For each Avacopan 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.
Avacopan may be tested according to a variety of international standards, such as European Pharmacopoeia (Avacopan EP), Avacopan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Avacopan USP).
