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1. Sacubitril Sodium
2. 149690-05-1
3. Ahu-377 Sodium
4. Sacubitril (sodium)
5. Mop72gep8z
6. Sodium;4-[[(2s,4r)-5-ethoxy-4-methyl-5-oxo-1-(4-phenylphenyl)pentan-2-yl]amino]-4-oxobutanoate
7. Unii-mop72gep8z
8. Sacubitril Sodium Salt
9. Sacubitril Sodium [mi]
10. Schembl21239956
11. Dtxsid90164362
12. Hy-15407b
13. (1,1'-biphenyl)-4-pentanoic Acid, Gamma-((3-carboxy-1-oxopropyl)amino)-alpha-methyl-, 4-ethyl Ester, Sodium Salt (1:1), (alphar,gammas)-
14. Cs-0079358
15. A937423
16. Q27284149
17. (1,1'-biphenyl)-4-pentanoic Acid, .gamma.-((3-carboxy-1-oxopropyl)amino)-.alpha.-methyl-, 4-ethyl Ester, Sodium Salt (1:1), (.alpha.r,.gamma.s)-
18. Sodium 4-(((2s,4r)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoate
Molecular Weight | 433.5 g/mol |
---|---|
Molecular Formula | C24H28NNaO5 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 12 |
Exact Mass | 433.18651728 g/mol |
Monoisotopic Mass | 433.18651728 g/mol |
Topological Polar Surface Area | 95.5 Ų |
Heavy Atom Count | 31 |
Formal Charge | 0 |
Complexity | 556 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40307
Submission : 2024-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38140
Submission : 2023-03-17
Status : Active
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 : 36204
Submission : 2021-10-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-24
Pay. Date : 2019-02-08
DMF Number : 33426
Submission : 2019-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33345
Submission : 2018-12-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33232
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-06
Pay. Date : 2018-10-26
DMF Number : 33251
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33495
Submission : 2019-02-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31271
Submission : 2016-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-28
Pay. Date : 2019-01-28
DMF Number : 33476
Submission : 2018-12-31
Status : Active
Type : II
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm : Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakh...
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm : Sy. No.455/A, 455/AA, 455/E & 455/EE Chandampet Village Shankarampet Mandal Meda...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6260
Start Marketing Date : 2016-05-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65727-079
Start Marketing Date : 2019-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69766-057
Start Marketing Date : 2018-10-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 72023-0012
Start Marketing Date : 2024-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
About the Company : Amara Labs Pvt Ltd is a WHO-GMP certified manufacturing company wholly owned by a team of technocrats with working experience of more than 20 years in Multi-Nationals Companies lik...
About the Company : Aurore Life Sciences is a pure-play API manufacturer with a diverse portfolio of capabilities in delivering efficiencies to generic players globally. Founded in 2017 by a team with...
About the Company : Bulat Pharmaceutical is a fast growing pharmaceutical company, founded in the year 2017, Bulat Pharmaceutical is engaged in the manufacturing and sales of high quality APIs and Int...
About the Company : Harman Finochem Limited is a leading India-based Pharmaceutical Company which specializes in the manufacture and export of more than 45 Active Pharmaceutical Ingredients (APls) of ...
About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...
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Details:
Entresto-Generic (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 24, 2025
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Receives U.S. FDA Approval for Sacubitril and Valsartan Tablets
Details : Entresto-Generic (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure.
Product Name : Entresto-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 24, 2025
Details:
OnArni (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: OnArni
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 15, 2024
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
USV Introduces OnArni, FDC of Sacubitril, Valsartan, For HF Management
Details : OnArni (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.
Product Name : OnArni
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 15, 2024
Details:
Enresto-Generic (sacubitril and valsartan) is an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 07, 2024
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Lifesciences gets USFDA nod to market chronic heart failure treatment drug
Details : Enresto-Generic (sacubitril and valsartan) is an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.
Product Name : Entresto-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 07, 2024
Details:
Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Otsuka Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 02, 2024
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Gains Approval for Entresto for Pediatric Chronic Heart Failure
Details : Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.
Product Name : Entresto
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 02, 2024
Details:
A eneric formulation of sacubitril and valsartan, an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 29, 2024
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets
Details : A eneric formulation of sacubitril and valsartan, an oral neprilysin inhibitor, is approved for the treatment of additional indication of adults chronic heart failure.
Product Name : Entresto-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 29, 2024
Details:
Sacubright (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Sacubright
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 10, 2024
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Exemed Receives CDSCO Nod For Study of Sacubitril Plus Valsartan Sustained-Release Tablet
Details : Sacubright (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.
Product Name : Sacubright
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 10, 2024
Details:
Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Otsuka Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 26, 2024
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Gets Japan Approval for Entresto Granular Tablets for Pediatric Heart Failure Use
Details : Entresto (sacubitril and valsartan) is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of additional indication of pediatric chronic heart failure.
Product Name : Entresto
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 26, 2024
Details:
Sacubitril and valsartan is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 09, 2024
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biocon Unit Gets USFDA Nod For Generic Drug
Details : Sacubitril and valsartan is an oral angiotensin receptor neprilysin inhibitor, which is approved for the treatment of chronic heart failure in 2 years and older patients.
Product Name : Entresto-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 09, 2024
Details:
Entresto contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. It inhibits neprilysin via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 receptor via valsartan in pediatric heart failure.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Entresto
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Otsuka Pharmaceutical
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2023
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Otsuka Pharmaceutical
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Entresto Receives Positive CHMP Opinion for Pediatric Heart Failure
Details : Entresto contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. It inhibits neprilysin via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 receptor via valsartan in pedia...
Product Name : Entresto
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 31, 2023
Details:
Sacubitril and Valsartan drug inhibits neprilysin and blocks angiotensin II type-I receptor, increasing the levels of peptides degraded by neprilysin. It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure.
Lead Product(s): Sacubitril Sodium,Valsartan
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Valentas
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 18, 2023
Lead Product(s) : Sacubitril Sodium,Valsartan
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Launches Sacubitril and Valsartan Combination Drug for Heart Failure Patients
Details : Sacubitril and Valsartan drug inhibits neprilysin and blocks angiotensin II type-I receptor, increasing the levels of peptides degraded by neprilysin. It is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure.
Product Name : Valentas
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 18, 2023
Regulatory Info :
Registration Country : Spain
Brand Name : 56 Neparvis 97/103Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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Regulatory Info :
Registration Country : Spain
Brand Name : 56 Entresto 97/103Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
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Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : 28 Entresto 24/26Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : 28 Neparvis 24/26Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
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Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : 56 Entresto 49/51Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : 56 Neparvis 49/51Mg Film-Coated Tablets
Dosage Form : Film Coated Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Vymada 50 mg
Dosage Form : TAB
Dosage Strength : 24mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Vymada 100 mg
Dosage Form : TAB
Dosage Strength : 49mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Vymada 200 mg
Dosage Form : TAB
Dosage Strength : 97mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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32
PharmaCompass offers a list of Sacubitril Sodium 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 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.
PharmaCompass also assists you with knowing the Sacubitril Sodium API Price utilized in the formulation of products. Sacubitril Sodium API Price is not always fixed or binding as the Sacubitril Sodium Price is obtained through a variety of data sources. The Sacubitril Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sacubitril Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sacubitril Sodium, including repackagers and relabelers. The FDA regulates Sacubitril Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sacubitril Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sacubitril Sodium supplier is an individual or a company that provides Sacubitril Sodium active pharmaceutical ingredient (API) or Sacubitril Sodium finished formulations upon request. The Sacubitril Sodium suppliers may include Sacubitril Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Sacubitril Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sacubitril Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Sacubitril Sodium active pharmaceutical ingredient (API) in detail. Different forms of Sacubitril Sodium DMFs exist exist since differing nations have different regulations, such as Sacubitril Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sacubitril Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Sacubitril Sodium USDMF includes data on Sacubitril Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sacubitril Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sacubitril Sodium suppliers with USDMF on PharmaCompass.
A Sacubitril Sodium written confirmation (Sacubitril Sodium WC) is an official document issued by a regulatory agency to a Sacubitril Sodium manufacturer, verifying that the manufacturing facility of a Sacubitril Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sacubitril Sodium APIs or Sacubitril Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Sacubitril Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Sacubitril Sodium 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 Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sacubitril Sodium 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 Sodium 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 Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sacubitril Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sacubitril Sodium suppliers with NDC on PharmaCompass.
Sacubitril Sodium 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 Sodium 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 Sodium GMP manufacturer or Sacubitril Sodium GMP API supplier for your needs.
A Sacubitril Sodium CoA (Certificate of Analysis) is a formal document that attests to Sacubitril Sodium's compliance with Sacubitril Sodium specifications and serves as a tool for batch-level quality control.
Sacubitril Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Sacubitril Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Sacubitril Sodium EP), Sacubitril Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sacubitril Sodium USP).