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