Close
4

Athena Athena

X

Find Divalproex Sodium manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

Other Certificates

Other Certificates

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
36
INTERMEDIATES

0

DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

South Africa

South Africa

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

Annual Reports

EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

0

USFDA Exclusivities

0

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

JP

0

Other Listed Suppliers

SERVICES
left grey arrow
right gray arrow
  • CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID
  • TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID
  • TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID
  • CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID
  • TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID
  • TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

Looking for 76584-70-8 / Divalproex Sodium API manufacturers, exporters & distributors?

Divalproex Sodium manufacturers, exporters & distributors 1

67

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

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

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

API | Excipient name

Divalproex Sodium

Synonyms

76584-70-8, Valproate semisodium, Epival, Depakote, Sodium divalproate, Semisodium valproate

Cas Number

76584-70-8

About Divalproex Sodium

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.

Divalproex Sodium Manufacturers

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

Divalproex Sodium Suppliers

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

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

Divalproex Sodium USDMF

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

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

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

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

Divalproex Sodium KDMF

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

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

After submitting a Divalproex Sodium 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 Divalproex Sodium API can apply through the Korea Drug Master File (KDMF).

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

Divalproex Sodium CEP

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

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

Divalproex Sodium WC

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

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

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

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Divalproex Sodium 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 Divalproex 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.

Compounded drug products

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

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

Divalproex Sodium GMP

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

Divalproex Sodium CoA

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

Divalproex Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Divalproex 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.

Divalproex Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Divalproex Sodium EP), Divalproex Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Divalproex Sodium 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY