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