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PharmaCompass offers a list of Lutetium-177 Vipivotide Tetraxetan 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 Vipivotide Tetraxetan manufacturer or Lutetium-177 Vipivotide Tetraxetan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lutetium-177 Vipivotide Tetraxetan manufacturer or Lutetium-177 Vipivotide Tetraxetan supplier.
PharmaCompass also assists you with knowing the Lutetium-177 Vipivotide Tetraxetan API Price utilized in the formulation of products. Lutetium-177 Vipivotide Tetraxetan API Price is not always fixed or binding as the Lutetium-177 Vipivotide Tetraxetan Price is obtained through a variety of data sources. The Lutetium-177 Vipivotide Tetraxetan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Psma-617 LU-177 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Psma-617 LU-177, including repackagers and relabelers. The FDA regulates Psma-617 LU-177 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Psma-617 LU-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 Psma-617 LU-177 supplier is an individual or a company that provides Psma-617 LU-177 active pharmaceutical ingredient (API) or Psma-617 LU-177 finished formulations upon request. The Psma-617 LU-177 suppliers may include Psma-617 LU-177 API manufacturers, exporters, distributors and traders.
click here to find a list of Psma-617 LU-177 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Psma-617 LU-177 DMF (Drug Master File) is a document detailing the whole manufacturing process of Psma-617 LU-177 active pharmaceutical ingredient (API) in detail. Different forms of Psma-617 LU-177 DMFs exist exist since differing nations have different regulations, such as Psma-617 LU-177 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Psma-617 LU-177 DMF submitted to regulatory agencies in the US is known as a USDMF. Psma-617 LU-177 USDMF includes data on Psma-617 LU-177's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Psma-617 LU-177 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Psma-617 LU-177 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 Psma-617 LU-177 Drug Master File in Japan (Psma-617 LU-177 JDMF) empowers Psma-617 LU-177 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 Psma-617 LU-177 JDMF during the approval evaluation for pharmaceutical products. At the time of Psma-617 LU-177 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 Psma-617 LU-177 suppliers with JDMF 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 Psma-617 LU-177 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Psma-617 LU-177 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 Psma-617 LU-177 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 Psma-617 LU-177 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Psma-617 LU-177 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Psma-617 LU-177 suppliers with NDC on PharmaCompass.
Psma-617 LU-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 Psma-617 LU-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 Psma-617 LU-177 GMP manufacturer or Psma-617 LU-177 GMP API supplier for your needs.
A Psma-617 LU-177 CoA (Certificate of Analysis) is a formal document that attests to Psma-617 LU-177's compliance with Psma-617 LU-177 specifications and serves as a tool for batch-level quality control.
Psma-617 LU-177 CoA mostly includes findings from lab analyses of a specific batch. For each Psma-617 LU-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.
Psma-617 LU-177 may be tested according to a variety of international standards, such as European Pharmacopoeia (Psma-617 LU-177 EP), Psma-617 LU-177 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Psma-617 LU-177 USP).
