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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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Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products with a focus on rapid development and cost-effective production. Its fully equipped research labs, pilot...
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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 Valproate Sodium (Depacon) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valproate Sodium (Depacon), including repackagers and relabelers. The FDA regulates Valproate Sodium (Depacon) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Valproate Sodium (Depacon) supplier is an individual or a company that provides Valproate Sodium (Depacon) active pharmaceutical ingredient (API) or Valproate Sodium (Depacon) finished formulations upon request. The Valproate Sodium (Depacon) suppliers may include Valproate Sodium (Depacon) API manufacturers, exporters, distributors and traders.
click here to find a list of Valproate Sodium (Depacon) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Valproate Sodium (Depacon) DMF (Drug Master File) is a document detailing the whole manufacturing process of Valproate Sodium (Depacon) active pharmaceutical ingredient (API) in detail. Different forms of Valproate Sodium (Depacon) DMFs exist exist since differing nations have different regulations, such as Valproate Sodium (Depacon) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valproate Sodium (Depacon) DMF submitted to regulatory agencies in the US is known as a USDMF. Valproate Sodium (Depacon) USDMF includes data on Valproate Sodium (Depacon)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valproate Sodium (Depacon) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) Drug Master File in Japan (Valproate Sodium (Depacon) JDMF) empowers Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) JDMF during the approval evaluation for pharmaceutical products. At the time of Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) Drug Master File in Korea (Valproate Sodium (Depacon) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valproate Sodium (Depacon). The MFDS reviews the Valproate Sodium (Depacon) KDMF as part of the drug registration process and uses the information provided in the Valproate Sodium (Depacon) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valproate Sodium (Depacon) suppliers with KDMF on PharmaCompass.
A Valproate Sodium (Depacon) CEP of the European Pharmacopoeia monograph is often referred to as a Valproate Sodium (Depacon) Certificate of Suitability (COS). The purpose of a Valproate Sodium (Depacon) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Valproate Sodium (Depacon) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Valproate Sodium (Depacon) to their clients by showing that a Valproate Sodium (Depacon) CEP has been issued for it. The manufacturer submits a Valproate Sodium (Depacon) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Valproate Sodium (Depacon) CEP holder for the record. Additionally, the data presented in the Valproate Sodium (Depacon) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Valproate Sodium (Depacon) DMF.
A Valproate Sodium (Depacon) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) suppliers with CEP (COS) on PharmaCompass.
A Valproate Sodium (Depacon) written confirmation (Valproate Sodium (Depacon) WC) is an official document issued by a regulatory agency to a Valproate Sodium (Depacon) manufacturer, verifying that the manufacturing facility of a Valproate Sodium (Depacon) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valproate Sodium (Depacon) APIs or Valproate Sodium (Depacon) finished pharmaceutical products to another nation, regulatory agencies frequently require a Valproate Sodium (Depacon) WC (written confirmation) as part of the regulatory process.
click here to find a list of Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valproate Sodium (Depacon) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valproate Sodium (Depacon) suppliers with NDC on PharmaCompass.
Valproate Sodium (Depacon) 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 Valproate Sodium (Depacon) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Valproate Sodium (Depacon) GMP manufacturer or Valproate Sodium (Depacon) GMP API supplier for your needs.
A Valproate Sodium (Depacon) CoA (Certificate of Analysis) is a formal document that attests to Valproate Sodium (Depacon)'s compliance with Valproate Sodium (Depacon) specifications and serves as a tool for batch-level quality control.
Valproate Sodium (Depacon) CoA mostly includes findings from lab analyses of a specific batch. For each Valproate Sodium (Depacon) 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.
Valproate Sodium (Depacon) may be tested according to a variety of international standards, such as European Pharmacopoeia (Valproate Sodium (Depacon) EP), Valproate Sodium (Depacon) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valproate Sodium (Depacon) USP).
