US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Azithromycin 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 Azithromycin manufacturer or Azithromycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azithromycin manufacturer or Azithromycin supplier.
PharmaCompass also assists you with knowing the Azithromycin API Price utilized in the formulation of products. Azithromycin API Price is not always fixed or binding as the Azithromycin Price is obtained through a variety of data sources. The Azithromycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Azithromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azithromycin, including repackagers and relabelers. The FDA regulates Azithromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azithromycin 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 Azithromycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azithromycin supplier is an individual or a company that provides Azithromycin active pharmaceutical ingredient (API) or Azithromycin finished formulations upon request. The Azithromycin suppliers may include Azithromycin API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Azithromycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azithromycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Azithromycin active pharmaceutical ingredient (API) in detail. Different forms of Azithromycin DMFs exist exist since differing nations have different regulations, such as Azithromycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azithromycin DMF submitted to regulatory agencies in the US is known as a USDMF. Azithromycin USDMF includes data on Azithromycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azithromycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Azithromycin Drug Master File in Japan (Azithromycin JDMF) empowers Azithromycin 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 Azithromycin JDMF during the approval evaluation for pharmaceutical products. At the time of Azithromycin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Azithromycin Drug Master File in Korea (Azithromycin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azithromycin. The MFDS reviews the Azithromycin KDMF as part of the drug registration process and uses the information provided in the Azithromycin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azithromycin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Azithromycin API can apply through the Korea Drug Master File (KDMF).
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A Azithromycin CEP of the European Pharmacopoeia monograph is often referred to as a Azithromycin Certificate of Suitability (COS). The purpose of a Azithromycin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Azithromycin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Azithromycin to their clients by showing that a Azithromycin CEP has been issued for it. The manufacturer submits a Azithromycin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Azithromycin CEP holder for the record. Additionally, the data presented in the Azithromycin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Azithromycin DMF.
A Azithromycin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Azithromycin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Azithromycin written confirmation (Azithromycin WC) is an official document issued by a regulatory agency to a Azithromycin manufacturer, verifying that the manufacturing facility of a Azithromycin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azithromycin APIs or Azithromycin finished pharmaceutical products to another nation, regulatory agencies frequently require a Azithromycin WC (written confirmation) as part of the regulatory process.
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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 Azithromycin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azithromycin 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 Azithromycin 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 Azithromycin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azithromycin NDC to their finished compounded human drug products, they may choose to do so.
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Azithromycin 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 Azithromycin 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 Azithromycin GMP manufacturer or Azithromycin GMP API supplier for your needs.
A Azithromycin CoA (Certificate of Analysis) is a formal document that attests to Azithromycin's compliance with Azithromycin specifications and serves as a tool for batch-level quality control.
Azithromycin CoA mostly includes findings from lab analyses of a specific batch. For each Azithromycin 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.
Azithromycin may be tested according to a variety of international standards, such as European Pharmacopoeia (Azithromycin EP), Azithromycin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azithromycin USP).