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Ivabradine Hydrochloride

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Synopsis

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Chemistry

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Also known as: 148849-67-6, Ivabradine hcl, Procoralan, Corlentor, Corlanor, Ivabradine (hydrochloride)

Molecular Formula

C₂₇H₃₇ClN₂O₅

Molecular Weight

505.0 g/mol

InChI Key

HLUKNZUABFFNQS-ZMBIFBSDSA-N

FDA UNII

TP19837BZK

A benzazepine derivative and selective HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNELS inhibitor that lowers the heart rate. It is used in the treatment of CHRONIC STABLE ANGINA in patients unable to take BETA-ADRENERGIC BLOCKERS, and in the treatment of HEART FAILURE.

1 2D Structure

Ivabradine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

3-[3-[[(7S)-3,4-dimethoxy-7-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1H-3-benzazepin-4-one;hydrochloride

2.1.2 InChI

InChI=1S/C27H36N2O5.ClH/c1-28(17-21-11-20-14-25(33-4)26(34-5)16-22(20)21)8-6-9-29-10-7-18-12-23(31-2)24(32-3)13-19(18)15-27(29)30;/h12-14,16,21H,6-11,15,17H2,1-5H3;1H/t21-;/m1./s1

2.1.3 InChI Key

HLUKNZUABFFNQS-ZMBIFBSDSA-N

2.1.4 Canonical SMILES

CN(CCCN1CCC2=CC(=C(C=C2CC1=O)OC)OC)CC3CC4=CC(=C(C=C34)OC)OC.Cl

2.1.5 Isomeric SMILES

CN(CCCN1CCC2=CC(=C(C=C2CC1=O)OC)OC)C[C@H]3CC4=CC(=C(C=C34)OC)OC.Cl

2.2 Other Identifiers

2.2.1 UNII

TP19837BZK

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 7,8-dimethoxy-3-(3-(((4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2h-benzazepin-2-one

2. Corlanor

3. Ivabradine

4. S 16257

5. S 16257 2

6. S 16257-2

7. S 162572

8. S 16260 2

9. S 16260-2

10. S 162602

11. S-16257

12. S-16257-2

13. S-16260-2

14. S16257

15. S162572

16. S162602

2.3.2 Depositor-Supplied Synonyms

1. 148849-67-6

2. Ivabradine Hcl

3. Procoralan

4. Corlentor

5. Corlanor

6. Ivabradine (hydrochloride)

7. Tp19837bzk

8. (s)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-1,3,4,5-tetrahydro-2h-benzo[d]azepin-2-one Hydrochloride

9. Ivabradine Hydrochloride [usan]

10. Chebi:85969

11. Amg 998

12. Amg-998

13. S-16257-2

14. 2h-3-benzazepin-2-one, 3-[3-[[[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-, Hydrochloride (1:1)

15. Ncgc00181343-01

16. 148849-67-6 (hcl)

17. (s)-3-(3-(((3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-dihydro-1h-benzo[d]azepin-2(3h)-one Hydrochloride

18. 3-[3-[[[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-7,8-dimethoxy-2h-3-benzazepin-2-one Hydrochloride

19. Ivabradinehydrochloride

20. Ivabradine Hcl (procoralan)

21. S16257

22. Unii-tp19837bzk

23. Corlentor (tn)

24. Corlanor (tn)

25. 2h-3-benzazepin-2-one, 3-(3-((((7s)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, Hydrochloride (1:1)

26. 3-(3-((((7s)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-2h-3-benzazepin-2-one Hydrochloride

27. Coralan (tn)

28. Ivabrandine Hydrochloride

29. Ivabradine Monohydrochloride

30. Dsstox_cid_26913

31. Dsstox_rid_82011

32. Dsstox_gsid_46913

33. Schembl23470

34. Mls006010110

35. Ivabradine Hydrochloride- Bio-x

36. Chembl2145077

37. Dtxsid2046913

38. Hy-b0162a

39. 3-[3-[[(7s)-3,4-dimethoxy-7-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1h-3-benzazepin-4-one;hydrochloride

40. Bcp05218

41. Tox21_112802

42. Ac-543

43. Ivabradine Hydrochloride (jan/usan)

44. Ivabradine Hydrochloride [mi]

45. Mfcd00929899

46. S2086

47. Ivabradine Hydrochloride [jan]

48. Akos015849582

49. Akos016002249

50. Bcp9000798

51. Ccg-269739

52. Cs-1994

53. Gs-3584

54. Ivabradine Hydrochloride [who-dd]

55. (7,8-dimethoxy 3-(3-(((1s)-(4,5-dimethoxybenzocyclobutan-1-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-2h-benzazepin-2-one Hydrochloride

56. (s)-3-(3-(((4,5-dimethoxy-1,2-dihydrocyclobutabenzen-1-yl)methyl)(methyl)amino)propyl)-7,8-dimethoxy-4,5-dihydro-1h-benzo[d]azepin-2(3h)-one Hydrochloride

57. Bi164596

58. Smr004701246

59. Ivabradine Hydrochloride [ema Epar]

60. Ivabradine Hydrochloride, >=98% (hplc)

61. Am20090729

62. B1360

63. Cas-148849-67-6

64. I0847

65. Ivabradine Hydrochloride [orange Book]

66. D08095

67. 974i008

68. J-008523

69. J-521616

70. Q27158823

71. (+)-s16257

72. 2h-3-benzazepin-2-one, 3-(3-((((7s)-3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, Monohydrochloride

73. 2h-3-benzazepin-2-one, 3-(3-(((3,4-dimethoxybicyclo(4.2.0)octa-1,3,5-trien-7-yl)methyl)methylamino)propyl)-1,3,4,5-tetrahydro-7,8-dimethoxy-, Monohydrochloride, (s)-

74. 3-[3-({[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino)propyl]-7,8-dimethoxy-2,3,4,5-tetrahydro-1h-3-benzazepin-2-one Hydrochloride

75. 3-[3-[[(8s)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1h-3-benzazepin-4-one Hydrochloride

76. 3-[3-[[(8s)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,5-trienyl]methyl-methylamino]propyl]-7,8-dimethoxy-2,5-dihydro-1h-3-benzazepin-4-one Hydrochloride3-[3-[[(8s)-3,4-dimethoxy-8-bicyclo[4.2.0]octa-1,3,

77. 3-{3-[{[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]-methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2h-3-benzazepin-2-one Hydrochloride

78. 3-{3-[{[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl}-7,8-dimethoxy-1,3,4,5-tetrahydro-2h-3-benzazepin-2-one--hydrogen Chloride (1/1)

79. N-{[(7s)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}-3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3h-3-benzazepin-3-yl)-n-methylpropan-1-aminium Chloride

2.4 Create Date

2005-08-09

3 Chemical and Physical Properties

Molecular Formula	C₂₇H₃₇ClN₂O₅
Molecular Weight	505.0 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	10
Exact Mass	504.2391000 g/mol
Monoisotopic Mass	504.2391000 g/mol
Topological Polar Surface Area	60.5 Å²
Heavy Atom Count	35
Formal Charge	0
Complexity	663
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Indication

Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated:

- in adults unable to tolerate or with a contra-indication to the use of beta-blockers

- in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

* Symptomatic treatment of chronic stable angina pectoris:

Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated:

- in adults unable to tolerate or with a contraindication to the use of beta-blockers

- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.

* Treatment of chronic heart failure:

Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Symptomatic treatment of chronic stable angina pectoris

Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated:

- in adults unable to tolerate or with a contraindication to the use of beta-blockers

- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.

Treatment of chronic heart failure

* Symptomatic treatment of chronic stable angina pectoris:

Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm.

Ivabradine is indicated:

- in adults unable to tolerate or with a contra-indication to the use of beta-blockers

- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.

* Treatment of chronic heart failure:

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate 70 bpm. Ivabradine is indicated: - in adults unable to tolerate or with a contra-indication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Treatment of angina pectoris, Treatment of chronic heart failure, Treatment of coronary artery disease

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Cardiovascular Agents

Agents that affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume. (See all compounds classified as Cardiovascular Agents.)

5.2 ATC Code

C01EB17

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CHANDIGARH,? 160002, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726425000,"product":"PHARMACEUTICAL RAW MATERIAL IVABRADINE HYDROCHLORIDE","address":"4, DIPALI SOCIETY,,KUNDAN, MAKTAMP","city":"BHARUCH,GUJARAT","supplier":"LEWENS LABS","supplierCountry":"INDIA","foreign_port":"HO CHI MINH C","customer":"TO THE ORDER OF","customerCountry":"VIETNAM","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"4500","totalValueFC":"8833.6","currency":"USD","unitRateINR":370135,"date":"16-Sep-2024","totalValueINR":"740270","totalValueInUsd":"8833.6","indian_port":"Bombay Air","hs_no":"29337990","bill_no":"4042668","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"4, DIPALI SOCIETY,,KUNDAN, MAKTAMP, BHARUCH,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726770600,"product":"IVABRADINE HCL IH (THIRD PARTY INVOICE NO. MH4824270014 DATE. 31.08.2024)","address":"FLAT NO.301 PLOT NO A 68,SECTOR 10","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"ASTER INTERNATIONAL PHARMACEUTICALS LLP","supplierCountry":"INDIA","foreign_port":"BIRGUNJ","customer":"NEPAL PHARMACEUTICALS LAB ","customerCountry":"NEPAL","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"400000","totalValueFC":"23866","currency":"INR","unitRateINR":399999.98999999999,"date":"20-Sep-2024","totalValueINR":"1999999.95","totalValueInUsd":"23866","indian_port":"Raxaul","hs_no":"29420090","bill_no":"4199878","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Raxaul","supplierAddress":"FLAT NO.301 PLOT NO A 68,SECTOR 10, NAVI MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"IVABRADINE HYDROCHLORIDE","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON","supplierCountry":"INDIA","foreign_port":"LAHORE","customer":"SAFFRON PHARMACEUTICAL PVT ","customerCountry":"PAKISTAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4600","totalValueFC":"4210.2","currency":"USD","unitRateINR":352820,"date":"28-Sep-2024","totalValueINR":"352820","totalValueInUsd":"4210.2","indian_port":"Hyderabad Air","hs_no":"29331999","bill_no":"4422662","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C, BANGALORE,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728153000,"product":"IVABRADINE HYDROCHLORIDE","address":"55\/547, MHB COLONY, NEAR VASANT","city":"HALL, KANDIVALI (W), MUMBAI","supplier":"SUDARSHAN PHARMA INDUSTRIES ","supplierCountry":"INDIA","foreign_port":"KATHMANDU","customer":"DIVINE HEALTHCARE PVT. LTD.","customerCountry":"NEPAL","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"147000","totalValueFC":"1749.4","currency":"INR","unitRateINR":147000,"date":"06-Oct-2024","totalValueINR":"147000","totalValueInUsd":"1749.4","indian_port":"Raxaul","hs_no":"29420090","bill_no":"4623542","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Raxaul","supplierAddress":"55\/547, MHB COLONY, NEAR VASANT, HALL, KANDIVALI (W), MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728239400,"product":"IVABRADINE HYDROCHLORIDE","address":"55\/547, MHB COLONY, NEAR VASANT","city":"HALL, KANDIVALI (W), MUMBAI","supplier":"SUDARSHAN PHARMA INDUSTRIES ","supplierCountry":"INDIA","foreign_port":"KATHMANDU","customer":"DIVINE HEALTHCARE PVT. LTD.","customerCountry":"NEPAL","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"147000","totalValueFC":"1749.4","currency":"INR","unitRateINR":147000.01000000001,"date":"07-Oct-2024","totalValueINR":"147000.01","totalValueInUsd":"1749.4","indian_port":"Raxaul","hs_no":"29420090","bill_no":"4638839","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"NEPAL","selfForZScoreResived":"Pharma Grade","supplierPort":"Raxaul","supplierAddress":"55\/547, MHB COLONY, NEAR VASANT, HALL, KANDIVALI (W), MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728930600,"product":"PHARMACEUTICAL RAW MATERIAL IVABRADINE HYDROCHLORIDE","address":"301\/302, ASHFORD CHAMBERS, LADY","city":"MUMBAI, MAHARASHTRA","supplier":"KORES INDIA LIMITED","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"HABIB METROPOLITAN","customerCountry":"PAKISTAN","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"4650","totalValueFC":"4361.4","currency":"USD","unitRateINR":366471,"date":"15-Oct-2024","totalValueINR":"366471","totalValueInUsd":"4361.4","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"4824793","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"301\/302, ASHFORD CHAMBERS, LADY, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732559400,"product":"IVABRADINE HYDROCHLORIDE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ZYDUS LIFESCIENCES LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"GENEPHARM S.A","customerCountry":"GREECE","quantity":"14.99","actualQuantity":"14.994","unit":"KGS","unitRateFc":"6000","totalValueFC":"92134.9","currency":"EUR","unitRateINR":518547.12218220619,"date":"26-Nov-2024","totalValueINR":"7775095.55","totalValueInUsd":"92134.9","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"5905662","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670956200,"product":"CHEMICAL : IVABRADINE HCI (FORMA IV)","address":"TORRENT HOUSE,","city":"AHMEDABAD. GUJARAT","supplier":"URQUIMA S.A. GRUPO URIACH","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TORRENT PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"14445.9","totalValueFC":"158121.3","currency":"USD","unitRateINR":"1184562.5","date":"14-Dec-2022","totalValueINR":"13030188","totalValueInUsd":"158121.3","indian_port":"Dahez-SEZ","hs_no":"29337990","bill_no":"1005539","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL. IND. RIERA DE CALDES PALAU- SO LITA I PLEGAMANS 08184 BARCELONA SP AIN , SPAIN SPAIN","customerAddress":"TORRENT HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727289000,"product":"19701 - IVABRADINE HYDROCHLORIDE (QTY - 7.796 KGS)","address":"CENTAUR HOUSE, SHANTI NAGAR,","city":"MUMBAI ,MAHARASHTRA","supplier":"URQUIMA S.A. GRUPO URIACH","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"CENTAUR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"7.80","actualQuantity":"7.796","unit":"KGS","unitRateFc":"10500","totalValueFC":"92504.1","currency":"EUR","unitRateINR":"994350","date":"26-Sep-2024","totalValueINR":"7751952.6","totalValueInUsd":"92504.1","indian_port":"Bombay Air","hs_no":"29337990","bill_no":"5805291","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL,IND.RIERA DE CALDES PALAU-SOLIT A I PIEGAMANS 08184 BARCELONA Barce lona, , Spain Spain","customerAddress":"CENTAUR HOUSE, SHANTI NAGAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"IVABRADINE HYDROCHLORIDE","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"ZHEJIANG LIAOYUAN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"1.10","actualQuantity":"1.1","unit":"KGS","unitRateFc":"7000","totalValueFC":"7751.3","currency":"USD","unitRateINR":"594650","date":"07-Nov-2024","totalValueINR":"654115","totalValueInUsd":"7751.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6538541","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":".,LTD. ZHEJIANG PROVINCIAL CHEMICAL AND MEDICAL RAW MATERIAL BASE , LINHAI ZONE, DUQIO TOWN,LINHAI CITY CHINA","customerAddress":"304,ATLANTA ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732300200,"product":"IVABRADINE HYDROCHLORIDE","address":"CENTAUR HOUSE, SHANTI NAGAR,","city":"MUMBAI ,MAHARASHTRA","supplier":"URQUIMA S.A. GRUPO URIACH","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"CENTAUR PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"10500","totalValueFC":"112977.9","currency":"EUR","unitRateINR":"953400","date":"23-Nov-2024","totalValueINR":"9534000","totalValueInUsd":"112977.9","indian_port":"Bombay Air","hs_no":"29337990","bill_no":"6836888","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"POL,IND.RIERA DE CALDES PALAU-SOLIT A I PIEGAMANS 08184 BARCELONA Barce lona, , Spain Spain","customerAddress":"CENTAUR HOUSE, SHANTI NAGAR,"}]

Number of Transactions

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Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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01

DKSH

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Grade : Oral

Category : Coating Systems & Additives, Coloring Agents

Brand Name : Titanium dioxide PRETIOX AV01FG

Application : Coating Systems & Additives, Coloring Agents

Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.

Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...

Technical Specs : Ti 59.95% and O 40.05%

Ingredient(s) : Titanium Dioxide

02

DKSH

Switzerland

Pharma, Lab & Chemical Expo

Not Confirmed

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Coating Systems & Additives, Coloring Agents

Brand Name : Titanium dioxide PRETIOX AV01PhG

Application : Coating Systems & Additives, Coloring Agents

Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.

Pharmacopoeia Ref : N/A

Technical Specs : Ti 59.95% and O 40.05%

Ingredient(s) : Titanium Dioxide

03

Seppic

France

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04

Seppic

France

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ABOUT THIS PAGE

Ivabradine Hydrochloride Manufacturers

A Ivabradine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivabradine Hydrochloride, including repackagers and relabelers. The FDA regulates Ivabradine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivabradine Hydrochloride 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 Ivabradine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ivabradine Hydrochloride Suppliers

A Ivabradine Hydrochloride supplier is an individual or a company that provides Ivabradine Hydrochloride active pharmaceutical ingredient (API) or Ivabradine Hydrochloride finished formulations upon request. The Ivabradine Hydrochloride suppliers may include Ivabradine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Ivabradine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ivabradine Hydrochloride USDMF

A Ivabradine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivabradine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ivabradine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ivabradine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ivabradine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ivabradine Hydrochloride USDMF includes data on Ivabradine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivabradine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ivabradine Hydrochloride suppliers with USDMF on PharmaCompass.

Ivabradine Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Ivabradine Hydrochloride Drug Master File in Japan (Ivabradine Hydrochloride JDMF) empowers Ivabradine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Ivabradine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ivabradine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Ivabradine Hydrochloride suppliers with JDMF on PharmaCompass.

Ivabradine Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Ivabradine Hydrochloride Drug Master File in Korea (Ivabradine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ivabradine Hydrochloride. The MFDS reviews the Ivabradine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ivabradine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Ivabradine Hydrochloride 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 Ivabradine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Ivabradine Hydrochloride suppliers with KDMF on PharmaCompass.

Ivabradine Hydrochloride WC

A Ivabradine Hydrochloride written confirmation (Ivabradine Hydrochloride WC) is an official document issued by a regulatory agency to a Ivabradine Hydrochloride manufacturer, verifying that the manufacturing facility of a Ivabradine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ivabradine Hydrochloride APIs or Ivabradine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ivabradine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Ivabradine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Ivabradine Hydrochloride NDC

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 Ivabradine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ivabradine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Ivabradine Hydrochloride 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Ivabradine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ivabradine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ivabradine Hydrochloride suppliers with NDC on PharmaCompass.

Ivabradine Hydrochloride GMP

Ivabradine Hydrochloride 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 Ivabradine Hydrochloride 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 Ivabradine Hydrochloride GMP manufacturer or Ivabradine Hydrochloride GMP API supplier for your needs.

Ivabradine Hydrochloride CoA

A Ivabradine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ivabradine Hydrochloride's compliance with Ivabradine Hydrochloride specifications and serves as a tool for batch-level quality control.

Ivabradine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ivabradine Hydrochloride 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.

Ivabradine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ivabradine Hydrochloride EP), Ivabradine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ivabradine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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