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
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
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 : 2025-11-14
Pay. Date : 2025-09-15
DMF Number : 42543
Submission : 2025-09-29
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...
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...
Since 1980, Octavius Pharma has been empowering lives by delivering trusted healthcare solutions, including DC granules, APIs, and FDFs
About the Company : Octavius Pharma is a global leader in Directly Compressible (DC) Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our port...
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...
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
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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, 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.
A sacubitril valsartan sodium hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sacubitril valsartan sodium hydrate, including repackagers and relabelers. The FDA regulates sacubitril valsartan sodium hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sacubitril valsartan sodium hydrate 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 hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A sacubitril valsartan sodium hydrate supplier is an individual or a company that provides sacubitril valsartan sodium hydrate active pharmaceutical ingredient (API) or sacubitril valsartan sodium hydrate finished formulations upon request. The sacubitril valsartan sodium hydrate suppliers may include sacubitril valsartan sodium hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of sacubitril valsartan sodium hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A sacubitril valsartan sodium hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of sacubitril valsartan sodium hydrate active pharmaceutical ingredient (API) in detail. Different forms of sacubitril valsartan sodium hydrate DMFs exist exist since differing nations have different regulations, such as sacubitril valsartan sodium hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sacubitril valsartan sodium hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. sacubitril valsartan sodium hydrate USDMF includes data on sacubitril valsartan sodium hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sacubitril valsartan sodium hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of sacubitril valsartan sodium hydrate 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 hydrate Drug Master File in Korea (sacubitril valsartan sodium hydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of sacubitril valsartan sodium hydrate. The MFDS reviews the sacubitril valsartan sodium hydrate KDMF as part of the drug registration process and uses the information provided in the sacubitril valsartan sodium hydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a sacubitril valsartan sodium hydrate 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 hydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of sacubitril valsartan sodium hydrate suppliers with KDMF on PharmaCompass.
A sacubitril valsartan sodium hydrate written confirmation (sacubitril valsartan sodium hydrate WC) is an official document issued by a regulatory agency to a sacubitril valsartan sodium hydrate manufacturer, verifying that the manufacturing facility of a sacubitril valsartan sodium hydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting sacubitril valsartan sodium hydrate APIs or sacubitril valsartan sodium hydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a sacubitril valsartan sodium hydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of sacubitril valsartan sodium hydrate 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 hydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for sacubitril valsartan sodium hydrate 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 hydrate 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 hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a sacubitril valsartan sodium hydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of sacubitril valsartan sodium hydrate suppliers with NDC on PharmaCompass.
sacubitril valsartan sodium hydrate 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 hydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right sacubitril valsartan sodium hydrate GMP manufacturer or sacubitril valsartan sodium hydrate GMP API supplier for your needs.
A sacubitril valsartan sodium hydrate CoA (Certificate of Analysis) is a formal document that attests to sacubitril valsartan sodium hydrate's compliance with sacubitril valsartan sodium hydrate specifications and serves as a tool for batch-level quality control.
sacubitril valsartan sodium hydrate CoA mostly includes findings from lab analyses of a specific batch. For each sacubitril valsartan sodium hydrate 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 hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (sacubitril valsartan sodium hydrate EP), sacubitril valsartan sodium hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (sacubitril valsartan sodium hydrate USP).
