Synopsis
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JDMF
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EU WC
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FDF
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FDA Orange Book
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Europe
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Australia
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DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
US Medicaid
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API SUPPLIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Pyrantel Tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pyrantel Tartrate, including repackagers and relabelers. The FDA regulates Pyrantel Tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pyrantel Tartrate 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 Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pyrantel Tartrate supplier is an individual or a company that provides Pyrantel Tartrate active pharmaceutical ingredient (API) or Pyrantel Tartrate finished formulations upon request. The Pyrantel Tartrate suppliers may include Pyrantel Tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Pyrantel Tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pyrantel Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Pyrantel Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Pyrantel Tartrate DMFs exist exist since differing nations have different regulations, such as Pyrantel Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pyrantel Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Pyrantel Tartrate USDMF includes data on Pyrantel Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pyrantel Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pyrantel Tartrate suppliers with USDMF 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 Tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pyrantel Tartrate 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 Tartrate 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 Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pyrantel Tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pyrantel Tartrate suppliers with NDC on PharmaCompass.
Pyrantel Tartrate 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 Tartrate 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 Tartrate GMP manufacturer or Pyrantel Tartrate GMP API supplier for your needs.
A Pyrantel Tartrate CoA (Certificate of Analysis) is a formal document that attests to Pyrantel Tartrate's compliance with Pyrantel Tartrate specifications and serves as a tool for batch-level quality control.
Pyrantel Tartrate CoA mostly includes findings from lab analyses of a specific batch. For each Pyrantel Tartrate 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 Tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Pyrantel Tartrate EP), Pyrantel Tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pyrantel Tartrate USP).
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