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