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