Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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USDMF
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-13
DMF Number : 26316
Submission : 2012-10-09
Status :
Type : II
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Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
About the Company : Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of ...
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API Imports and Exports
Drugs in Development
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DOSAGE - SUSPENSION;ORAL - 40MG/ML
USFDA APPLICATION NUMBER - 201367
DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21911
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 21911
DOSAGE - TABLET;ORAL - 400MG
USFDA APPLICATION NUMBER - 21911
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Pharmacopoeia Ref : NA
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : DC SIM 100 is a directly compressible simethicone powder used for antacid and anti-gas tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Softgels
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
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Fillers, Diluents & Binders
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Granulation
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Topical
Lubricants & Glidants
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Rheology Modifiers
Solubilizers
Co-Processed Excipients
Chewable & Orodispersible Aids
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Digital Content
NEWS #PharmaBuzz
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Rufinamide 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 Rufinamide manufacturer or Rufinamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rufinamide manufacturer or Rufinamide supplier.
PharmaCompass also assists you with knowing the Rufinamide API Price utilized in the formulation of products. Rufinamide API Price is not always fixed or binding as the Rufinamide Price is obtained through a variety of data sources. The Rufinamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Banzel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Banzel, including repackagers and relabelers. The FDA regulates Banzel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Banzel 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 Banzel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Banzel supplier is an individual or a company that provides Banzel active pharmaceutical ingredient (API) or Banzel finished formulations upon request. The Banzel suppliers may include Banzel API manufacturers, exporters, distributors and traders.
click here to find a list of Banzel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Banzel DMF (Drug Master File) is a document detailing the whole manufacturing process of Banzel active pharmaceutical ingredient (API) in detail. Different forms of Banzel DMFs exist exist since differing nations have different regulations, such as Banzel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Banzel DMF submitted to regulatory agencies in the US is known as a USDMF. Banzel USDMF includes data on Banzel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Banzel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Banzel suppliers with USDMF on PharmaCompass.
A Banzel written confirmation (Banzel WC) is an official document issued by a regulatory agency to a Banzel manufacturer, verifying that the manufacturing facility of a Banzel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Banzel APIs or Banzel finished pharmaceutical products to another nation, regulatory agencies frequently require a Banzel WC (written confirmation) as part of the regulatory process.
click here to find a list of Banzel 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 Banzel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Banzel 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 Banzel 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 Banzel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Banzel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Banzel suppliers with NDC on PharmaCompass.
Banzel 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 Banzel 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 Banzel GMP manufacturer or Banzel GMP API supplier for your needs.
A Banzel CoA (Certificate of Analysis) is a formal document that attests to Banzel's compliance with Banzel specifications and serves as a tool for batch-level quality control.
Banzel CoA mostly includes findings from lab analyses of a specific batch. For each Banzel 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.
Banzel may be tested according to a variety of international standards, such as European Pharmacopoeia (Banzel EP), Banzel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Banzel USP).
Comment (6)
