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PharmaCompass offers a list of Helium 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 Helium manufacturer or Helium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Helium manufacturer or Helium supplier.
PharmaCompass also assists you with knowing the Helium API Price utilized in the formulation of products. Helium API Price is not always fixed or binding as the Helium Price is obtained through a variety of data sources. The Helium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Helium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Helium, including repackagers and relabelers. The FDA regulates Helium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Helium 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 Helium supplier is an individual or a company that provides Helium active pharmaceutical ingredient (API) or Helium finished formulations upon request. The Helium suppliers may include Helium API manufacturers, exporters, distributors and traders.
Helium 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 Helium 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 Helium GMP manufacturer or Helium GMP API supplier for your needs.
A Helium CoA (Certificate of Analysis) is a formal document that attests to Helium's compliance with Helium specifications and serves as a tool for batch-level quality control.
Helium CoA mostly includes findings from lab analyses of a specific batch. For each Helium 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.
Helium may be tested according to a variety of international standards, such as European Pharmacopoeia (Helium EP), Helium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Helium USP).
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