Synopsis
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JDMF
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KDMF
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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
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
NDC 
ASMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
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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
Lead Product(s) : Amlitelimab,Midazolam,Caffeine,Metoprolol Tartrate,Omeprazole,Warfarin Sodium
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Amlitelimab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Dermatitis, Atopic.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
November 13, 2024
Lead Product(s) : Risankizumab,Midazolam,Caffeine,Warfarin Sodium,Vitamin K1,Omeprazole,Metoprolol Tartrate
Therapeutic Area : Immunology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Risankizumab is a Antibody drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Colitis, Ulcerative.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
February 05, 2020
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 1MG **Federal Register...DOSAGE - TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 2.5MG
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 3MG
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 6MG
USFDA APPLICATION NUMBER - 9218
DOSAGE - TABLET;ORAL - 7.5MG
USFDA APPLICATION NUMBER - 9218
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Direct Compression
Coating Systems & Additives
Granulation
Disintegrants & Superdisintegrants
Chewable & Orodispersible Aids
Controlled & Modified Release
Thickeners and Stabilizers
Taste Masking
Co-Processed Excipients
Parenteral
Lubricants & Glidants
Solubilizers
Rheology Modifiers
Film Formers & Plasticizers
Empty Capsules
Emulsifying Agents
Vegetarian Capsules
API Stability Enhancers
Coloring Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ANALYTICAL
BioAnalytical Methods
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ABOUT THIS PAGE
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PharmaCompass offers a list of Warfarin 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 Warfarin Sodium manufacturer or Warfarin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Warfarin Sodium manufacturer or Warfarin Sodium supplier.
PharmaCompass also assists you with knowing the Warfarin Sodium API Price utilized in the formulation of products. Warfarin Sodium API Price is not always fixed or binding as the Warfarin Sodium Price is obtained through a variety of data sources. The Warfarin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Warfarin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Warfarin Sodium, including repackagers and relabelers. The FDA regulates Warfarin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Warfarin 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 Warfarin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Warfarin Sodium supplier is an individual or a company that provides Warfarin Sodium active pharmaceutical ingredient (API) or Warfarin Sodium finished formulations upon request. The Warfarin Sodium suppliers may include Warfarin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Warfarin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Warfarin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Warfarin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Warfarin Sodium DMFs exist exist since differing nations have different regulations, such as Warfarin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Warfarin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Warfarin Sodium USDMF includes data on Warfarin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Warfarin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Warfarin Sodium suppliers with USDMF on PharmaCompass.
A Warfarin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Warfarin Sodium Certificate of Suitability (COS). The purpose of a Warfarin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Warfarin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Warfarin Sodium to their clients by showing that a Warfarin Sodium CEP has been issued for it. The manufacturer submits a Warfarin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Warfarin Sodium CEP holder for the record. Additionally, the data presented in the Warfarin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Warfarin Sodium DMF.
A Warfarin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Warfarin 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 Warfarin Sodium suppliers with CEP (COS) on PharmaCompass.
A Warfarin Sodium written confirmation (Warfarin Sodium WC) is an official document issued by a regulatory agency to a Warfarin Sodium manufacturer, verifying that the manufacturing facility of a Warfarin Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Warfarin Sodium APIs or Warfarin Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Warfarin Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Warfarin 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 Warfarin Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Warfarin 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 Warfarin 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 Warfarin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Warfarin Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Warfarin Sodium suppliers with NDC on PharmaCompass.
Warfarin 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 Warfarin 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 Warfarin Sodium GMP manufacturer or Warfarin Sodium GMP API supplier for your needs.
A Warfarin Sodium CoA (Certificate of Analysis) is a formal document that attests to Warfarin Sodium's compliance with Warfarin Sodium specifications and serves as a tool for batch-level quality control.
Warfarin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Warfarin 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.
Warfarin Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Warfarin Sodium EP), Warfarin Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Warfarin Sodium USP).
