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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 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, COA and API Price 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, COA and API Price 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.
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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).
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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.
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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, API price, 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).
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