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