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