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PharmaCompass offers a list of Lutetium-177 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 Lutetium-177 manufacturer or Lutetium-177 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lutetium-177 manufacturer or Lutetium-177 supplier.
PharmaCompass also assists you with knowing the Lutetium-177 API Price utilized in the formulation of products. Lutetium-177 API Price is not always fixed or binding as the Lutetium-177 Price is obtained through a variety of data sources. The Lutetium-177 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 177Lu manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 177Lu, including repackagers and relabelers. The FDA regulates 177Lu manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 177Lu API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 177Lu supplier is an individual or a company that provides 177Lu active pharmaceutical ingredient (API) or 177Lu finished formulations upon request. The 177Lu suppliers may include 177Lu API manufacturers, exporters, distributors and traders.
click here to find a list of 177Lu suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 177Lu DMF (Drug Master File) is a document detailing the whole manufacturing process of 177Lu active pharmaceutical ingredient (API) in detail. Different forms of 177Lu DMFs exist exist since differing nations have different regulations, such as 177Lu USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 177Lu DMF submitted to regulatory agencies in the US is known as a USDMF. 177Lu USDMF includes data on 177Lu's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 177Lu USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 177Lu suppliers with USDMF on PharmaCompass.
177Lu 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 177Lu 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 177Lu GMP manufacturer or 177Lu GMP API supplier for your needs.
A 177Lu CoA (Certificate of Analysis) is a formal document that attests to 177Lu's compliance with 177Lu specifications and serves as a tool for batch-level quality control.
177Lu CoA mostly includes findings from lab analyses of a specific batch. For each 177Lu 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.
177Lu may be tested according to a variety of international standards, such as European Pharmacopoeia (177Lu EP), 177Lu JP (Japanese Pharmacopeia) and the US Pharmacopoeia (177Lu USP).
