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CEP/COS
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DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
EU-WC
NDC
CA, BR, ...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
CA, BR, ...
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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
INTERMEDIATE SUPPLIERS
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We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q2 2019
Registration Country : Germany
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DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federa...DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 12.5MG ACID
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 25MG ACID
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 50MG ACID
USFDA APPLICATION NUMBER - 22291
DOSAGE - TABLET;ORAL - EQ 75MG ACID
USFDA APPLICATION NUMBER - 22291
Related Excipient Companies
Rochem International Inc
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Fillers, Diluents & Binders
Controlled & Modified Release
Direct Compression
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Solubilizers
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.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Granulation
Taste Masking
Chewable & Orodispersible Aids
Parenteral
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.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
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 also used as a stabilizer in liquid formulations & as a bulking agent in tablets.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Lubricants & Glidants
Film Formers & Plasticizers
Co-Processed Excipients
Topical
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Cream / Lotion / Ointment, Suspension, Solution, Syrup
Grade : Topical, Oral
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Xantural 11000 is used as a stabilizer and rheology modifier in oral dosage forms such as syrups, suspensions & solutions & in topical formulations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Cream / Lotion / Ointment, Suspension, Solution, Syrup
Grade : Topical, Oral
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Xantural 180 is used as a rheology modifier & stabilizer in oral dosage forms such as solutions, suspensions, and syrups & in topical formulations.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Rheology Modifiers
API Stability Enhancers
Empty Capsules
Coloring Agents
Emulsifying Agents
Vegetarian Capsules
Surfactant & Foaming Agents
Digital Content
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USP
ABOUT THIS PAGE
33
PharmaCompass offers a list of Eltrombopag 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 Eltrombopag manufacturer or Eltrombopag supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eltrombopag manufacturer or Eltrombopag supplier.
PharmaCompass also assists you with knowing the Eltrombopag API Price utilized in the formulation of products. Eltrombopag API Price is not always fixed or binding as the Eltrombopag Price is obtained through a variety of data sources. The Eltrombopag Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eltrombopag manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eltrombopag, including repackagers and relabelers. The FDA regulates Eltrombopag manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eltrombopag 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 Eltrombopag manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eltrombopag supplier is an individual or a company that provides Eltrombopag active pharmaceutical ingredient (API) or Eltrombopag finished formulations upon request. The Eltrombopag suppliers may include Eltrombopag API manufacturers, exporters, distributors and traders.
click here to find a list of Eltrombopag suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eltrombopag DMF (Drug Master File) is a document detailing the whole manufacturing process of Eltrombopag active pharmaceutical ingredient (API) in detail. Different forms of Eltrombopag DMFs exist exist since differing nations have different regulations, such as Eltrombopag USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eltrombopag DMF submitted to regulatory agencies in the US is known as a USDMF. Eltrombopag USDMF includes data on Eltrombopag's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eltrombopag USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eltrombopag 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 Eltrombopag Drug Master File in Japan (Eltrombopag JDMF) empowers Eltrombopag 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 Eltrombopag JDMF during the approval evaluation for pharmaceutical products. At the time of Eltrombopag 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 Eltrombopag 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 Eltrombopag Drug Master File in Korea (Eltrombopag KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eltrombopag. The MFDS reviews the Eltrombopag KDMF as part of the drug registration process and uses the information provided in the Eltrombopag KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eltrombopag 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 Eltrombopag API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eltrombopag suppliers with KDMF on PharmaCompass.
A Eltrombopag written confirmation (Eltrombopag WC) is an official document issued by a regulatory agency to a Eltrombopag manufacturer, verifying that the manufacturing facility of a Eltrombopag active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eltrombopag APIs or Eltrombopag finished pharmaceutical products to another nation, regulatory agencies frequently require a Eltrombopag WC (written confirmation) as part of the regulatory process.
click here to find a list of Eltrombopag 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 Eltrombopag as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eltrombopag 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 Eltrombopag 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 Eltrombopag and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eltrombopag NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eltrombopag suppliers with NDC on PharmaCompass.
Eltrombopag 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 Eltrombopag 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 Eltrombopag GMP manufacturer or Eltrombopag GMP API supplier for your needs.
A Eltrombopag CoA (Certificate of Analysis) is a formal document that attests to Eltrombopag's compliance with Eltrombopag specifications and serves as a tool for batch-level quality control.
Eltrombopag CoA mostly includes findings from lab analyses of a specific batch. For each Eltrombopag 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.
Eltrombopag may be tested according to a variety of international standards, such as European Pharmacopoeia (Eltrombopag EP), Eltrombopag JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eltrombopag USP).
