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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 Sacubitril-Valsartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacubitril-Valsartan, including repackagers and relabelers. The FDA regulates Sacubitril-Valsartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacubitril-Valsartan 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 Sacubitril-Valsartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sacubitril-Valsartan supplier is an individual or a company that provides Sacubitril-Valsartan active pharmaceutical ingredient (API) or Sacubitril-Valsartan finished formulations upon request. The Sacubitril-Valsartan suppliers may include Sacubitril-Valsartan API manufacturers, exporters, distributors and traders.
click here to find a list of Sacubitril-Valsartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sacubitril-Valsartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Sacubitril-Valsartan active pharmaceutical ingredient (API) in detail. Different forms of Sacubitril-Valsartan DMFs exist exist since differing nations have different regulations, such as Sacubitril-Valsartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sacubitril-Valsartan DMF submitted to regulatory agencies in the US is known as a USDMF. Sacubitril-Valsartan USDMF includes data on Sacubitril-Valsartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sacubitril-Valsartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sacubitril-Valsartan 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 Sacubitril-Valsartan Drug Master File in Korea (Sacubitril-Valsartan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sacubitril-Valsartan. The MFDS reviews the Sacubitril-Valsartan KDMF as part of the drug registration process and uses the information provided in the Sacubitril-Valsartan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sacubitril-Valsartan 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 Sacubitril-Valsartan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sacubitril-Valsartan suppliers with KDMF on PharmaCompass.
A Sacubitril-Valsartan written confirmation (Sacubitril-Valsartan WC) is an official document issued by a regulatory agency to a Sacubitril-Valsartan manufacturer, verifying that the manufacturing facility of a Sacubitril-Valsartan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sacubitril-Valsartan APIs or Sacubitril-Valsartan finished pharmaceutical products to another nation, regulatory agencies frequently require a Sacubitril-Valsartan WC (written confirmation) as part of the regulatory process.
click here to find a list of Sacubitril-Valsartan 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 Sacubitril-Valsartan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sacubitril-Valsartan 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 Sacubitril-Valsartan 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 Sacubitril-Valsartan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sacubitril-Valsartan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sacubitril-Valsartan suppliers with NDC on PharmaCompass.
Sacubitril-Valsartan 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 Sacubitril-Valsartan 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 Sacubitril-Valsartan GMP manufacturer or Sacubitril-Valsartan GMP API supplier for your needs.
A Sacubitril-Valsartan CoA (Certificate of Analysis) is a formal document that attests to Sacubitril-Valsartan's compliance with Sacubitril-Valsartan specifications and serves as a tool for batch-level quality control.
Sacubitril-Valsartan CoA mostly includes findings from lab analyses of a specific batch. For each Sacubitril-Valsartan 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.
Sacubitril-Valsartan may be tested according to a variety of international standards, such as European Pharmacopoeia (Sacubitril-Valsartan EP), Sacubitril-Valsartan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sacubitril-Valsartan USP).
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