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