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