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