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1. Lercadip
2. Lercanidipine Hydrochloride
3. Lerdip
4. Methyl-1,1-dimethyl-2-(n-(3,3-diphenylpropyl)-n-methylamino)ethyl-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
5. Rec 15-2375
6. Rec-15-2375
7. Zanidip
1. 100427-26-7
2. Lercanidipine [inn]
3. Lercanil
4. Lercanidipine (inn)
5. V7xtj4r0bh
6. Masnidipine
7. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 3-[2-[(3,3-diphenylpropyl)methylamino]-1,1-dimethylethyl] 5-methyl Ester
8. 5-o-[1-[3,3-diphenylpropyl(methyl)amino]-2-methylpropan-2-yl] 3-o-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
9. 1-[(3,3-diphenylpropyl)(methyl)amino]-2-methylpropan-2-yl Methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
10. 3-(1-((3,3-diphenylpropyl)(methyl)amino)-2-methylpropan-2-yl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
11. 3-{1-[(3,3-diphenylpropyl)(methyl)amino]-2-methylpropan-2-yl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
12. Lercanil (tn)
13. Ncgc00167492-01
14. Unii-v7xtj4r0bh
15. Lercanidipine [inn:ban]
16. Lercanadipine
17. 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic Acid O5-[1-[3,3-diphenylpropyl(methyl)amino]-2-methylpropan-2-yl] Ester O3-methyl Ester
18. Lercanidipine [mi]
19. Schembl25268
20. Lercanidipine [who-dd]
21. Chembl250270
22. Schembl6846222
23. Dtxsid2048327
24. Chebi:135930
25. Hms3604g05
26. Bcp21318
27. Hy-b0612
28. Bbl029074
29. S5861
30. Stk639861
31. Akos005571238
32. Db00528
33. Sdccgsbi-0633690.p001
34. Ncgc00167492-02
35. Ncgc00167492-11
36. (+-)-2-((3,3-diphenylpropyl)methylamino)-1,1-dimethylethyl Methyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate
37. Ac-15409
38. As-75252
39. Ft-0631006
40. C13971
41. D08111
42. 427l267
43. A800200
44. A929939
45. Q410492
46. Sr-01000884000
47. Sr-01000884000-1
48. [2-oxo-3-(3-trifluoromethyl-phenoxy)-propyl]-phosphonic
49. 2-((3,3-diphenylpropyl)methylamino)-1,1-dimethylethyl Methyl (4rs)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
50. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 2-((3,3-diphenylpropyl)methylamino)-1,1-dimethylethyl Methyl Ester
51. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 2-(3,3-diphenylpropyl)methylamino)-1,1-dimethylethyl Methyl Ester
52. O5-[1-[3,3-diphenylpropyl(methyl)amino]-2-methyl-propan-2-yl] O3-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
| Molecular Weight | 611.7 g/mol |
|---|---|
| Molecular Formula | C36H41N3O6 |
| XLogP3 | 6.9 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 13 |
| Exact Mass | 611.29953604 g/mol |
| Monoisotopic Mass | 611.29953604 g/mol |
| Topological Polar Surface Area | 114 Ų |
| Heavy Atom Count | 45 |
| Formal Charge | 0 |
| Complexity | 1090 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
For the treatment of Hypertension, management of angina pectoris and Raynaud's syndrome
Lercanidipine, a dihydropyridine calcium-channel blocker, is used alone or with an angiotensin-converting enzyme inhibitor, to treat hypertension, chronic stable angina pectoris, and Prinzmetal's variant angina. Lercanidipine is similar to other peripheral vasodilators. Lercanidipine inhibits the influx of extra cellular calcium across the myocardial and vascular smooth muscle cell membranes possibly by deforming the channel, inhibiting ion-control gating mechanisms, and/or interfering with the release of calcium from the sarcoplasmic reticulum. The decrease in intracellular calcium inhibits the contractile processes of the myocardial smooth muscle cells, causing dilation of the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased total peripheral resistance, decreased systemic blood pressure, and decreased afterload.
Antihypertensive Agents
Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)
Calcium Channel Blockers
A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)
C08CA13
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
C - Cardiovascular system
C08 - Calcium channel blockers
C08C - Selective calcium channel blockers with mainly vascular effects
C08CA - Dihydropyridine derivatives
C08CA13 - Lercanidipine
By deforming the channel, inhibiting ion-control gating mechanisms, and/or interfering with the release of calcium from the sarcoplasmic reticulum, Lercanidipine inhibits the influx of extracellular calcium across the myocardial and vascular smooth muscle cell membranes The decrease in intracellular calcium inhibits the contractile processes of the myocardial smooth muscle cells, causing dilation of the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased total peripheral resistance, decreased systemic blood pressure, and decreased afterload.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35507
Submission : 2020-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35609
Submission : 2021-01-30
Status : Active
Type : II
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0099
Start Marketing Date : 2013-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2015-03-30
Registration Number : 20101130-128-H-34-05(3)
Manufacturer Name : SUN Pharmaceutical Industries Limited
Manufacturer Address : A-7/A-8, MIDC ,Industrial Area, Ahmednagar-414 111, Maharashtra, India
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Average Price (USD/KGS) |
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PharmaCompass offers a list of Lercanidipine 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 Lercanidipine manufacturer or Lercanidipine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lercanidipine manufacturer or Lercanidipine supplier.
PharmaCompass also assists you with knowing the Lercanidipine API Price utilized in the formulation of products. Lercanidipine API Price is not always fixed or binding as the Lercanidipine Price is obtained through a variety of data sources. The Lercanidipine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lercanidipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lercanidipine, including repackagers and relabelers. The FDA regulates Lercanidipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lercanidipine 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 Lercanidipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lercanidipine supplier is an individual or a company that provides Lercanidipine active pharmaceutical ingredient (API) or Lercanidipine finished formulations upon request. The Lercanidipine suppliers may include Lercanidipine API manufacturers, exporters, distributors and traders.
click here to find a list of Lercanidipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lercanidipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Lercanidipine active pharmaceutical ingredient (API) in detail. Different forms of Lercanidipine DMFs exist exist since differing nations have different regulations, such as Lercanidipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lercanidipine DMF submitted to regulatory agencies in the US is known as a USDMF. Lercanidipine USDMF includes data on Lercanidipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lercanidipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lercanidipine 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 Lercanidipine Drug Master File in Korea (Lercanidipine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lercanidipine. The MFDS reviews the Lercanidipine KDMF as part of the drug registration process and uses the information provided in the Lercanidipine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lercanidipine 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 Lercanidipine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lercanidipine suppliers with KDMF on PharmaCompass.
A Lercanidipine written confirmation (Lercanidipine WC) is an official document issued by a regulatory agency to a Lercanidipine manufacturer, verifying that the manufacturing facility of a Lercanidipine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lercanidipine APIs or Lercanidipine finished pharmaceutical products to another nation, regulatory agencies frequently require a Lercanidipine WC (written confirmation) as part of the regulatory process.
click here to find a list of Lercanidipine 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 Lercanidipine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lercanidipine 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 Lercanidipine 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 Lercanidipine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lercanidipine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lercanidipine suppliers with NDC on PharmaCompass.
Lercanidipine 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 Lercanidipine 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 Lercanidipine GMP manufacturer or Lercanidipine GMP API supplier for your needs.
A Lercanidipine CoA (Certificate of Analysis) is a formal document that attests to Lercanidipine's compliance with Lercanidipine specifications and serves as a tool for batch-level quality control.
Lercanidipine CoA mostly includes findings from lab analyses of a specific batch. For each Lercanidipine 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.
Lercanidipine may be tested according to a variety of international standards, such as European Pharmacopoeia (Lercanidipine EP), Lercanidipine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lercanidipine USP).
