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USDMF
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DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 2.5GM/VIAL
USFDA APPLICATION NUMBER - 11559
DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL
USFDA APPLICATION NUMBER - 11559
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ABOUT THIS PAGE
A Methohexital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methohexital, including repackagers and relabelers. The FDA regulates Methohexital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methohexital 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 Methohexital manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methohexital supplier is an individual or a company that provides Methohexital active pharmaceutical ingredient (API) or Methohexital finished formulations upon request. The Methohexital suppliers may include Methohexital API manufacturers, exporters, distributors and traders.
click here to find a list of Methohexital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methohexital DMF (Drug Master File) is a document detailing the whole manufacturing process of Methohexital active pharmaceutical ingredient (API) in detail. Different forms of Methohexital DMFs exist exist since differing nations have different regulations, such as Methohexital USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methohexital DMF submitted to regulatory agencies in the US is known as a USDMF. Methohexital USDMF includes data on Methohexital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methohexital USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methohexital suppliers with USDMF on PharmaCompass.
A Methohexital written confirmation (Methohexital WC) is an official document issued by a regulatory agency to a Methohexital manufacturer, verifying that the manufacturing facility of a Methohexital active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Methohexital APIs or Methohexital finished pharmaceutical products to another nation, regulatory agencies frequently require a Methohexital WC (written confirmation) as part of the regulatory process.
click here to find a list of Methohexital suppliers with Written Confirmation (WC) 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 Methohexital as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methohexital 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 Methohexital 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 Methohexital and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methohexital NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methohexital suppliers with NDC on PharmaCompass.
Methohexital 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 Methohexital 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 Methohexital GMP manufacturer or Methohexital GMP API supplier for your needs.
A Methohexital CoA (Certificate of Analysis) is a formal document that attests to Methohexital's compliance with Methohexital specifications and serves as a tool for batch-level quality control.
Methohexital CoA mostly includes findings from lab analyses of a specific batch. For each Methohexital 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.
Methohexital may be tested according to a variety of international standards, such as European Pharmacopoeia (Methohexital EP), Methohexital JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methohexital USP).
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