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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
EU-WC
NDC
Suanfarma, at the Core of a Better Life.
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.
NDC
With Virupaksha, you get a quality product with on-time delivery.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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USDMF
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
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
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No. 34B, 40B & 60B, J.N Pharma City, Thanam (V), Parawada (M), Ana...
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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 ...
Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of less than 20 years, the...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI offers customized CDMO Solutions for API development and manufacturing services.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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Drugs in Development
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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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