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