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DRUG PRODUCT COMPOSITIONS0
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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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14646
Submission : 1999-12-27
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5678
Submission : 1985-01-18
Status :
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-16
Pay. Date : 2014-11-26
DMF Number : 18285
Submission : 2005-04-08
Status :
Type : II
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-13
Pay. Date : 2015-09-08
DMF Number : 16558
Submission : 2003-04-28
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : CEP 2004-226 - Rev 05
Status : Valid
Issue Date : 2024-02-02
Type : Chemical
Substance Number : 1378
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Certificate Number : CEP 2003-108 - Rev 06
Status : Valid
Issue Date : 2025-04-16
Type : Chemical
Substance Number : 1378
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-870
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Chem Pole 64, Avenue Du Lac, Mourenx, 64150, France
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registrant Name : Base Farm Co., Ltd.
Registration Date : 2022-05-17
Registration Number : 20201125-209-J-769(2)
Manufacturer Name : SCI Pharmtech, Inc
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist. Taoyuan City 33856, Taiwan
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-11-25
Registration Number : 20201125-209-J-769
Manufacturer Name : SCI Pharmtech, Inc
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist. Taoyuan City 33856, Taiwan
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2021-08-11
Registration Number : 20201125-209-J-769(1)
Manufacturer Name : SCI Pharmtech, Inc
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist. Taoyuan City 33856, Taiwan
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-05-18
Registration Number : 20210518-211-J-666
Manufacturer Name : SCI Pharmtech, Inc
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist. Taoyuan City 33856, Taiwan
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
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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
Related Excipient Companies
Evonik
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Powder
Grade : Oral
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule
Grade : Oral
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule
Grade : Oral
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule
Grade : Oral
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Tablet
Grade : Oral
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule
Grade : Oral
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Capsule
Grade : Oral
Brand Name : EUDRAGIT® L 100-55
Application : Controlled & Modified Release
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Tablet
Grade : Oral
Application : Solubilizers
Excipient Details : EUDRAGIT® L 12,5 (organic solution), a delayed release polymer is used to increase solubility of poorly soluble products such as tablets and capsules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid Methyl Methacrylate Copolymer
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Tablet
Grade : Oral
Brand Name : EUDRAGIT® L 30 D-55
Application : Film Formers & Plasticizers
Excipient Details : EUDRAGIT® L 30 D-55 (aqueous dispersion) is a delayed release polymer used as coating and film former in tablets, capsules, granules etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
Dosage Form : Tablet
Grade : Oral
Brand Name : EUDRAGIT® RS 12,5
Application : Controlled & Modified Release
Excipient Details : EUDRAGIT® RS 12,5 (Organic solution) is a sustained release polymer for customized release profiles used in combination with EUDRAGIT® RL.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Ethyl Acrylate Methyl Methacrylate Copolymer
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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 Divalproex Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Divalproex Sodium, including repackagers and relabelers. The FDA regulates Divalproex Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Divalproex Sodium 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 Divalproex Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Divalproex Sodium supplier is an individual or a company that provides Divalproex Sodium active pharmaceutical ingredient (API) or Divalproex Sodium finished formulations upon request. The Divalproex Sodium suppliers may include Divalproex Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Divalproex Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Divalproex Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Divalproex Sodium active pharmaceutical ingredient (API) in detail. Different forms of Divalproex Sodium DMFs exist exist since differing nations have different regulations, such as Divalproex Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Divalproex Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Divalproex Sodium USDMF includes data on Divalproex Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Divalproex Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Divalproex Sodium 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 Divalproex Sodium Drug Master File in Japan (Divalproex Sodium JDMF) empowers Divalproex Sodium 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 Divalproex Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Divalproex Sodium 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 Divalproex Sodium 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 Divalproex Sodium Drug Master File in Korea (Divalproex Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Divalproex Sodium. The MFDS reviews the Divalproex Sodium KDMF as part of the drug registration process and uses the information provided in the Divalproex Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Divalproex Sodium 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 Divalproex Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Divalproex Sodium suppliers with KDMF on PharmaCompass.
A Divalproex Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Divalproex Sodium Certificate of Suitability (COS). The purpose of a Divalproex Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Divalproex Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Divalproex Sodium to their clients by showing that a Divalproex Sodium CEP has been issued for it. The manufacturer submits a Divalproex Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Divalproex Sodium CEP holder for the record. Additionally, the data presented in the Divalproex Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Divalproex Sodium DMF.
A Divalproex Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Divalproex Sodium 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 Divalproex Sodium suppliers with CEP (COS) on PharmaCompass.
A Divalproex Sodium written confirmation (Divalproex Sodium WC) is an official document issued by a regulatory agency to a Divalproex Sodium manufacturer, verifying that the manufacturing facility of a Divalproex Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Divalproex Sodium APIs or Divalproex Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Divalproex Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Divalproex Sodium 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 Divalproex Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Divalproex Sodium 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 Divalproex Sodium 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 Divalproex Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Divalproex Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Divalproex Sodium suppliers with NDC on PharmaCompass.
Divalproex Sodium 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 Divalproex Sodium 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 Divalproex Sodium GMP manufacturer or Divalproex Sodium GMP API supplier for your needs.
A Divalproex Sodium CoA (Certificate of Analysis) is a formal document that attests to Divalproex Sodium's compliance with Divalproex Sodium specifications and serves as a tool for batch-level quality control.
Divalproex Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Divalproex Sodium 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.
Divalproex Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Divalproex Sodium EP), Divalproex Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Divalproex Sodium USP).
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