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ABOUT THIS PAGE
A Lutetium-177 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutetium-177, including repackagers and relabelers. The FDA regulates Lutetium-177 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutetium-177 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 Lutetium-177 supplier is an individual or a company that provides Lutetium-177 active pharmaceutical ingredient (API) or Lutetium-177 finished formulations upon request. The Lutetium-177 suppliers may include Lutetium-177 API manufacturers, exporters, distributors and traders.
click here to find a list of Lutetium-177 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lutetium-177 DMF (Drug Master File) is a document detailing the whole manufacturing process of Lutetium-177 active pharmaceutical ingredient (API) in detail. Different forms of Lutetium-177 DMFs exist exist since differing nations have different regulations, such as Lutetium-177 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lutetium-177 DMF submitted to regulatory agencies in the US is known as a USDMF. Lutetium-177 USDMF includes data on Lutetium-177's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lutetium-177 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lutetium-177 suppliers with USDMF on PharmaCompass.
Lutetium-177 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 Lutetium-177 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 Lutetium-177 GMP manufacturer or Lutetium-177 GMP API supplier for your needs.
A Lutetium-177 CoA (Certificate of Analysis) is a formal document that attests to Lutetium-177's compliance with Lutetium-177 specifications and serves as a tool for batch-level quality control.
Lutetium-177 CoA mostly includes findings from lab analyses of a specific batch. For each Lutetium-177 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.
Lutetium-177 may be tested according to a variety of international standards, such as European Pharmacopoeia (Lutetium-177 EP), Lutetium-177 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lutetium-177 USP).
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