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