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