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