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