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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approv...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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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
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
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PharmaCompass offers a list of Eltrombopag API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Eltrombopag Olamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eltrombopag Olamine, including repackagers and relabelers. The FDA regulates Eltrombopag Olamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eltrombopag Olamine 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 Olamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Eltrombopag Olamine supplier is an individual or a company that provides Eltrombopag Olamine active pharmaceutical ingredient (API) or Eltrombopag Olamine finished formulations upon request. The Eltrombopag Olamine suppliers may include Eltrombopag Olamine API manufacturers, exporters, distributors and traders.
click here to find a list of Eltrombopag Olamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Eltrombopag Olamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Eltrombopag Olamine active pharmaceutical ingredient (API) in detail. Different forms of Eltrombopag Olamine DMFs exist exist since differing nations have different regulations, such as Eltrombopag Olamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eltrombopag Olamine DMF submitted to regulatory agencies in the US is known as a USDMF. Eltrombopag Olamine USDMF includes data on Eltrombopag Olamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eltrombopag Olamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eltrombopag Olamine 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 Olamine Drug Master File in Japan (Eltrombopag Olamine JDMF) empowers Eltrombopag Olamine 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 Olamine JDMF during the approval evaluation for pharmaceutical products. At the time of Eltrombopag Olamine 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 Olamine 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 Olamine Drug Master File in Korea (Eltrombopag Olamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eltrombopag Olamine. The MFDS reviews the Eltrombopag Olamine KDMF as part of the drug registration process and uses the information provided in the Eltrombopag Olamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eltrombopag Olamine 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 Olamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eltrombopag Olamine suppliers with KDMF on PharmaCompass.
A Eltrombopag Olamine written confirmation (Eltrombopag Olamine WC) is an official document issued by a regulatory agency to a Eltrombopag Olamine manufacturer, verifying that the manufacturing facility of a Eltrombopag Olamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eltrombopag Olamine APIs or Eltrombopag Olamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Eltrombopag Olamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Eltrombopag Olamine 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 Olamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eltrombopag Olamine 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 Olamine 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 Olamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eltrombopag Olamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eltrombopag Olamine suppliers with NDC on PharmaCompass.
Eltrombopag Olamine 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 Olamine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Eltrombopag Olamine GMP manufacturer or Eltrombopag Olamine GMP API supplier for your needs.
A Eltrombopag Olamine CoA (Certificate of Analysis) is a formal document that attests to Eltrombopag Olamine's compliance with Eltrombopag Olamine specifications and serves as a tool for batch-level quality control.
Eltrombopag Olamine CoA mostly includes findings from lab analyses of a specific batch. For each Eltrombopag Olamine 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 Olamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Eltrombopag Olamine EP), Eltrombopag Olamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eltrombopag Olamine USP).
