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ABOUT THIS PAGE
A Pentamidine Isethionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentamidine Isethionate, including repackagers and relabelers. The FDA regulates Pentamidine Isethionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentamidine Isethionate 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 Pentamidine Isethionate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentamidine Isethionate supplier is an individual or a company that provides Pentamidine Isethionate active pharmaceutical ingredient (API) or Pentamidine Isethionate finished formulations upon request. The Pentamidine Isethionate suppliers may include Pentamidine Isethionate API manufacturers, exporters, distributors and traders.
click here to find a list of Pentamidine Isethionate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentamidine Isethionate DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentamidine Isethionate active pharmaceutical ingredient (API) in detail. Different forms of Pentamidine Isethionate DMFs exist exist since differing nations have different regulations, such as Pentamidine Isethionate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentamidine Isethionate DMF submitted to regulatory agencies in the US is known as a USDMF. Pentamidine Isethionate USDMF includes data on Pentamidine Isethionate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentamidine Isethionate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentamidine Isethionate suppliers with USDMF on PharmaCompass.
A Pentamidine Isethionate CEP of the European Pharmacopoeia monograph is often referred to as a Pentamidine Isethionate Certificate of Suitability (COS). The purpose of a Pentamidine Isethionate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pentamidine Isethionate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pentamidine Isethionate to their clients by showing that a Pentamidine Isethionate CEP has been issued for it. The manufacturer submits a Pentamidine Isethionate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pentamidine Isethionate CEP holder for the record. Additionally, the data presented in the Pentamidine Isethionate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pentamidine Isethionate DMF.
A Pentamidine Isethionate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pentamidine Isethionate 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 Pentamidine Isethionate suppliers with CEP (COS) 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 Pentamidine Isethionate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pentamidine Isethionate 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 Pentamidine Isethionate 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 Pentamidine Isethionate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pentamidine Isethionate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pentamidine Isethionate suppliers with NDC on PharmaCompass.
Pentamidine Isethionate 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 Pentamidine Isethionate 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 Pentamidine Isethionate GMP manufacturer or Pentamidine Isethionate GMP API supplier for your needs.
A Pentamidine Isethionate CoA (Certificate of Analysis) is a formal document that attests to Pentamidine Isethionate's compliance with Pentamidine Isethionate specifications and serves as a tool for batch-level quality control.
Pentamidine Isethionate CoA mostly includes findings from lab analyses of a specific batch. For each Pentamidine Isethionate 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.
Pentamidine Isethionate may be tested according to a variety of international standards, such as European Pharmacopoeia (Pentamidine Isethionate EP), Pentamidine Isethionate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pentamidine Isethionate USP).
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