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PharmaCompass offers a list of Halothane 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 Halothane manufacturer or Halothane supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Halothane manufacturer or Halothane supplier.
PharmaCompass also assists you with knowing the Halothane API Price utilized in the formulation of products. Halothane API Price is not always fixed or binding as the Halothane Price is obtained through a variety of data sources. The Halothane Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Halothane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Halothane, including repackagers and relabelers. The FDA regulates Halothane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Halothane 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 Halothane supplier is an individual or a company that provides Halothane active pharmaceutical ingredient (API) or Halothane finished formulations upon request. The Halothane suppliers may include Halothane API manufacturers, exporters, distributors and traders.
click here to find a list of Halothane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Halothane DMF (Drug Master File) is a document detailing the whole manufacturing process of Halothane active pharmaceutical ingredient (API) in detail. Different forms of Halothane DMFs exist exist since differing nations have different regulations, such as Halothane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Halothane DMF submitted to regulatory agencies in the US is known as a USDMF. Halothane USDMF includes data on Halothane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Halothane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Halothane suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Halothane Drug Master File in Japan (Halothane JDMF) empowers Halothane API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Halothane JDMF during the approval evaluation for pharmaceutical products. At the time of Halothane JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Halothane suppliers with JDMF on PharmaCompass.
A Halothane written confirmation (Halothane WC) is an official document issued by a regulatory agency to a Halothane manufacturer, verifying that the manufacturing facility of a Halothane active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Halothane APIs or Halothane finished pharmaceutical products to another nation, regulatory agencies frequently require a Halothane WC (written confirmation) as part of the regulatory process.
click here to find a list of Halothane suppliers with Written Confirmation (WC) on PharmaCompass.
Halothane 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 Halothane 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 Halothane GMP manufacturer or Halothane GMP API supplier for your needs.
A Halothane CoA (Certificate of Analysis) is a formal document that attests to Halothane's compliance with Halothane specifications and serves as a tool for batch-level quality control.
Halothane CoA mostly includes findings from lab analyses of a specific batch. For each Halothane 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.
Halothane may be tested according to a variety of international standards, such as European Pharmacopoeia (Halothane EP), Halothane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Halothane USP).