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