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Looking for 50-06-6 / Phenobarbital API manufacturers, exporters & distributors?

Phenobarbital manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Phenobarbital 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 Phenobarbital manufacturer or Phenobarbital supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenobarbital manufacturer or Phenobarbital supplier.

PharmaCompass also assists you with knowing the Phenobarbital API Price utilized in the formulation of products. Phenobarbital API Price is not always fixed or binding as the Phenobarbital Price is obtained through a variety of data sources. The Phenobarbital Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Phenobarbital

Synonyms

Phenobarbitone, Luminal, Phenobarbitol, 50-06-6, Phenylethylbarbiturate, Phenobarbituric acid

Cas Number

50-06-6

Unique Ingredient Identifier (UNII)

YQE403BP4D

About Phenobarbital

A barbituric acid derivative that acts as a nonselective central nervous system depressant. It potentiates GAMMA-AMINOBUTYRIC ACID action on GABA-A RECEPTORS, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations.

Phenobarbital Manufacturers

A Phenobarbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenobarbital, including repackagers and relabelers. The FDA regulates Phenobarbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenobarbital 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Phenobarbital Suppliers

A Phenobarbital supplier is an individual or a company that provides Phenobarbital active pharmaceutical ingredient (API) or Phenobarbital finished formulations upon request. The Phenobarbital suppliers may include Phenobarbital API manufacturers, exporters, distributors and traders.

click here to find a list of Phenobarbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Phenobarbital USDMF

A Phenobarbital DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenobarbital active pharmaceutical ingredient (API) in detail. Different forms of Phenobarbital DMFs exist exist since differing nations have different regulations, such as Phenobarbital USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Phenobarbital DMF submitted to regulatory agencies in the US is known as a USDMF. Phenobarbital USDMF includes data on Phenobarbital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenobarbital USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Phenobarbital suppliers with USDMF on PharmaCompass.

Phenobarbital JDMF

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 Drug Master File in Japan (Phenobarbital JDMF) empowers Phenobarbital 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Phenobarbital 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 suppliers with JDMF on PharmaCompass.

Phenobarbital CEP

A Phenobarbital CEP of the European Pharmacopoeia monograph is often referred to as a Phenobarbital Certificate of Suitability (COS). The purpose of a Phenobarbital CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phenobarbital EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phenobarbital to their clients by showing that a Phenobarbital CEP has been issued for it. The manufacturer submits a Phenobarbital CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phenobarbital CEP holder for the record. Additionally, the data presented in the Phenobarbital CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phenobarbital DMF.

A Phenobarbital CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenobarbital 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 suppliers with CEP (COS) on PharmaCompass.

Phenobarbital WC

A Phenobarbital written confirmation (Phenobarbital WC) is an official document issued by a regulatory agency to a Phenobarbital manufacturer, verifying that the manufacturing facility of a Phenobarbital active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Phenobarbital APIs or Phenobarbital finished pharmaceutical products to another nation, regulatory agencies frequently require a Phenobarbital WC (written confirmation) as part of the regulatory process.

click here to find a list of Phenobarbital suppliers with Written Confirmation (WC) on PharmaCompass.

Phenobarbital NDC

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 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Phenobarbital API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Phenobarbital and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phenobarbital NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Phenobarbital suppliers with NDC on PharmaCompass.

Phenobarbital GMP

Phenobarbital 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 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 GMP manufacturer or Phenobarbital GMP API supplier for your needs.

Phenobarbital CoA

A Phenobarbital CoA (Certificate of Analysis) is a formal document that attests to Phenobarbital's compliance with Phenobarbital specifications and serves as a tool for batch-level quality control.

Phenobarbital CoA mostly includes findings from lab analyses of a specific batch. For each Phenobarbital 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Phenobarbital EP), Phenobarbital JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phenobarbital USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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