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DOSAGE - TABLET;ORAL - EQ 2MG BASE
USFDA APPLICATION NUMBER - 21200
DOSAGE - TABLET;ORAL - EQ 6MG BASE
USFDA APPLICATION NUMBER - 21200
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ABOUT THIS PAGE
A Tegaserod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tegaserod, including repackagers and relabelers. The FDA regulates Tegaserod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tegaserod 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 Tegaserod manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tegaserod supplier is an individual or a company that provides Tegaserod active pharmaceutical ingredient (API) or Tegaserod finished formulations upon request. The Tegaserod suppliers may include Tegaserod API manufacturers, exporters, distributors and traders.
click here to find a list of Tegaserod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tegaserod DMF (Drug Master File) is a document detailing the whole manufacturing process of Tegaserod active pharmaceutical ingredient (API) in detail. Different forms of Tegaserod DMFs exist exist since differing nations have different regulations, such as Tegaserod USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tegaserod DMF submitted to regulatory agencies in the US is known as a USDMF. Tegaserod USDMF includes data on Tegaserod's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tegaserod USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tegaserod suppliers with USDMF on PharmaCompass.
A Tegaserod written confirmation (Tegaserod WC) is an official document issued by a regulatory agency to a Tegaserod manufacturer, verifying that the manufacturing facility of a Tegaserod active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tegaserod APIs or Tegaserod finished pharmaceutical products to another nation, regulatory agencies frequently require a Tegaserod WC (written confirmation) as part of the regulatory process.
click here to find a list of Tegaserod 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 Tegaserod as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tegaserod 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 Tegaserod 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 Tegaserod and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tegaserod NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tegaserod suppliers with NDC on PharmaCompass.
Tegaserod 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 Tegaserod 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 Tegaserod GMP manufacturer or Tegaserod GMP API supplier for your needs.
A Tegaserod CoA (Certificate of Analysis) is a formal document that attests to Tegaserod's compliance with Tegaserod specifications and serves as a tool for batch-level quality control.
Tegaserod CoA mostly includes findings from lab analyses of a specific batch. For each Tegaserod 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.
Tegaserod may be tested according to a variety of international standards, such as European Pharmacopoeia (Tegaserod EP), Tegaserod JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tegaserod USP).
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