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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 21518
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 21518
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Solifenacin Succinate manufacturer or Solifenacin Succinate supplier.
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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solifenacin, including repackagers and relabelers. The FDA regulates Solifenacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solifenacin 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 Solifenacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Solifenacin supplier is an individual or a company that provides Solifenacin active pharmaceutical ingredient (API) or Solifenacin finished formulations upon request. The Solifenacin suppliers may include Solifenacin API manufacturers, exporters, distributors and traders.
click here to find a list of Solifenacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Solifenacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Solifenacin active pharmaceutical ingredient (API) in detail. Different forms of Solifenacin DMFs exist exist since differing nations have different regulations, such as Solifenacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Solifenacin DMF submitted to regulatory agencies in the US is known as a USDMF. Solifenacin USDMF includes data on Solifenacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Solifenacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Solifenacin suppliers with USDMF on PharmaCompass.
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 Drug Master File in Japan (Solifenacin JDMF) empowers Solifenacin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Solifenacin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Solifenacin suppliers with JDMF 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 Solifenacin Drug Master File in Korea (Solifenacin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Solifenacin. The MFDS reviews the Solifenacin KDMF as part of the drug registration process and uses the information provided in the Solifenacin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Solifenacin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Solifenacin suppliers with KDMF on PharmaCompass.
A Solifenacin CEP of the European Pharmacopoeia monograph is often referred to as a Solifenacin Certificate of Suitability (COS). The purpose of a Solifenacin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Solifenacin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Solifenacin to their clients by showing that a Solifenacin CEP has been issued for it. The manufacturer submits a Solifenacin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Solifenacin CEP holder for the record. Additionally, the data presented in the Solifenacin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Solifenacin DMF.
A Solifenacin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Solifenacin 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 Solifenacin suppliers with CEP (COS) on PharmaCompass.
A Solifenacin written confirmation (Solifenacin WC) is an official document issued by a regulatory agency to a Solifenacin manufacturer, verifying that the manufacturing facility of a Solifenacin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Solifenacin APIs or Solifenacin finished pharmaceutical products to another nation, regulatory agencies frequently require a Solifenacin WC (written confirmation) as part of the regulatory process.
click here to find a list of Solifenacin 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 Solifenacin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Solifenacin 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Solifenacin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Solifenacin suppliers with NDC on PharmaCompass.
Solifenacin 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 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 GMP manufacturer or Solifenacin GMP API supplier for your needs.
A Solifenacin CoA (Certificate of Analysis) is a formal document that attests to Solifenacin's compliance with Solifenacin specifications and serves as a tool for batch-level quality control.
Solifenacin CoA mostly includes findings from lab analyses of a specific batch. For each Solifenacin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Solifenacin EP), Solifenacin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Solifenacin USP).
