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