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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Jai Radhe Sales is your partner for all your sourcing needs.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
CEP/COS
JDMF
NDC
KDMF
CN
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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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, 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.
A Orfiril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orfiril, including repackagers and relabelers. The FDA regulates Orfiril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orfiril 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 Orfiril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orfiril supplier is an individual or a company that provides Orfiril active pharmaceutical ingredient (API) or Orfiril finished formulations upon request. The Orfiril suppliers may include Orfiril API manufacturers, exporters, distributors and traders.
click here to find a list of Orfiril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orfiril DMF (Drug Master File) is a document detailing the whole manufacturing process of Orfiril active pharmaceutical ingredient (API) in detail. Different forms of Orfiril DMFs exist exist since differing nations have different regulations, such as Orfiril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orfiril DMF submitted to regulatory agencies in the US is known as a USDMF. Orfiril USDMF includes data on Orfiril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orfiril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orfiril 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 Orfiril Drug Master File in Japan (Orfiril JDMF) empowers Orfiril 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 Orfiril JDMF during the approval evaluation for pharmaceutical products. At the time of Orfiril 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 Orfiril 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 Orfiril Drug Master File in Korea (Orfiril KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Orfiril. The MFDS reviews the Orfiril KDMF as part of the drug registration process and uses the information provided in the Orfiril KDMF to evaluate the safety and efficacy of the drug.
After submitting a Orfiril 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 Orfiril API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Orfiril suppliers with KDMF on PharmaCompass.
A Orfiril CEP of the European Pharmacopoeia monograph is often referred to as a Orfiril Certificate of Suitability (COS). The purpose of a Orfiril CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orfiril EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orfiril to their clients by showing that a Orfiril CEP has been issued for it. The manufacturer submits a Orfiril CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orfiril CEP holder for the record. Additionally, the data presented in the Orfiril CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orfiril DMF.
A Orfiril CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orfiril 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 Orfiril suppliers with CEP (COS) on PharmaCompass.
A Orfiril written confirmation (Orfiril WC) is an official document issued by a regulatory agency to a Orfiril manufacturer, verifying that the manufacturing facility of a Orfiril active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Orfiril APIs or Orfiril finished pharmaceutical products to another nation, regulatory agencies frequently require a Orfiril WC (written confirmation) as part of the regulatory process.
click here to find a list of Orfiril 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 Orfiril as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Orfiril 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 Orfiril 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 Orfiril and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orfiril NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Orfiril suppliers with NDC on PharmaCompass.
Orfiril 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 Orfiril 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 Orfiril GMP manufacturer or Orfiril GMP API supplier for your needs.
A Orfiril CoA (Certificate of Analysis) is a formal document that attests to Orfiril's compliance with Orfiril specifications and serves as a tool for batch-level quality control.
Orfiril CoA mostly includes findings from lab analyses of a specific batch. For each Orfiril 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.
Orfiril may be tested according to a variety of international standards, such as European Pharmacopoeia (Orfiril EP), Orfiril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orfiril USP).
