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1. 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic Acid
2. Esp-55016
3. Esp55016
4. Etc-1002
5. Nexletol
6. Nilemdo
1. Etc-1002
2. 738606-46-7
3. 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic Acid
4. Nexletol
5. Esp-55016
6. Nilemdo
7. Etc1002
8. Etc 1002
9. Esp 55016
10. 1ej6z6q368
11. Mfcd18800820
12. Etc-1002;esp-55016
13. Pentadecanedioic Acid, 8-hydroxy-2,2,14,14-tetramethyl-
14. Bempedoate
15. Unii-1ej6z6q368
16. Bempedoic Acid [usan:inn]
17. Bempedoic-acid
18. Bempedoic Acid
19. Esp-55016
20. Acido Bempedoico
21. Acide Bempedoique
22. Acidum Bempedoicum
23. Nexletol (tn)
24. Bempedoic Acid (usan/inn)
25. Bempedoic Acid [inn]
26. Bempedoic Acid [jan]
27. Bempedoic Acid [usan]
28. Schembl185768
29. Gtpl8321
30. Bempedoic Acid [who-dd]
31. Chembl3545313
32. Chebi:149601
33. Dtxsid401027952
34. Amy31933
35. Bcp16083
36. Esp55016
37. Ex-a1243
38. Zinc3948738
39. Bempedoic Acid [orange Book]
40. S7953
41. Akos027439916
42. Ccg-267969
43. Cs-3952
44. Db11936
45. Nexlizet Component Bempedoic Acid
46. Ac-29040
47. As-49804
48. Hy-12357
49. Sy244715
50. Bempedoic Acid Component Of Nexlizet
51. Bempedoic Acid(etc-1002;esp-55016)
52. Db-108321
53. D10691
54. N10681
55. A905695
56. Q27075007
57. 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic Acid;etc-1002
| Molecular Weight | 344.5 g/mol |
|---|---|
| Molecular Formula | C19H36O5 |
| XLogP3 | 4.8 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 14 |
| Exact Mass | 344.25627424 g/mol |
| Monoisotopic Mass | 344.25627424 g/mol |
| Topological Polar Surface Area | 94.8 Ų |
| Heavy Atom Count | 24 |
| Formal Charge | 0 |
| Complexity | 351 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease that warrants additional lowering of LDL-C. The combination of bempedoic and ezetimibe is also indicated with diet management and maximally tolerated statin therapy to treat elevated LDL-C levels in adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease who require further lowering of LDL-C.
FDA Label
Nilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4. 2, 4. 3, and 4. 4) or,
- alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.
Bempedoic acid inhibits the synthesis of cholesterol in the liver, reducing LDL-C levels. This reduces the development of atherosclerotic plaques that may increase the risk of cardiovascular events. Earlier clinical trials studying the effects of bempedoic acid showed a dosedependent reduction of LDLC levels in addition to decreased LDL particle number, and reduced levels of apolipoprotein B, nonHDL cholesterol, and highsensitivity Creactive protein. Due to its unique mechanism of action, bempedoic acid is not associated with myositis, an adverse effect that frequently accompanies statin therapy. More recent trials have supported that this drug significantly decreases LDL-C levels after 12 weeks of therapy and provides additional lowering of LDL-C when combined with ezetimibe and statin therapy. The effects of bempedoic acid on mortality are currently unknown.
Enzyme Inhibitors
Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
Hypolipidemic Agents
Substances that lower the levels of certain LIPIDS in the BLOOD. They are used to treat HYPERLIPIDEMIAS. (See all compounds classified as Hypolipidemic Agents.)
C10AX
C - Cardiovascular system
C10 - Lipid modifying agents
C10A - Lipid modifying agents, plain
C10AX - Other lipid modifying agents
C10AX15 - Bempedoic acid
Absorption
Bempedoic acid is rapidly absorbed in the small intestine. The Tmax of the 180mg tablet is estimated at 3.5 hours.
Route of Elimination
Bempedoic acid's conjugates are primarily eliminated via the urine (70%) and the feces (30%). A total of 5% of the unchanged drug is excreted in the urine and feces, combined.
Volume of Distribution
The apparent volume of distribution of bempedoic acid is about 18L.
Clearance
The clearance (CL/F) of bempedoic acid at steady state was estimated at 11.2 mL/min during clinical trials.
The two main metabolites of bempedoic metabolism are ETC-1002-CoA and ESP15228. Bempedoic acid is primarily eliminated via the metabolism of its acyl glucuronide. This drug is reversibly converted to an active metabolite (ESP15228) based on observations during in vitro studies. Both compounds resulting from the metabolism of bempedoic acid are metabolized to become inactive glucuronide conjugates by the enzyme UGT2B7.
The half-life of bempedoic acid ranges between 15 and 24 hours. Prescribing information indicates a clearance of 21 hours +/- 11 hours.
Normally, LDL cholesterol is produced in the liver and circulates in the blood. When the blood becomes saturated, excess LDL deposits in blood vessels including the coronary arteries, increasing the risk of cardiovascular events. Bempedoic acid is a prodrug that requires activation in the liver. The very-long-chain acyl-CoA synthetase-1 (ACSVL1) enzyme is responsible for its activation to ETC-1002-CoA, the pharmacologically active metabolite. ATP lyase (also known as ATP synthase) plays an important part of cholesterol synthesis. BETC-1002-CoA directly inhibits this enzyme after the parent drug is activated in the liver by coenzyme A (CoA). This inhibition leads to upregulation of the LDL cholesterol receptor, reducing serum LDL-C via increased uptake and LDL clearance in the liver. By the above mechanisms, bempedoic acid causes a total decrease of circulating LDL-C that normally damages blood vessels and leads to atherosclerosis. Lastly, ETC-1002 activates AMP-activated protein kinase (AMPK) in rodents, which inhibits the synthesis of cholesterol via the inhibition of HMG-CoA reductase. The relevance of this to humans is unknown.
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DMF Number : 38786
Submission : 2023-12-28
Status : Active
Type : II
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DMF Review : Reviewed
Rev. Date : 2023-11-07
Pay. Date : 2023-09-22
DMF Number : 36085
Submission : 2021-07-05
Status : Active
Type : II
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-039
Start Marketing Date : 2021-07-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
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DMF Review : Reviewed
Rev. Date : 2023-07-28
Pay. Date : 2023-06-27
DMF Number : 36933
Submission : 2022-03-31
Status : Active
Type : II
NDC Package Code : 71796-049
Start Marketing Date : 2022-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Submission : 2022-10-03
Status : Active
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Drugs in Development
Details:
Nilemdo(bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor approved in EU for the treatment of heart attack, hypercholesterolaemia & cardiovascular diseases.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nilemdo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2024
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
NILEMDO® and NUSTENDI® Approved in Europe for Lowering LDL Cholesterol
Details : Nilemdo(bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor approved in EU for the treatment of heart attack, hypercholesterolaemia & cardiovascular diseases.
Brand Name : Nilemdo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 22, 2024
Details:
Nexletol(bempedoic acid) is an adenosine triphosphate-citrate lyase inhibitor indicated as an adjunct to diet and statin therapy for heart attack, hypercholesterolaemia & cardiovascular diseases.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nexletol
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2024
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks
Details : Nexletol(bempedoic acid) is an adenosine triphosphate-citrate lyase inhibitor indicated as an adjunct to diet and statin therapy for heart attack, hypercholesterolaemia & cardiovascular diseases.
Brand Name : Nexletol
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2024
Details:
Nilemdo(bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet and statin therapy for heart attack, hypercholesterolaemia & cardiovascular diseases.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nilemdo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2024
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
CHMP Issues Positive Opinions for Bempedoic Acid and Combination Tablet
Details : Nilemdo(bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet and statin therapy for heart attack, hypercholesterolaemia & cardiovascular diseases.
Brand Name : Nilemdo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2024
Details:
The collaboration combines Esperion Therapeutics’ NILEMDO (bempedoic acid), an ACL inhibitor, with Daiichi Sankyo’s commercial capabilities for cardiovascular medicines.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nilemdo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Daiichi Sankyo
Deal Size: $1,255.0 million Upfront Cash: $30.0 million
Deal Type: Collaboration January 03, 2024
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Daiichi Sankyo
Deal Size : $1,255.0 million
Deal Type : Collaboration
Esperion and Daiichi Sankyo Amend $125M Collaboration, Resolve Litigation
Details : The collaboration combines Esperion Therapeutics’ NILEMDO (bempedoic acid), an ACL inhibitor, with Daiichi Sankyo’s commercial capabilities for cardiovascular medicines.
Brand Name : Nilemdo
Molecule Type : Small molecule
Upfront Cash : $30.0 million
January 03, 2024
Details:
Bempedoic acid (commercialised in the European Economic Area, Turkey and Switzerland as NILEMDO®) is a first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nilemdo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2023
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Bempedoic acid (commercialised in the European Economic Area, Turkey and Switzerland as NILEMDO®) is a first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.
Brand Name : Nilemdo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 26, 2023
Details:
Nilemdo (bempedoic acid) is indicated as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nilemdo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2023
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Nilemdo (bempedoic acid) is indicated as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional loweri...
Brand Name : Nilemdo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 23, 2023
Details:
Nexletol (bempedoic acid) is indicated as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nexletol
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Nexletol (bempedoic acid) is indicated as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lower...
Brand Name : Nexletol
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2022
Details:
Bempedoic acid (commercialised in the European Economic Area, Turkey and Switzerland as NILEMDO®▼) is a first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even further.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nilemdo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Bempedoic acid (commercialised in the European Economic Area, Turkey and Switzerland as NILEMDO®▼) is a first-in-class, oral treatment which lowers cholesterol, and which can be combined with other oral treatments to help lower cholesterol even furthe...
Brand Name : Nilemdo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 08, 2022
Details:
NEXLETOL (bempedoic acid) is indicated as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Nexletol
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Esperion Announces CLEAR Cardiovascular Outcomes Trial of NEXLETOL
Details : NEXLETOL (bempedoic acid) is indicated as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lower...
Brand Name : Nexletol
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 07, 2022
Details:
Brillo (Bempedoic Acid) is a first-in-class drug which has a new mechanism of action compared to the currently available lipid-lowering agents, It is administered as a 180-mg dose, is approved by the US FDA.
Lead Product(s): Bempedoic Acid
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Brillo
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Lead Product(s) : Bempedoic Acid
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Sun Pharma to Launch First-In-Class Oral Lipid-Lowering Drug in India
Details : Brillo (Bempedoic Acid) is a first-in-class drug which has a new mechanism of action compared to the currently available lipid-lowering agents, It is administered as a 180-mg dose, is approved by the US FDA.
Brand Name : Brillo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 18, 2022
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Shandong Boyuan is a Chinese manufacturer of GMP & CEP APIs & pharmaceutical intermediates.
ethyl-2,2-dimethyl-7-bromoheptanoate
CAS Number : 123469-92-1
End Use API : Bempedoic Acid
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
Shandong Boyuan is a Chinese manufacturer of GMP & CEP APIs & pharmaceutical intermediates.
2,2,14,14-tetramethyl-8-oxopentadecanedioic acid d...
CAS Number : 738606-43-4
End Use API : Bempedoic Acid
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
Shandong Boyuan is a Chinese manufacturer of GMP & CEP APIs & pharmaceutical intermediates.
2,2,14,14-Tetramethyl-8-oxopentadecanedioic acid
CAS Number : 413624-71-2
End Use API : Bempedoic Acid
About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 36635-61-7
End Use API : Bempedoic Acid
About The Company : Headquartered in Fengxian District, Shanghai Minbiotch Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Ethyl-2,2-dimethyl-7-bromoheptanoate
CAS Number : 123469-92-1
End Use API : Bempedoic Acid
About The Company : Headquartered in Fengxian District, Shanghai Minbiotch Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates...
2,2,14,14-TETRAMETHYL-8-OXOPENTADECANEDIOIC ACID
CAS Number : 413624-71-2
End Use API : Bempedoic Acid
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-Nat...
2,2,14,14,-TETRAMETHYL-8-OXOPENTADECANEDIOIC ACID ...
CAS Number : 738606-43-4
End Use API : Bempedoic Acid
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-Nat...
TOSMIC(TOLUENESULFONYL METHYL ISOCYANIDE
CAS Number : 36635-61-7
End Use API : Bempedoic Acid
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-Nat...
CAS Number : 97-62-1
End Use API : Bempedoic Acid
About The Company : Litmus Organics Pvt. Ltd., established in 2005, aims to be a leading chemical manufacturer in India. Equipped with the latest technology and testing facilities,...
p-Toluenesulfonylmethyl Isocyanide (TosMIC)
CAS Number : 36635-61-7
End Use API : Bempedoic Acid
About The Company : Sanpra Synthesis strongly believes that with its expertise and innovative pharmaceutical business background, it is aptly positioned for APIs and intermediates ...
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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Dosage Strength : 180MG
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Dosage Form : Oral Solid Dosage Form
Dosage Strength : 120MG
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Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Registration Country : India
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Dosage Form : Oral Solid Dosage Form
Dosage Strength : 240MG
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Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Registration Country : India
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Dosage Form : Oral Solid Dosage Form
Dosage Strength : 180MG; 10MG
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Regulatory Info : Lead Market Dossiers- Under Development
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 : EU-CTD Dossier: Q3.2026
Registration Country : Hungary
Brand Name :
Dosage Form : Film-coated tablet
Dosage Strength : 180MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU-CTD Dossier: Q3.2026
Registration Country : Hungary
Regulatory Info :
Registration Country : Switzerland
Brand Name : Nilemdo
Dosage Form : Filmtablet
Dosage Strength : 180mg
Packaging :
Approval Date :
Application Number :
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Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Nustendi
Dosage Form : Filmtabl
Dosage Strength : 180/10mg
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Application Number :
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Registration Country : Switzerland
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Registration Country : Switzerland
Brand Name : Nustendi
Dosage Form : Film-Coated Tablets
Dosage Strength : 180/10mg
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Registration Country : Switzerland
Regulatory Info : RX
Registration Country : USA
Brand Name : NEXLETOL
Dosage Form : TABLET;ORAL
Dosage Strength : 180MG
Packaging :
Approval Date : 2020-02-21
Application Number : 211616
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : NEXLIZET
Dosage Form : TABLET;ORAL
Dosage Strength : 180MG;10MG
Packaging :
Approval Date : 2020-02-26
Application Number : 211617
Regulatory Info : RX
Registration Country : USA
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