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Australia
DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
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USDMF
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-25
Pay. Date : 2019-09-18
DMF Number : 33350
Submission : 2019-09-24
Status :
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Sodium Valproate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sodium Valproate is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 21, 2018
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Regulatory FDF Prices
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Main Therapeutic Indication : CNS & Anesthesia
Currency : USD
2019 Revenue in Millions : 519
2018 Revenue in Millions : 493
Growth (%) : 5
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FDF DOSSIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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, 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.
A Natrium valproat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Natrium valproat, including repackagers and relabelers. The FDA regulates Natrium valproat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Natrium valproat 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 Natrium valproat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Natrium valproat supplier is an individual or a company that provides Natrium valproat active pharmaceutical ingredient (API) or Natrium valproat finished formulations upon request. The Natrium valproat suppliers may include Natrium valproat API manufacturers, exporters, distributors and traders.
click here to find a list of Natrium valproat suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Natrium valproat DMF (Drug Master File) is a document detailing the whole manufacturing process of Natrium valproat active pharmaceutical ingredient (API) in detail. Different forms of Natrium valproat DMFs exist exist since differing nations have different regulations, such as Natrium valproat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Natrium valproat DMF submitted to regulatory agencies in the US is known as a USDMF. Natrium valproat USDMF includes data on Natrium valproat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Natrium valproat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Natrium valproat 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 Natrium valproat Drug Master File in Japan (Natrium valproat JDMF) empowers Natrium valproat 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 Natrium valproat JDMF during the approval evaluation for pharmaceutical products. At the time of Natrium valproat 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 Natrium valproat 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 Natrium valproat Drug Master File in Korea (Natrium valproat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Natrium valproat. The MFDS reviews the Natrium valproat KDMF as part of the drug registration process and uses the information provided in the Natrium valproat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Natrium valproat 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 Natrium valproat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Natrium valproat suppliers with KDMF on PharmaCompass.
A Natrium valproat CEP of the European Pharmacopoeia monograph is often referred to as a Natrium valproat Certificate of Suitability (COS). The purpose of a Natrium valproat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Natrium valproat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Natrium valproat to their clients by showing that a Natrium valproat CEP has been issued for it. The manufacturer submits a Natrium valproat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Natrium valproat CEP holder for the record. Additionally, the data presented in the Natrium valproat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Natrium valproat DMF.
A Natrium valproat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Natrium valproat 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 Natrium valproat suppliers with CEP (COS) on PharmaCompass.
A Natrium valproat written confirmation (Natrium valproat WC) is an official document issued by a regulatory agency to a Natrium valproat manufacturer, verifying that the manufacturing facility of a Natrium valproat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Natrium valproat APIs or Natrium valproat finished pharmaceutical products to another nation, regulatory agencies frequently require a Natrium valproat WC (written confirmation) as part of the regulatory process.
click here to find a list of Natrium valproat 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 Natrium valproat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Natrium valproat 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 Natrium valproat 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 Natrium valproat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Natrium valproat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Natrium valproat suppliers with NDC on PharmaCompass.
Natrium valproat 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 Natrium valproat GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Natrium valproat GMP manufacturer or Natrium valproat GMP API supplier for your needs.
A Natrium valproat CoA (Certificate of Analysis) is a formal document that attests to Natrium valproat's compliance with Natrium valproat specifications and serves as a tool for batch-level quality control.
Natrium valproat CoA mostly includes findings from lab analyses of a specific batch. For each Natrium valproat 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.
Natrium valproat may be tested according to a variety of international standards, such as European Pharmacopoeia (Natrium valproat EP), Natrium valproat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Natrium valproat USP).
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