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