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Canada
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
Details : Sacubitril is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 05, 2024
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Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Valsartan Disodium; Sacubitril Sodium
Brand Name : Sacubitril/Valsartan Pensa
Dosage Form : Film Coated Tablet
Dosage Strength : 49MG;51MG
Packaging :
Approval Date : 12-12-2025
Application Number : 90866
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Valsartan Disodium; Sacubitril Sodium
Brand Name : Sacubitril/Valsartan Pensa
Dosage Form : Film Coated Tablet
Dosage Strength : 24MG;26MG
Packaging :
Approval Date : 11-12-2025
Application Number : 90865
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Valsartan Disodium; Sacubitril Sodium
Brand Name : Sacubitril/Valsartan Pensa
Dosage Form : Film Coated Tablet
Dosage Strength : 97MG;103MG
Packaging :
Approval Date : 12-12-2025
Application Number : 90867
Regulatory Info : Authorized
Registration Country : Spain
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Granulation
Film Formers & Plasticizers
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Emulsifying Agents
Empty Capsules
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07 Jun 2022
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16 Mar 2021
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
48
PharmaCompass offers a list of Sacubitril Sodium 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 Sodium manufacturer or Sacubitril Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sacubitril Sodium manufacturer or Sacubitril Sodium supplier.
A Sacubitril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacubitril, including repackagers and relabelers. The FDA regulates Sacubitril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacubitril 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sacubitril supplier is an individual or a company that provides Sacubitril active pharmaceutical ingredient (API) or Sacubitril finished formulations upon request. The Sacubitril suppliers may include Sacubitril API manufacturers, exporters, distributors and traders.
click here to find a list of Sacubitril suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sacubitril DMF (Drug Master File) is a document detailing the whole manufacturing process of Sacubitril active pharmaceutical ingredient (API) in detail. Different forms of Sacubitril DMFs exist exist since differing nations have different regulations, such as Sacubitril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sacubitril DMF submitted to regulatory agencies in the US is known as a USDMF. Sacubitril USDMF includes data on Sacubitril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sacubitril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sacubitril suppliers with USDMF on PharmaCompass.
A Sacubitril written confirmation (Sacubitril WC) is an official document issued by a regulatory agency to a Sacubitril manufacturer, verifying that the manufacturing facility of a Sacubitril active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sacubitril APIs or Sacubitril finished pharmaceutical products to another nation, regulatory agencies frequently require a Sacubitril WC (written confirmation) as part of the regulatory process.
click here to find a list of Sacubitril 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sacubitril 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 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 are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sacubitril NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sacubitril suppliers with NDC on PharmaCompass.
Sacubitril 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 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 GMP manufacturer or Sacubitril GMP API supplier for your needs.
A Sacubitril CoA (Certificate of Analysis) is a formal document that attests to Sacubitril's compliance with Sacubitril specifications and serves as a tool for batch-level quality control.
Sacubitril CoA mostly includes findings from lab analyses of a specific batch. For each Sacubitril 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Sacubitril EP), Sacubitril JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sacubitril USP).
Comment (6)
