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Looking for 1069-66-5 / Sodium Valproate API manufacturers, exporters & distributors?

Sodium Valproate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sodium Valproate

Synonyms

Sodium 2-propylpentanoate, 1069-66-5, Valproate sodium, Valproic acid sodium salt, Valproic acid sodium, Depacon

Cas Number

1069-66-5

Unique Ingredient Identifier (UNII)

5VOM6GYJ0D

About Sodium Valproate

A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.

Sodium Valproate Manufacturers

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

Sodium Valproate Suppliers

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

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

Sodium Valproate USDMF

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

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

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

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

Sodium Valproate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Sodium Valproate Drug Master File in Korea (Sodium Valproate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium Valproate. The MFDS reviews the Sodium Valproate KDMF as part of the drug registration process and uses the information provided in the Sodium Valproate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Sodium Valproate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sodium Valproate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Sodium Valproate suppliers with KDMF on PharmaCompass.

Sodium Valproate CEP

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

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

Sodium Valproate WC

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

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

Sodium Valproate 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 Sodium Valproate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Sodium Valproate 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 Sodium Valproate 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 Sodium Valproate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Valproate NDC to their finished compounded human drug products, they may choose to do so.

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

Sodium Valproate GMP

Sodium Valproate 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 Valproate 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 Valproate GMP manufacturer or Sodium Valproate GMP API supplier for your needs.

Sodium Valproate CoA

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

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