US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Solifenacin Succinate 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 Solifenacin Succinate manufacturer or Solifenacin Succinate supplier for your needs.
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PharmaCompass also assists you with knowing the Solifenacin Succinate API Price utilized in the formulation of products. Solifenacin Succinate API Price is not always fixed or binding as the Solifenacin Succinate Price is obtained through a variety of data sources. The Solifenacin Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Solifenacin Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solifenacin Succinate, including repackagers and relabelers. The FDA regulates Solifenacin Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solifenacin Succinate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Solifenacin Succinate supplier is an individual or a company that provides Solifenacin Succinate active pharmaceutical ingredient (API) or Solifenacin Succinate finished formulations upon request. The Solifenacin Succinate suppliers may include Solifenacin Succinate API manufacturers, exporters, distributors and traders.
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A Solifenacin Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Solifenacin Succinate active pharmaceutical ingredient (API) in detail. Different forms of Solifenacin Succinate DMFs exist exist since differing nations have different regulations, such as Solifenacin Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Solifenacin Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Solifenacin Succinate USDMF includes data on Solifenacin Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Solifenacin Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Solifenacin Succinate Drug Master File in Japan (Solifenacin Succinate JDMF) empowers Solifenacin Succinate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Solifenacin Succinate JDMF during the approval evaluation for pharmaceutical products. At the time of Solifenacin Succinate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Solifenacin Succinate Drug Master File in Korea (Solifenacin Succinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Solifenacin Succinate. The MFDS reviews the Solifenacin Succinate KDMF as part of the drug registration process and uses the information provided in the Solifenacin Succinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Solifenacin Succinate 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 Solifenacin Succinate API can apply through the Korea Drug Master File (KDMF).
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A Solifenacin Succinate CEP of the European Pharmacopoeia monograph is often referred to as a Solifenacin Succinate Certificate of Suitability (COS). The purpose of a Solifenacin Succinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Solifenacin Succinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Solifenacin Succinate to their clients by showing that a Solifenacin Succinate CEP has been issued for it. The manufacturer submits a Solifenacin Succinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Solifenacin Succinate CEP holder for the record. Additionally, the data presented in the Solifenacin Succinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Solifenacin Succinate DMF.
A Solifenacin Succinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Solifenacin Succinate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Solifenacin Succinate written confirmation (Solifenacin Succinate WC) is an official document issued by a regulatory agency to a Solifenacin Succinate manufacturer, verifying that the manufacturing facility of a Solifenacin Succinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Solifenacin Succinate APIs or Solifenacin Succinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Solifenacin Succinate WC (written confirmation) as part of the regulatory process.
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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 Solifenacin Succinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Solifenacin Succinate 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 Solifenacin Succinate 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 Solifenacin Succinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Solifenacin Succinate NDC to their finished compounded human drug products, they may choose to do so.
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Solifenacin Succinate 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 Solifenacin Succinate 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 Solifenacin Succinate GMP manufacturer or Solifenacin Succinate GMP API supplier for your needs.
A Solifenacin Succinate CoA (Certificate of Analysis) is a formal document that attests to Solifenacin Succinate's compliance with Solifenacin Succinate specifications and serves as a tool for batch-level quality control.
Solifenacin Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Solifenacin Succinate 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.
Solifenacin Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Solifenacin Succinate EP), Solifenacin Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Solifenacin Succinate USP).