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