API Suppliers
US DMFs Filed
CEP/COS Certifications
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EU WC
Listed Suppliers
USA (Orange Book)
Europe
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Australia
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PharmaCompass offers a list of Tolterodine Tartrate 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 Tolterodine Tartrate manufacturer or Tolterodine Tartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tolterodine Tartrate manufacturer or Tolterodine Tartrate supplier.
PharmaCompass also assists you with knowing the Tolterodine Tartrate API Price utilized in the formulation of products. Tolterodine Tartrate API Price is not always fixed or binding as the Tolterodine Tartrate Price is obtained through a variety of data sources. The Tolterodine Tartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tolterodine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolterodine, including repackagers and relabelers. The FDA regulates Tolterodine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolterodine 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 Tolterodine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolterodine supplier is an individual or a company that provides Tolterodine active pharmaceutical ingredient (API) or Tolterodine finished formulations upon request. The Tolterodine suppliers may include Tolterodine API manufacturers, exporters, distributors and traders.
click here to find a list of Tolterodine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tolterodine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolterodine active pharmaceutical ingredient (API) in detail. Different forms of Tolterodine DMFs exist exist since differing nations have different regulations, such as Tolterodine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolterodine DMF submitted to regulatory agencies in the US is known as a USDMF. Tolterodine USDMF includes data on Tolterodine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolterodine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolterodine suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tolterodine Drug Master File in Korea (Tolterodine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tolterodine. The MFDS reviews the Tolterodine KDMF as part of the drug registration process and uses the information provided in the Tolterodine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tolterodine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tolterodine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tolterodine suppliers with KDMF on PharmaCompass.
A Tolterodine CEP of the European Pharmacopoeia monograph is often referred to as a Tolterodine Certificate of Suitability (COS). The purpose of a Tolterodine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tolterodine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tolterodine to their clients by showing that a Tolterodine CEP has been issued for it. The manufacturer submits a Tolterodine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tolterodine CEP holder for the record. Additionally, the data presented in the Tolterodine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tolterodine DMF.
A Tolterodine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tolterodine 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 Tolterodine suppliers with CEP (COS) on PharmaCompass.
A Tolterodine written confirmation (Tolterodine WC) is an official document issued by a regulatory agency to a Tolterodine manufacturer, verifying that the manufacturing facility of a Tolterodine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tolterodine APIs or Tolterodine finished pharmaceutical products to another nation, regulatory agencies frequently require a Tolterodine WC (written confirmation) as part of the regulatory process.
click here to find a list of Tolterodine 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 Tolterodine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tolterodine 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 Tolterodine 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 Tolterodine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tolterodine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tolterodine suppliers with NDC on PharmaCompass.
Tolterodine 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 Tolterodine 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 Tolterodine GMP manufacturer or Tolterodine GMP API supplier for your needs.
A Tolterodine CoA (Certificate of Analysis) is a formal document that attests to Tolterodine's compliance with Tolterodine specifications and serves as a tool for batch-level quality control.
Tolterodine CoA mostly includes findings from lab analyses of a specific batch. For each Tolterodine 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.
Tolterodine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tolterodine EP), Tolterodine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tolterodine USP).