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API SUPPLIERS
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-22
Pay. Date : 2017-11-08
DMF Number : 31574
Submission : 2017-08-29
Status :
Type : II
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-04
Pay. Date : 2017-12-20
DMF Number : 32337
Submission : 2017-12-21
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37994
Submission : 2023-03-09
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-12-20
DMF Number : 33457
Submission : 2019-02-28
Status :
Type : II
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ABOUT THIS PAGE
A Entresto manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entresto, including repackagers and relabelers. The FDA regulates Entresto manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entresto 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 Entresto manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entresto supplier is an individual or a company that provides Entresto active pharmaceutical ingredient (API) or Entresto finished formulations upon request. The Entresto suppliers may include Entresto API manufacturers, exporters, distributors and traders.
click here to find a list of Entresto suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Entresto DMF (Drug Master File) is a document detailing the whole manufacturing process of Entresto active pharmaceutical ingredient (API) in detail. Different forms of Entresto DMFs exist exist since differing nations have different regulations, such as Entresto USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Entresto DMF submitted to regulatory agencies in the US is known as a USDMF. Entresto USDMF includes data on Entresto's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Entresto USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Entresto suppliers with USDMF 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 Entresto Drug Master File in Korea (Entresto KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Entresto. The MFDS reviews the Entresto KDMF as part of the drug registration process and uses the information provided in the Entresto KDMF to evaluate the safety and efficacy of the drug.
After submitting a Entresto 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 Entresto API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Entresto suppliers with KDMF on PharmaCompass.
A Entresto written confirmation (Entresto WC) is an official document issued by a regulatory agency to a Entresto manufacturer, verifying that the manufacturing facility of a Entresto active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Entresto APIs or Entresto finished pharmaceutical products to another nation, regulatory agencies frequently require a Entresto WC (written confirmation) as part of the regulatory process.
click here to find a list of Entresto 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 Entresto as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Entresto 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 Entresto 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 Entresto and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Entresto NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Entresto suppliers with NDC on PharmaCompass.
Entresto 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 Entresto 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 Entresto GMP manufacturer or Entresto GMP API supplier for your needs.
A Entresto CoA (Certificate of Analysis) is a formal document that attests to Entresto's compliance with Entresto specifications and serves as a tool for batch-level quality control.
Entresto CoA mostly includes findings from lab analyses of a specific batch. For each Entresto 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.
Entresto may be tested according to a variety of international standards, such as European Pharmacopoeia (Entresto EP), Entresto JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Entresto USP).
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