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PharmaCompass offers a list of Oxygen API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Oxygen manufacturer or Oxygen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxygen manufacturer or Oxygen supplier.
PharmaCompass also assists you with knowing the Oxygen API Price utilized in the formulation of products. Oxygen API Price is not always fixed or binding as the Oxygen Price is obtained through a variety of data sources. The Oxygen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oxygen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxygen, including repackagers and relabelers. The FDA regulates Oxygen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxygen 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 Oxygen supplier is an individual or a company that provides Oxygen active pharmaceutical ingredient (API) or Oxygen finished formulations upon request. The Oxygen suppliers may include Oxygen API manufacturers, exporters, distributors and traders.
click here to find a list of Oxygen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxygen DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxygen active pharmaceutical ingredient (API) in detail. Different forms of Oxygen DMFs exist exist since differing nations have different regulations, such as Oxygen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxygen DMF submitted to regulatory agencies in the US is known as a USDMF. Oxygen USDMF includes data on Oxygen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxygen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxygen suppliers with USDMF on PharmaCompass.
A Oxygen CEP of the European Pharmacopoeia monograph is often referred to as a Oxygen Certificate of Suitability (COS). The purpose of a Oxygen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxygen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxygen to their clients by showing that a Oxygen CEP has been issued for it. The manufacturer submits a Oxygen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxygen CEP holder for the record. Additionally, the data presented in the Oxygen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxygen DMF.
A Oxygen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxygen 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 Oxygen suppliers with CEP (COS) on PharmaCompass.
Oxygen 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 Oxygen 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 Oxygen GMP manufacturer or Oxygen GMP API supplier for your needs.
A Oxygen CoA (Certificate of Analysis) is a formal document that attests to Oxygen's compliance with Oxygen specifications and serves as a tool for batch-level quality control.
Oxygen CoA mostly includes findings from lab analyses of a specific batch. For each Oxygen 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.
Oxygen may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxygen EP), Oxygen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxygen USP).