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1. 3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate
2. Lcz 696
3. Lcz-696
4. Lcz696
5. Sacubitril And Valsartan Drug Combination
6. Sacubitril And Valsartan Sodium Anhydrous Drug Combination
7. Sacubitril And Valsartan Sodium Hydrate Drug Combination
8. Sacubitril Valsartan Drug Combination
9. Sacubitril Valsartan Sodium Anhydrous
10. Sacubitril Valsartan Sodium Hydrate
11. Sacubitril-valsartan
12. Sacubitril-valsartan Sodium Anhydrous Drug Combination
13. Sacubitril-valsartan Sodium Hydrate Drug Combination
14. Trisodium (3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate) Hemipentahydrate
1. Sacubitril Valsartan Sodium Hydrate
2. Sacubitril Mixture With Valsartan
3. Wb8ft61183
4. Lcz 696
5. Sacubitril Valsartan Sodium Hydrate (jan)
6. Sacubitril Valsartan Sodium Hydrate [jan]
7. Entresto (tn)
8. Unii-wb8ft61183
9. Valsartan Mixture With Ahu-377
10. Ex-a2849
11. Mfcd29477717
12. 3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate
13. Ac-29037
14. Sucabitril Valsartan Sodium Hydrate
15. Trisodium (3-(1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate) Hemipentahydrate
16. D10226
17. Valsartan Ahu-377 Sodium Hemipentahydrate
18. Q27292546
19. L-valine, N-(1-oxopentyl)-n-((2'-(2h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Compd. With .alpha.-ethyl (.alpha.r,.gamma.s)-.gamma.-((3-carboxy-1-oxopropyl)amino)-.alpha.-methyl(1,1'-biphenyl)-4-pentanoate, Sodium Salt, Hydrate (2:2:6:5)
20. L-valine, N-(1-oxopentyl)-n-((2'-(2h-tetrazol-5-yl)(1,1'-biphenyl)-4-yl)methyl)-, Compd. With Alpha-ethyl(alphar,gammas)-gamma-((3-carboxy-1-oxopropyl)amino)-alpha-methyl(1,1'-biphenyl)-4-pentanoate, Sodium Salt, Hydrate (2:2:6:5)
| Molecular Weight | 1916.0 g/mol |
|---|---|
| Molecular Formula | C96H120N12Na6O21 |
| Hydrogen Bond Donor Count | 7 |
| Hydrogen Bond Acceptor Count | 29 |
| Rotatable Bond Count | 40 |
| Exact Mass | 1915.8110694 g/mol |
| Monoisotopic Mass | 1914.8077146 g/mol |
| Topological Polar Surface Area | 396 Ų |
| Heavy Atom Count | 135 |
| Formal Charge | 0 |
| Complexity | 1140 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 15 |
Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.
Angiotensin Receptor Antagonists
Agents that antagonize ANGIOTENSIN RECEPTORS. Many drugs in this class specifically target the ANGIOTENSIN TYPE 1 RECEPTOR. (See all compounds classified as Angiotensin Receptor Antagonists.)
C09DX04
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registrant Name : Sangjin Trading Co., Ltd.
Registration Date : 2022-04-25
Registration Number : Su583-30-ND
Manufacturer Name : Dr. Reddy\'s Laboratories Limited@M/s Chromo Laboratories India Pvt Ltd.@Dr. Reddy\'s Laboratories Limited
Manufacturer Address : CTO-SEZ Process Unit-01, Sector No.\'s 28 to 34, 36 to 37, 40, 50 to 53, Survey No.\'s 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District 532409, Andhra Pradesh, India@Plot 43 & 44, IDA, Phase-II, PASHAMYLARAM, PATANCHERU, SANGAREDDY, PASHAMYLARAM(V), PATANCHERU(M), SANGAREDDY(DIST.), 502307, India@CTO-VI, APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh – 532 409 India
| Available Reg Filing : CDMF |
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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 : Active
Type : II
Registrant Name : Lihu Healthcare Co., Ltd.
Registration Date : 2023-01-27
Registration Number : Su382-8-ND
Manufacturer Name : Mankind Pharma Limited@Shree Jee Laboratory Private Limited
Manufacturer Address : 208, Okhla Industrial Estate, Phase-3, New Delhi-110020, India@C-24 &25, RIICO Industrial Area, Sotanala, Behror - 301701, Dist. Alwar (Rajasthan), India
| Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37994
Submission : 2023-03-09
Status : Active
Type : II
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-09-28
Registration Number : Su434-48-ND
Manufacturer Name : Ami Lifesciences Private Limited @Smilax Laboratories Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India@Plot No. 70&71, JNPharmacity, Parawada(M), Visakhapatnam - 531021, Andhra Pradesh, India
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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(R) -tert-butyl-((1,1’-biphenyl)-4-yl-3-hydropan...
CAS Number : 1426129-50-1
End Use API : Sacubitril-Valsartan
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...

(S) -5-((biphenyl-4-yl)methyl)pyrroidine-2-ketone
CAS Number : 1038924-61-6
End Use API : Sacubitril-Valsartan
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...

(S)-5-(biphenyl-4-(tert butoxyl carbonyl)amino-2-m...
CAS Number : 1012341-50-2
End Use API : Sacubitril-Valsartan
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...

(2R,4S)-4-amino-5-(biphenyl-4-yl)-2-methylpentanoi...
CAS Number : 149690-12-0
End Use API : Sacubitril-Valsartan
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...

(2e,4r)-5-(1, 1 '-biphenyl)-4-yl-4-(((1, 1 -dimeth...
CAS Number : 1012341-48-8
End Use API : Sacubitril-Valsartan
About The Company : Founded in 2003, Senary Chem is one of the Key High-Tech Enterprises of National Torch Plan. Senary located in National Cangzhou Lingang Economic and Technologi...

Sacubitril Hemicalcium
CAS Number : 1369773-39-6
End Use API : Sacubitril-Valsartan
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

(R)-tert-butyl (1-([1,1'-biphenyl]-4-yl)-3-hydroxy...
CAS Number : 1426129-50-1
End Use API : Sacubitril-Valsartan
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxyca...
CAS Number : 1012341-50-2
End Use API : Sacubitril-Valsartan
About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

CAS Number : 149690-12-0
End Use API : Sacubitril-Valsartan
About The Company : Shanghai Stepuppharm has a strong technical development troop and most of our technological backbone are Senior R&D persons and have more than 10 years experien...

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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Sacubitril / Valsartan
Dosage Form : Oral
Dosage Strength : 24 / 26 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Sacubitril / Valsartan
Dosage Form : Oral
Dosage Strength : 49 / 51 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info :
Registration Country : India
Brand Name : Sacubitril / Valsartan
Dosage Form : Oral
Dosage Strength : 97 / 103 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Sacubitril ; Valsartan
Dosage Form : Film-Coated Tablet
Dosage Strength : 24;26MG;MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Sacubitril ; Valsartan
Dosage Form : Film-Coated Tablet
Dosage Strength : 49;51MG;MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name : Sacubitril ; Valsartan
Dosage Form : Film-Coated Tablet
Dosage Strength : 97;103MG;MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info : Dossier Readiness: Q2 2026
Registration Country : Latvia
Brand Name :
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Readiness: Q2 2026
Registration Country : Latvia
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sacubitril-Valsartan
Dosage Form : DC Granules
Dosage Strength : 24; 26MG; MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sacubitril-Valsartan
Dosage Form : DC Granules
Dosage Strength : 49; 51MG; MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Sacubitril-Valsartan
Dosage Form : DC Granules
Dosage Strength : 97; 103MG; MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Regulatory Info : Approved
Registration Country : Sweden
Sacubitril Sodium|Valsartan Disodium
Brand Name : Sacubitril/Valsartan Accord
Dosage Form : Film Coated Tablet
Dosage Strength : 24mg;26mg
Packaging :
Approval Date : 14/07/2025
Application Number : 20231127000046
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Sacubitril Sodium|Valsartan Disodium
Brand Name : Sacubitril/Valsartan Accord
Dosage Form : Film Coated Tablet
Dosage Strength : 97mg;103mg
Packaging :
Approval Date : 14/07/2025
Application Number : 20231127000060
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Sacubitril Sodium|Valsartan Disodium
Brand Name : Sakubitril/Valsartan Devatis
Dosage Form : Film Coated Tablet
Dosage Strength : 24mg;26mg
Packaging :
Approval Date : 14/07/2025
Application Number : 20231127000015
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Sacubitril Sodium|Valsartan Disodium
Brand Name : Sakubitril/Valsartan Devatis
Dosage Form : Film Coated Tablet
Dosage Strength : 97mg;103mg
Packaging :
Approval Date : 14/07/2025
Application Number : 20231127000039
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Entresto
Dosage Form : Film Coated Tablet
Dosage Strength : 24.3mg;25.7mg
Packaging :
Approval Date : 17/09/2015
Application Number : 65673
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Entresto
Dosage Form : Film Coated Tablet
Dosage Strength : 97.2mg;102.8mg
Packaging :
Approval Date : 17/09/2015
Application Number : 65673
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Entresto mg
Dosage Form : Granules
Dosage Strength : 6mg;6mg
Packaging :
Approval Date : 21/08/2024
Application Number : 69255
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Approved
Registration Country : Sweden
Sakubitril-Valsartannatriumhydrat
Brand Name : Entresto
Dosage Form : Capsule
Dosage Strength : 15mg/16mg
Packaging :
Approval Date : 26/05/2023
Application Number : 20220620000028
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Sakubitril-Valsartannatriumhydrat
Brand Name : Entresto
Dosage Form : Film Coated Tablet
Dosage Strength : 24mg;26mg
Packaging :
Approval Date : 19/11/2015
Application Number : 20141220000037
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Sakubitril-Valsartannatriumhydrat
Brand Name : Entresto
Dosage Form : Film Coated Tablet
Dosage Strength : 97mg;103mg
Packaging :
Approval Date : 19/11/2015
Application Number : 20141220000051
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Prescription
Registration Country : Canada
SACUBITRIL (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX)
Brand Name : ENTRESTO
Dosage Form : TABLET
Dosage Strength : 24MG
Packaging : 30
Approval Date :
Application Number : 2446928
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
SACUBITRIL (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX)
Brand Name : ENTRESTO
Dosage Form : TABLET
Dosage Strength : 49MG
Packaging : 60
Approval Date :
Application Number : 2446936
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
SACUBITRIL (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX)
Brand Name : ENTRESTO
Dosage Form : TABLET
Dosage Strength : 97MG
Packaging : 60
Approval Date :
Application Number : 2446944
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
SACUBITRIL (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX)
Brand Name : SANDOZ SACUBITRIL-VALSARTAN
Dosage Form : TABLET
Dosage Strength : 24MG
Packaging :
Approval Date :
Application Number : 2549018
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
SACUBITRIL (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX)
Brand Name : SANDOZ SACUBITRIL-VALSARTAN
Dosage Form : TABLET
Dosage Strength : 49MG
Packaging :
Approval Date :
Application Number : 2549026
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
SACUBITRIL (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX)
Brand Name : SANDOZ SACUBITRIL-VALSARTAN
Dosage Form : TABLET
Dosage Strength : 97MG
Packaging :
Approval Date :
Application Number : 2549034
Regulatory Info : Prescription
Registration Country : Canada

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Registration Country : South Africa
Sacubitril valsartan sodium hydrate
Brand Name : Entresto 50mg
Dosage Form : FCT
Dosage Strength : 50mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Sacubitril valsartan sodium hydrate
Brand Name : Entresto 100mg
Dosage Form : FCT
Dosage Strength : 100mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Sacubitril valsartan sodium hydrate
Brand Name : Entresto 100mg
Dosage Form : FCT
Dosage Strength : 100mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Sacubitril valsartan sodium hydrate
Brand Name : Entresto 200mg
Dosage Form : FCT
Dosage Strength : 200mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Website
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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.
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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).