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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, unspecified form manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azithromycin, unspecified form, including repackagers and relabelers. The FDA regulates Azithromycin, unspecified form manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azithromycin, unspecified form 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, unspecified form manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azithromycin, unspecified form supplier is an individual or a company that provides Azithromycin, unspecified form active pharmaceutical ingredient (API) or Azithromycin, unspecified form finished formulations upon request. The Azithromycin, unspecified form suppliers may include Azithromycin, unspecified form API manufacturers, exporters, distributors and traders.
click here to find a list of Azithromycin, unspecified form suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azithromycin, unspecified form DMF (Drug Master File) is a document detailing the whole manufacturing process of Azithromycin, unspecified form active pharmaceutical ingredient (API) in detail. Different forms of Azithromycin, unspecified form DMFs exist exist since differing nations have different regulations, such as Azithromycin, unspecified form USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azithromycin, unspecified form DMF submitted to regulatory agencies in the US is known as a USDMF. Azithromycin, unspecified form USDMF includes data on Azithromycin, unspecified form's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azithromycin, unspecified form USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azithromycin, unspecified form 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 Azithromycin, unspecified form Drug Master File in Japan (Azithromycin, unspecified form JDMF) empowers Azithromycin, unspecified form 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, unspecified form JDMF during the approval evaluation for pharmaceutical products. At the time of Azithromycin, unspecified form 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 Azithromycin, unspecified form suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Azithromycin, unspecified form Drug Master File in Korea (Azithromycin, unspecified form KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azithromycin, unspecified form. The MFDS reviews the Azithromycin, unspecified form KDMF as part of the drug registration process and uses the information provided in the Azithromycin, unspecified form KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azithromycin, unspecified form 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, unspecified form API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Azithromycin, unspecified form suppliers with KDMF on PharmaCompass.
A Azithromycin, unspecified form CEP of the European Pharmacopoeia monograph is often referred to as a Azithromycin, unspecified form Certificate of Suitability (COS). The purpose of a Azithromycin, unspecified form CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Azithromycin, unspecified form EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Azithromycin, unspecified form to their clients by showing that a Azithromycin, unspecified form CEP has been issued for it. The manufacturer submits a Azithromycin, unspecified form CEP (COS) as part of the market authorization procedure, and it takes on the role of a Azithromycin, unspecified form CEP holder for the record. Additionally, the data presented in the Azithromycin, unspecified form CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Azithromycin, unspecified form DMF.
A Azithromycin, unspecified form CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Azithromycin, unspecified form CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Azithromycin, unspecified form suppliers with CEP (COS) on PharmaCompass.
A Azithromycin, unspecified form written confirmation (Azithromycin, unspecified form WC) is an official document issued by a regulatory agency to a Azithromycin, unspecified form manufacturer, verifying that the manufacturing facility of a Azithromycin, unspecified form active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azithromycin, unspecified form APIs or Azithromycin, unspecified form finished pharmaceutical products to another nation, regulatory agencies frequently require a Azithromycin, unspecified form WC (written confirmation) as part of the regulatory process.
click here to find a list of Azithromycin, unspecified form 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 Azithromycin, unspecified form as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azithromycin, unspecified form 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, unspecified form 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, unspecified form and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azithromycin, unspecified form NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azithromycin, unspecified form suppliers with NDC on PharmaCompass.
Azithromycin, unspecified form 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, unspecified form 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, unspecified form GMP manufacturer or Azithromycin, unspecified form GMP API supplier for your needs.
A Azithromycin, unspecified form CoA (Certificate of Analysis) is a formal document that attests to Azithromycin, unspecified form's compliance with Azithromycin, unspecified form specifications and serves as a tool for batch-level quality control.
Azithromycin, unspecified form CoA mostly includes findings from lab analyses of a specific batch. For each Azithromycin, unspecified form 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, unspecified form may be tested according to a variety of international standards, such as European Pharmacopoeia (Azithromycin, unspecified form EP), Azithromycin, unspecified form JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azithromycin, unspecified form USP).
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