Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
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
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.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
Jai Radhe Sales is your partner for all your sourcing needs.
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
CA, CN
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USDMF
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
About the Company : We’re a company that takes on the toughest health challenges. But we do more than treat diseases—we aim to make a remarkable impact on people’s lives. We are AbbVie, a highly...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...
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, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
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, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
Venkar Chemicals – WHO-GMP & ISO Certified API Experts Delivering Global Standards.
About the Company : Venkar Chemicals Pvt. Ltd. is a WHO-GMP, ISO 9001:2008, and ISO 14000:2004 certified company and a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediate...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals...
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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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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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NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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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 Delepsine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Delepsine, including repackagers and relabelers. The FDA regulates Delepsine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Delepsine 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 Delepsine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Delepsine supplier is an individual or a company that provides Delepsine active pharmaceutical ingredient (API) or Delepsine finished formulations upon request. The Delepsine suppliers may include Delepsine API manufacturers, exporters, distributors and traders.
click here to find a list of Delepsine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Delepsine DMF (Drug Master File) is a document detailing the whole manufacturing process of Delepsine active pharmaceutical ingredient (API) in detail. Different forms of Delepsine DMFs exist exist since differing nations have different regulations, such as Delepsine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Delepsine DMF submitted to regulatory agencies in the US is known as a USDMF. Delepsine USDMF includes data on Delepsine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Delepsine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Delepsine 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 Delepsine Drug Master File in Japan (Delepsine JDMF) empowers Delepsine 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 Delepsine JDMF during the approval evaluation for pharmaceutical products. At the time of Delepsine 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 Delepsine 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 Delepsine Drug Master File in Korea (Delepsine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Delepsine. The MFDS reviews the Delepsine KDMF as part of the drug registration process and uses the information provided in the Delepsine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Delepsine 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 Delepsine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Delepsine suppliers with KDMF on PharmaCompass.
A Delepsine CEP of the European Pharmacopoeia monograph is often referred to as a Delepsine Certificate of Suitability (COS). The purpose of a Delepsine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Delepsine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Delepsine to their clients by showing that a Delepsine CEP has been issued for it. The manufacturer submits a Delepsine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Delepsine CEP holder for the record. Additionally, the data presented in the Delepsine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Delepsine DMF.
A Delepsine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Delepsine 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 Delepsine suppliers with CEP (COS) on PharmaCompass.
A Delepsine written confirmation (Delepsine WC) is an official document issued by a regulatory agency to a Delepsine manufacturer, verifying that the manufacturing facility of a Delepsine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Delepsine APIs or Delepsine finished pharmaceutical products to another nation, regulatory agencies frequently require a Delepsine WC (written confirmation) as part of the regulatory process.
click here to find a list of Delepsine 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 Delepsine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Delepsine 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 Delepsine 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 Delepsine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Delepsine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Delepsine suppliers with NDC on PharmaCompass.
Delepsine 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 Delepsine 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 Delepsine GMP manufacturer or Delepsine GMP API supplier for your needs.
A Delepsine CoA (Certificate of Analysis) is a formal document that attests to Delepsine's compliance with Delepsine specifications and serves as a tool for batch-level quality control.
Delepsine CoA mostly includes findings from lab analyses of a specific batch. For each Delepsine 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.
Delepsine may be tested according to a variety of international standards, such as European Pharmacopoeia (Delepsine EP), Delepsine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Delepsine USP).
