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