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API SUPPLIERS
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USDMF
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
AMI Lifesciences is Driven by Chemistry. Powered by People.
Sacubitril Valsartan Trisodium Salt Hemipentahydrate IH
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post Karakhadi, Tal - Padra, Dist. Baroda, Gujara...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Sacubutril Valsartan Sodium on Colloidal SiliconDioxide IH
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Sacubitril Valsartan Sodium Hydrate IH
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm : Plot No:4, Hetero Infrastructure SEZ Ltd.,Narasapuram, Visakhapatnam-531081, And...
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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 And Valsartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacubitril And Valsartan, including repackagers and relabelers. The FDA regulates Sacubitril And Valsartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacubitril And 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 And Valsartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sacubitril And Valsartan supplier is an individual or a company that provides Sacubitril And Valsartan active pharmaceutical ingredient (API) or Sacubitril And Valsartan finished formulations upon request. The Sacubitril And Valsartan suppliers may include Sacubitril And Valsartan API manufacturers, exporters, distributors and traders.
click here to find a list of Sacubitril And Valsartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sacubitril And Valsartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Sacubitril And Valsartan active pharmaceutical ingredient (API) in detail. Different forms of Sacubitril And Valsartan DMFs exist exist since differing nations have different regulations, such as Sacubitril And Valsartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sacubitril And Valsartan DMF submitted to regulatory agencies in the US is known as a USDMF. Sacubitril And Valsartan USDMF includes data on Sacubitril And Valsartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sacubitril And Valsartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sacubitril And 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 And Valsartan Drug Master File in Korea (Sacubitril And Valsartan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sacubitril And Valsartan. The MFDS reviews the Sacubitril And Valsartan KDMF as part of the drug registration process and uses the information provided in the Sacubitril And Valsartan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sacubitril And 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 And Valsartan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sacubitril And Valsartan suppliers with KDMF on PharmaCompass.
A Sacubitril And Valsartan written confirmation (Sacubitril And Valsartan WC) is an official document issued by a regulatory agency to a Sacubitril And Valsartan manufacturer, verifying that the manufacturing facility of a Sacubitril And Valsartan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sacubitril And Valsartan APIs or Sacubitril And Valsartan finished pharmaceutical products to another nation, regulatory agencies frequently require a Sacubitril And Valsartan WC (written confirmation) as part of the regulatory process.
click here to find a list of Sacubitril And 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 And Valsartan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sacubitril And 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 And 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 And Valsartan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sacubitril And Valsartan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sacubitril And Valsartan suppliers with NDC on PharmaCompass.
Sacubitril And 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 And Valsartan 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 And Valsartan GMP manufacturer or Sacubitril And Valsartan GMP API supplier for your needs.
A Sacubitril And Valsartan CoA (Certificate of Analysis) is a formal document that attests to Sacubitril And Valsartan's compliance with Sacubitril And Valsartan specifications and serves as a tool for batch-level quality control.
Sacubitril And Valsartan CoA mostly includes findings from lab analyses of a specific batch. For each Sacubitril And 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 And Valsartan may be tested according to a variety of international standards, such as European Pharmacopoeia (Sacubitril And Valsartan EP), Sacubitril And Valsartan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sacubitril And Valsartan USP).
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