Synopsis
0
API Suppliers
0
USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
Listed Suppliers
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Market Place
ABOUT THIS PAGE
A Tesofensine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tesofensine, including repackagers and relabelers. The FDA regulates Tesofensine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tesofensine 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 Tesofensine supplier is an individual or a company that provides Tesofensine active pharmaceutical ingredient (API) or Tesofensine finished formulations upon request. The Tesofensine suppliers may include Tesofensine API manufacturers, exporters, distributors and traders.
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 Tesofensine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tesofensine 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 Tesofensine 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 Tesofensine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tesofensine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tesofensine suppliers with NDC on PharmaCompass.
Tesofensine 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 Tesofensine 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 Tesofensine GMP manufacturer or Tesofensine GMP API supplier for your needs.
A Tesofensine CoA (Certificate of Analysis) is a formal document that attests to Tesofensine's compliance with Tesofensine specifications and serves as a tool for batch-level quality control.
Tesofensine CoA mostly includes findings from lab analyses of a specific batch. For each Tesofensine 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.
Tesofensine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tesofensine EP), Tesofensine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tesofensine USP).
LOOKING FOR A SUPPLIER?
Comment (6)
