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ABOUT THIS PAGE
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PharmaCompass offers a list of Valbenazine Tosylate 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 Valbenazine Tosylate manufacturer or Valbenazine Tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Valbenazine Tosylate manufacturer or Valbenazine Tosylate supplier.
PharmaCompass also assists you with knowing the Valbenazine Tosylate API Price utilized in the formulation of products. Valbenazine Tosylate API Price is not always fixed or binding as the Valbenazine Tosylate Price is obtained through a variety of data sources. The Valbenazine Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Valbenazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valbenazine, including repackagers and relabelers. The FDA regulates Valbenazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valbenazine 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 Valbenazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valbenazine supplier is an individual or a company that provides Valbenazine active pharmaceutical ingredient (API) or Valbenazine finished formulations upon request. The Valbenazine suppliers may include Valbenazine API manufacturers, exporters, distributors and traders.
click here to find a list of Valbenazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valbenazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Valbenazine active pharmaceutical ingredient (API) in detail. Different forms of Valbenazine DMFs exist exist since differing nations have different regulations, such as Valbenazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valbenazine DMF submitted to regulatory agencies in the US is known as a USDMF. Valbenazine USDMF includes data on Valbenazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valbenazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valbenazine 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 Valbenazine Drug Master File in Korea (Valbenazine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valbenazine. The MFDS reviews the Valbenazine KDMF as part of the drug registration process and uses the information provided in the Valbenazine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valbenazine 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 Valbenazine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valbenazine suppliers with KDMF on PharmaCompass.
A Valbenazine written confirmation (Valbenazine WC) is an official document issued by a regulatory agency to a Valbenazine manufacturer, verifying that the manufacturing facility of a Valbenazine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valbenazine APIs or Valbenazine finished pharmaceutical products to another nation, regulatory agencies frequently require a Valbenazine WC (written confirmation) as part of the regulatory process.
click here to find a list of Valbenazine 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 Valbenazine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valbenazine 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 Valbenazine 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 Valbenazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valbenazine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valbenazine suppliers with NDC on PharmaCompass.
Valbenazine 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 Valbenazine 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 Valbenazine GMP manufacturer or Valbenazine GMP API supplier for your needs.
A Valbenazine CoA (Certificate of Analysis) is a formal document that attests to Valbenazine's compliance with Valbenazine specifications and serves as a tool for batch-level quality control.
Valbenazine CoA mostly includes findings from lab analyses of a specific batch. For each Valbenazine 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.
Valbenazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Valbenazine EP), Valbenazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valbenazine USP).
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