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DRUG PRODUCT COMPOSITIONS0
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - 250MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18081
DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Reg...DOSAGE - SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18082
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 12...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID
USFDA APPLICATION NUMBER - 18723
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 25...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID
USFDA APPLICATION NUMBER - 18723
DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 50...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID
USFDA APPLICATION NUMBER - 18723
DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID
USFDA APPLICATION NUMBER - 19680
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID
USFDA APPLICATION NUMBER - 21168
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID
USFDA APPLICATION NUMBER - 21168
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
ABOUT THIS PAGE
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.
A Depakine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Depakine, including repackagers and relabelers. The FDA regulates Depakine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Depakine 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 Depakine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Depakine supplier is an individual or a company that provides Depakine active pharmaceutical ingredient (API) or Depakine finished formulations upon request. The Depakine suppliers may include Depakine API manufacturers, exporters, distributors and traders.
click here to find a list of Depakine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Depakine DMF (Drug Master File) is a document detailing the whole manufacturing process of Depakine active pharmaceutical ingredient (API) in detail. Different forms of Depakine DMFs exist exist since differing nations have different regulations, such as Depakine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Depakine DMF submitted to regulatory agencies in the US is known as a USDMF. Depakine USDMF includes data on Depakine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Depakine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Depakine 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 Depakine Drug Master File in Japan (Depakine JDMF) empowers Depakine 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 Depakine JDMF during the approval evaluation for pharmaceutical products. At the time of Depakine 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 Depakine suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Depakine Drug Master File in Korea (Depakine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Depakine. The MFDS reviews the Depakine KDMF as part of the drug registration process and uses the information provided in the Depakine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Depakine 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 Depakine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Depakine suppliers with KDMF on PharmaCompass.
A Depakine CEP of the European Pharmacopoeia monograph is often referred to as a Depakine Certificate of Suitability (COS). The purpose of a Depakine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Depakine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Depakine to their clients by showing that a Depakine CEP has been issued for it. The manufacturer submits a Depakine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Depakine CEP holder for the record. Additionally, the data presented in the Depakine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Depakine DMF.
A Depakine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Depakine 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 Depakine suppliers with CEP (COS) on PharmaCompass.
A Depakine written confirmation (Depakine WC) is an official document issued by a regulatory agency to a Depakine manufacturer, verifying that the manufacturing facility of a Depakine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Depakine APIs or Depakine finished pharmaceutical products to another nation, regulatory agencies frequently require a Depakine WC (written confirmation) as part of the regulatory process.
click here to find a list of Depakine 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 Depakine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Depakine 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 Depakine 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 Depakine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Depakine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Depakine suppliers with NDC on PharmaCompass.
Depakine 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 Depakine 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 Depakine GMP manufacturer or Depakine GMP API supplier for your needs.
A Depakine CoA (Certificate of Analysis) is a formal document that attests to Depakine's compliance with Depakine specifications and serves as a tool for batch-level quality control.
Depakine CoA mostly includes findings from lab analyses of a specific batch. For each Depakine 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.
Depakine may be tested according to a variety of international standards, such as European Pharmacopoeia (Depakine EP), Depakine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Depakine USP).
