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Patent Expiration Date : 2024-11-04
Date Granted : 2010-01-19
Brand Name : SANCTURA XR
Patent Number : 2537103
Filing Date : 2004-11-04
Strength per Unit : 60 mg
Dosage Form : Extended Release Capsule
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2024-11-04
Date Granted : 2010-01-19
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ABOUT THIS PAGE
A Trospium Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trospium Chloride, including repackagers and relabelers. The FDA regulates Trospium Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trospium Chloride 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 Trospium Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trospium Chloride supplier is an individual or a company that provides Trospium Chloride active pharmaceutical ingredient (API) or Trospium Chloride finished formulations upon request. The Trospium Chloride suppliers may include Trospium Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Trospium Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trospium Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Trospium Chloride active pharmaceutical ingredient (API) in detail. Different forms of Trospium Chloride DMFs exist exist since differing nations have different regulations, such as Trospium Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trospium Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Trospium Chloride USDMF includes data on Trospium Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trospium Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trospium Chloride suppliers with USDMF on PharmaCompass.
A Trospium Chloride CEP of the European Pharmacopoeia monograph is often referred to as a Trospium Chloride Certificate of Suitability (COS). The purpose of a Trospium Chloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trospium Chloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trospium Chloride to their clients by showing that a Trospium Chloride CEP has been issued for it. The manufacturer submits a Trospium Chloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trospium Chloride CEP holder for the record. Additionally, the data presented in the Trospium Chloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trospium Chloride DMF.
A Trospium Chloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trospium Chloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Trospium Chloride suppliers with CEP (COS) on PharmaCompass.
A Trospium Chloride written confirmation (Trospium Chloride WC) is an official document issued by a regulatory agency to a Trospium Chloride manufacturer, verifying that the manufacturing facility of a Trospium Chloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trospium Chloride APIs or Trospium Chloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Trospium Chloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Trospium Chloride 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 Trospium Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trospium Chloride 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 Trospium Chloride 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 Trospium Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trospium Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trospium Chloride suppliers with NDC on PharmaCompass.
Trospium Chloride 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 Trospium Chloride 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 Trospium Chloride GMP manufacturer or Trospium Chloride GMP API supplier for your needs.
A Trospium Chloride CoA (Certificate of Analysis) is a formal document that attests to Trospium Chloride's compliance with Trospium Chloride specifications and serves as a tool for batch-level quality control.
Trospium Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Trospium Chloride 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.
Trospium Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Trospium Chloride EP), Trospium Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trospium Chloride USP).
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