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ABOUT THIS PAGE
A Nitric Oxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitric Oxide, including repackagers and relabelers. The FDA regulates Nitric Oxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitric Oxide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Nitric Oxide supplier is an individual or a company that provides Nitric Oxide active pharmaceutical ingredient (API) or Nitric Oxide finished formulations upon request. The Nitric Oxide suppliers may include Nitric Oxide API manufacturers, exporters, distributors and traders.
click here to find a list of Nitric Oxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nitric Oxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitric Oxide active pharmaceutical ingredient (API) in detail. Different forms of Nitric Oxide DMFs exist exist since differing nations have different regulations, such as Nitric Oxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitric Oxide DMF submitted to regulatory agencies in the US is known as a USDMF. Nitric Oxide USDMF includes data on Nitric Oxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitric Oxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitric Oxide suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Nitric Oxide Drug Master File in Korea (Nitric Oxide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nitric Oxide. The MFDS reviews the Nitric Oxide KDMF as part of the drug registration process and uses the information provided in the Nitric Oxide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nitric Oxide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Nitric Oxide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nitric Oxide suppliers with KDMF on PharmaCompass.
A Nitric Oxide CEP of the European Pharmacopoeia monograph is often referred to as a Nitric Oxide Certificate of Suitability (COS). The purpose of a Nitric Oxide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nitric Oxide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nitric Oxide to their clients by showing that a Nitric Oxide CEP has been issued for it. The manufacturer submits a Nitric Oxide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nitric Oxide CEP holder for the record. Additionally, the data presented in the Nitric Oxide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nitric Oxide DMF.
A Nitric Oxide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nitric Oxide 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 Nitric Oxide suppliers with CEP (COS) on PharmaCompass.
Nitric Oxide 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 Nitric Oxide 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 Nitric Oxide GMP manufacturer or Nitric Oxide GMP API supplier for your needs.
A Nitric Oxide CoA (Certificate of Analysis) is a formal document that attests to Nitric Oxide's compliance with Nitric Oxide specifications and serves as a tool for batch-level quality control.
Nitric Oxide CoA mostly includes findings from lab analyses of a specific batch. For each Nitric Oxide 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.
Nitric Oxide may be tested according to a variety of international standards, such as European Pharmacopoeia (Nitric Oxide EP), Nitric Oxide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nitric Oxide USP).
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