Synopsis
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CEP/COS
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JDMF
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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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FDA Orange Book
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Australia
DRUG PRODUCT COMPOSITIONS
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
KDMF 
ASMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
With Virupaksha, you get a quality product with on-time delivery.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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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
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36637
Submission : 2022-01-17
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
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners 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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2018-12-20
DMF Number : 33457
Submission : 2019-02-28
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 : 2019-06-20
Pay. Date : 2019-05-07
DMF Number : 33657
Submission : 2019-05-09
Status :
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reach...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma was established in 1986 and began operating as a fully integrated pharmaceutical company in 1995. The company offers a broad portfolio across multiple therapeutic ca...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
About the Company : Polpharma API, a division of a leading Polish pharmaceutical group, has over 75 years of expertise in process development and cGMP manufacturing. Based at an FDA-approved site in C...
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
About the Company : IOL Chemicals and Pharmaceuticals Limited, with over three decades of experience, is an innovation-driven company specializing in bulk drugs, intermediates, and specialty chemicals...
With Virupaksha, you get a quality product with on-time delivery.
About the Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylaram produce high-qual...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
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API Imports and Exports
Drugs in Development
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Global Sales Information
US Medicaid Prescriptions
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Health Canada Patents
Patent Expiration Date : 2026-11-08
Date Granted : 2013-01-08
SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX
Brand Name : SACUBITRIL-VALSARTAN
Patent Number : 2590511
Filing Date : 2006-11-08
Strength per Unit : 24mg / 26mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2026-11-08
Date Granted : 2013-01-08
Patent Expiration Date : 2028-11-04
Date Granted : 2016-08-09
SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX
Brand Name : SACUBITRIL-VALSARTAN
Patent Number : 2703598
Filing Date : 2008-11-04
Strength per Unit : 24mg / 26mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2028-11-04
Date Granted : 2016-08-09
Patent Expiration Date : 2026-11-08
Date Granted : 2013-01-08
SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX
Brand Name : SACUBITRIL-VALSARTAN
Patent Number : 2590511
Filing Date : 2006-11-08
Strength per Unit : 49mg / 51mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2026-11-08
Date Granted : 2013-01-08
Patent Expiration Date : 2028-11-04
Date Granted : 2016-08-09
SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX
Brand Name : SACUBITRIL-VALSARTAN
Patent Number : 2703598
Filing Date : 2008-11-04
Strength per Unit : 49mg / 51mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2028-11-04
Date Granted : 2016-08-09
Patent Expiration Date : 2026-11-08
Date Granted : 2013-01-08
SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX
Brand Name : SACUBITRIL-VALSARTAN
Patent Number : 2590511
Filing Date : 2006-11-08
Strength per Unit : 97mg / 103mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2026-11-08
Date Granted : 2013-01-08
Patent Expiration Date : 2028-11-04
Date Granted : 2016-08-09
SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX
Brand Name : SACUBITRIL-VALSARTAN
Patent Number : 2703598
Filing Date : 2008-11-04
Strength per Unit : 97mg / 103mg
Dosage Form : TABLET
Human Or VET : Human
Route of Administration : ORAL
Patent Expiration Date : 2028-11-04
Date Granted : 2016-08-09
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Sacubitril-Valsartan 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 Sacubitril-Valsartan manufacturer or Sacubitril-Valsartan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sacubitril-Valsartan manufacturer or Sacubitril-Valsartan supplier.
PharmaCompass also assists you with knowing the Sacubitril-Valsartan API Price utilized in the formulation of products. Sacubitril-Valsartan API Price is not always fixed or binding as the Sacubitril-Valsartan Price is obtained through a variety of data sources. The Sacubitril-Valsartan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A sacubitril valsartan sodium anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sacubitril valsartan sodium anhydrous, including repackagers and relabelers. The FDA regulates sacubitril valsartan sodium anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sacubitril valsartan sodium anhydrous 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 sodium anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A sacubitril valsartan sodium anhydrous supplier is an individual or a company that provides sacubitril valsartan sodium anhydrous active pharmaceutical ingredient (API) or sacubitril valsartan sodium anhydrous finished formulations upon request. The sacubitril valsartan sodium anhydrous suppliers may include sacubitril valsartan sodium anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of sacubitril valsartan sodium anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A sacubitril valsartan sodium anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of sacubitril valsartan sodium anhydrous active pharmaceutical ingredient (API) in detail. Different forms of sacubitril valsartan sodium anhydrous DMFs exist exist since differing nations have different regulations, such as sacubitril valsartan sodium anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sacubitril valsartan sodium anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. sacubitril valsartan sodium anhydrous USDMF includes data on sacubitril valsartan sodium anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sacubitril valsartan sodium anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of sacubitril valsartan sodium anhydrous 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 sodium anhydrous Drug Master File in Korea (sacubitril valsartan sodium anhydrous KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of sacubitril valsartan sodium anhydrous. The MFDS reviews the sacubitril valsartan sodium anhydrous KDMF as part of the drug registration process and uses the information provided in the sacubitril valsartan sodium anhydrous KDMF to evaluate the safety and efficacy of the drug.
After submitting a sacubitril valsartan sodium anhydrous 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 sodium anhydrous API can apply through the Korea Drug Master File (KDMF).
click here to find a list of sacubitril valsartan sodium anhydrous suppliers with KDMF on PharmaCompass.
A sacubitril valsartan sodium anhydrous written confirmation (sacubitril valsartan sodium anhydrous WC) is an official document issued by a regulatory agency to a sacubitril valsartan sodium anhydrous manufacturer, verifying that the manufacturing facility of a sacubitril valsartan sodium anhydrous active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting sacubitril valsartan sodium anhydrous APIs or sacubitril valsartan sodium anhydrous finished pharmaceutical products to another nation, regulatory agencies frequently require a sacubitril valsartan sodium anhydrous WC (written confirmation) as part of the regulatory process.
click here to find a list of sacubitril valsartan sodium anhydrous 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 sodium anhydrous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for sacubitril valsartan sodium anhydrous 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 sodium anhydrous 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 sodium anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a sacubitril valsartan sodium anhydrous NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of sacubitril valsartan sodium anhydrous suppliers with NDC on PharmaCompass.
sacubitril valsartan sodium anhydrous 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 sodium anhydrous 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 sodium anhydrous GMP manufacturer or sacubitril valsartan sodium anhydrous GMP API supplier for your needs.
A sacubitril valsartan sodium anhydrous CoA (Certificate of Analysis) is a formal document that attests to sacubitril valsartan sodium anhydrous's compliance with sacubitril valsartan sodium anhydrous specifications and serves as a tool for batch-level quality control.
sacubitril valsartan sodium anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each sacubitril valsartan sodium anhydrous 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 sodium anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (sacubitril valsartan sodium anhydrous EP), sacubitril valsartan sodium anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (sacubitril valsartan sodium anhydrous USP).
