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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 AM20050439 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AM20050439, including repackagers and relabelers. The FDA regulates AM20050439 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AM20050439 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 AM20050439 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AM20050439 supplier is an individual or a company that provides AM20050439 active pharmaceutical ingredient (API) or AM20050439 finished formulations upon request. The AM20050439 suppliers may include AM20050439 API manufacturers, exporters, distributors and traders.
click here to find a list of AM20050439 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AM20050439 DMF (Drug Master File) is a document detailing the whole manufacturing process of AM20050439 active pharmaceutical ingredient (API) in detail. Different forms of AM20050439 DMFs exist exist since differing nations have different regulations, such as AM20050439 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AM20050439 DMF submitted to regulatory agencies in the US is known as a USDMF. AM20050439 USDMF includes data on AM20050439's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AM20050439 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 AM20050439 Drug Master File in Japan (AM20050439 JDMF) empowers AM20050439 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 AM20050439 JDMF during the approval evaluation for pharmaceutical products. At the time of AM20050439 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 AM20050439 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 AM20050439 Drug Master File in Korea (AM20050439 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AM20050439. The MFDS reviews the AM20050439 KDMF as part of the drug registration process and uses the information provided in the AM20050439 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AM20050439 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 AM20050439 API can apply through the Korea Drug Master File (KDMF).
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A AM20050439 written confirmation (AM20050439 WC) is an official document issued by a regulatory agency to a AM20050439 manufacturer, verifying that the manufacturing facility of a AM20050439 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AM20050439 APIs or AM20050439 finished pharmaceutical products to another nation, regulatory agencies frequently require a AM20050439 WC (written confirmation) as part of the regulatory process.
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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 AM20050439 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AM20050439 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 AM20050439 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 AM20050439 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AM20050439 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AM20050439 suppliers with NDC on PharmaCompass.
AM20050439 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 AM20050439 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 AM20050439 GMP manufacturer or AM20050439 GMP API supplier for your needs.
A AM20050439 CoA (Certificate of Analysis) is a formal document that attests to AM20050439's compliance with AM20050439 specifications and serves as a tool for batch-level quality control.
AM20050439 CoA mostly includes findings from lab analyses of a specific batch. For each AM20050439 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.
AM20050439 may be tested according to a variety of international standards, such as European Pharmacopoeia (AM20050439 EP), AM20050439 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AM20050439 USP).
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