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