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