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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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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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
AMI Lifesciences is Driven by Chemistry. Powered by People.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
NDC 
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
EU-WC
NDC
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
With Virupaksha, you get a quality product with on-time delivery.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37511
Submission : 2022-10-03
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38786
Submission : 2023-12-28
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-07
Pay. Date : 2023-09-22
DMF Number : 36085
Submission : 2021-07-05
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-28
Pay. Date : 2023-06-27
DMF Number : 36933
Submission : 2022-03-31
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-11-29
DMF Number : 38785
Submission : 2023-09-30
Status :
Type : II
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 36635-61-7
End Use API : Bempedoic Acid
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Ethyl-2,2-dimethyl-7-bromoheptanoate
CAS Number : 123469-92-1
End Use API : Bempedoic Acid
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 180MG
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 : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 120MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 240MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 180MG; 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Bempedoic acid
Dosage Form : Film-Coated Tablet
Dosage Strength : 180MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
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ABOUT THIS PAGE
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PharmaCompass offers a list of Bempedoic Acid 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 Bempedoic Acid manufacturer or Bempedoic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bempedoic Acid manufacturer or Bempedoic Acid supplier.
PharmaCompass also assists you with knowing the Bempedoic Acid API Price utilized in the formulation of products. Bempedoic Acid API Price is not always fixed or binding as the Bempedoic Acid Price is obtained through a variety of data sources. The Bempedoic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bempedoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bempedoic Acid, including repackagers and relabelers. The FDA regulates Bempedoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bempedoic Acid 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 Bempedoic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bempedoic Acid supplier is an individual or a company that provides Bempedoic Acid active pharmaceutical ingredient (API) or Bempedoic Acid finished formulations upon request. The Bempedoic Acid suppliers may include Bempedoic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Bempedoic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bempedoic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Bempedoic Acid active pharmaceutical ingredient (API) in detail. Different forms of Bempedoic Acid DMFs exist exist since differing nations have different regulations, such as Bempedoic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bempedoic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Bempedoic Acid USDMF includes data on Bempedoic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bempedoic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bempedoic Acid suppliers with USDMF on PharmaCompass.
A Bempedoic Acid written confirmation (Bempedoic Acid WC) is an official document issued by a regulatory agency to a Bempedoic Acid manufacturer, verifying that the manufacturing facility of a Bempedoic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bempedoic Acid APIs or Bempedoic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Bempedoic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Bempedoic Acid 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 Bempedoic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bempedoic Acid 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 Bempedoic Acid 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 Bempedoic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bempedoic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bempedoic Acid suppliers with NDC on PharmaCompass.
Bempedoic Acid 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 Bempedoic Acid 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 Bempedoic Acid GMP manufacturer or Bempedoic Acid GMP API supplier for your needs.
A Bempedoic Acid CoA (Certificate of Analysis) is a formal document that attests to Bempedoic Acid's compliance with Bempedoic Acid specifications and serves as a tool for batch-level quality control.
Bempedoic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Bempedoic Acid 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.
Bempedoic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Bempedoic Acid EP), Bempedoic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bempedoic Acid USP).
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