Synopsis
0
CEP/COS
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
API SUPPLIERS
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USDMF
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40357
Submission : 2024-11-25
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-13
Pay. Date : 2024-01-08
DMF Number : 39129
Submission : 2023-12-31
Status :
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-25
Pay. Date : 2022-09-28
DMF Number : 37269
Submission : 2022-08-29
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-08
Pay. Date : 2023-09-28
DMF Number : 38008
Submission : 2023-03-31
Status :
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40868
Submission : 2024-11-28
Status :
Type : II
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag Olamine
Dosage Form : Pre Filled Oral Suspen...
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag Olamine
Dosage Form : Pre Filled Oral Suspen...
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag Olamine
Dosage Form : Immediate Release Tabl...
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag Olamine
Dosage Form : Immediate Release Tabl...
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag Olamine
Dosage Form : Immediate Release Tabl...
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag Olamine
Dosage Form : Immediate Release Tabl...
Dosage Strength : 75MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag
Dosage Form : Oral
Dosage Strength : 12.5 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag
Dosage Form : Oral
Dosage Strength : 25 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag
Dosage Form : Oral
Dosage Strength : 50 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Eltrombopag
Dosage Form : Oral
Dosage Strength : 75 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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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
USP
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 Promacta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Promacta, including repackagers and relabelers. The FDA regulates Promacta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Promacta 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 Promacta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Promacta supplier is an individual or a company that provides Promacta active pharmaceutical ingredient (API) or Promacta finished formulations upon request. The Promacta suppliers may include Promacta API manufacturers, exporters, distributors and traders.
click here to find a list of Promacta suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Promacta DMF (Drug Master File) is a document detailing the whole manufacturing process of Promacta active pharmaceutical ingredient (API) in detail. Different forms of Promacta DMFs exist exist since differing nations have different regulations, such as Promacta USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Promacta DMF submitted to regulatory agencies in the US is known as a USDMF. Promacta USDMF includes data on Promacta's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Promacta USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Promacta 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 Promacta Drug Master File in Japan (Promacta JDMF) empowers Promacta 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 Promacta JDMF during the approval evaluation for pharmaceutical products. At the time of Promacta 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 Promacta 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 Promacta Drug Master File in Korea (Promacta KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Promacta. The MFDS reviews the Promacta KDMF as part of the drug registration process and uses the information provided in the Promacta KDMF to evaluate the safety and efficacy of the drug.
After submitting a Promacta 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 Promacta API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Promacta suppliers with KDMF on PharmaCompass.
A Promacta written confirmation (Promacta WC) is an official document issued by a regulatory agency to a Promacta manufacturer, verifying that the manufacturing facility of a Promacta active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Promacta APIs or Promacta finished pharmaceutical products to another nation, regulatory agencies frequently require a Promacta WC (written confirmation) as part of the regulatory process.
click here to find a list of Promacta 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 Promacta as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Promacta 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 Promacta 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 Promacta and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Promacta NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Promacta suppliers with NDC on PharmaCompass.
Promacta 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 Promacta GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Promacta GMP manufacturer or Promacta GMP API supplier for your needs.
A Promacta CoA (Certificate of Analysis) is a formal document that attests to Promacta's compliance with Promacta specifications and serves as a tool for batch-level quality control.
Promacta CoA mostly includes findings from lab analyses of a specific batch. For each Promacta 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.
Promacta may be tested according to a variety of international standards, such as European Pharmacopoeia (Promacta EP), Promacta JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Promacta USP).
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