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ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 10 USDMF, 4 EU WC, 4 NDC API, 10 Listed Suppliers, $ API Reference Price

15 API Suppliers
10 USDMF
4 EU WC
4 NDC API
10 Listed Suppliers
$ API Reference Price

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

42 FDF Dossiers, 25 FDA Orange Book, 9 Europe, 2 Canada, 1 South Africa, 5 Listed Dossiers

42 FDF Dossiers
25 FDA Orange Book
9 Europe
2 Canada
1 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 10MG/ML, INJECTABLE;INJECTION - 1GM/100ML, INJECTABLE;INJECTION - 2GM/100ML

drugProductComposition
INJECTABLE;INJECTION - 10MG/ML
INJECTABLE;INJECTION - 1GM/100ML
INJECTABLE;INJECTION - 2GM/100ML

RELATED EXCIPIENT COMPANIES

3 Actylis

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3 Actylis

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Finished Drug Prices

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4 Finished Drug Prices

MARKET PLACE

8 APIs, 2 FDF Dossiers

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8 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 7 Health Canada Patents

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4 US Patents
7 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP , 3 Others

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1 USP
3 Others

Zhejiang Esmolol Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

15

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10

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0

CEP/COS

CEP/COS Certifications

0

JDMF

4

EU WC

0

KDMF

4

NDC API

0

VMF

10

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 2,930

MARKET PLACE

8

API

2

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

42

FDF Dossiers

25

FDA Orange Book

FDA (Orange Book)

9

Europe

2

Canada

0

Australia

1

South Africa

5

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

1

USP

0

JP

3

Others

PATENTS & EXCLUSIVITIES

4

US Patents

0

US Exclusivities

7

Health Canada Patents

DIGITAL CONTENT

1

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13

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Chemistry

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Also known as: 81161-17-3, Esmolol hcl, Brevibloc, Esmolol (hydrochloride), Asl-8052, Esmolol hydrochloride [usan]

Molecular Formula

C₁₆H₂₆ClNO₄

Molecular Weight

331.8 g/mol

InChI Key

GEKNCWBANDDJJL-UHFFFAOYSA-N

FDA UNII

V05260LC8D

Esmolol Hydrochloride

Esmolol Hydrochloride is the hydrochloride salt form of esmolol, a short and rapid-acting beta adrenergic antagonist belonging to the class II anti-arrhythmic drugs and devoid of intrinsic sympathomimetic activity. Esmolol hydrochloride competitively blocks beta-1 adrenergic receptors in cardiac muscle and reduces the contractility and cardiac rate of heart muscle, thereby decreasing cardiac output and myocardial oxygen demands. This agent also decreases sympathetic output centrally and blocks renin secretion. At higher doses, esmolol hydrochloride also blocks beta-2 receptors located in bronchial and vascular smooth muscle, thereby leading to smooth muscle relaxation.

1 2D Structure

Esmolol Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

methyl 3-[4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]propanoate;hydrochloride

2.1.2 InChI

InChI=1S/C16H25NO4.ClH/c1-12(2)17-10-14(18)11-21-15-7-4-13(5-8-15)6-9-16(19)20-3;/h4-5,7-8,12,14,17-18H,6,9-11H2,1-3H3;1H

2.1.3 InChI Key

GEKNCWBANDDJJL-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(C)NCC(COC1=CC=C(C=C1)CCC(=O)OC)O.Cl

2.2 Other Identifiers

2.2.1 UNII

V05260LC8D

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Asl 8052

2. Asl-8052

3. Brevibloc

4. Esmolol

2.3.2 Depositor-Supplied Synonyms

1. 81161-17-3

2. Esmolol Hcl

3. Brevibloc

4. Esmolol (hydrochloride)

5. Asl-8052

6. Esmolol Hydrochloride [usan]

7. Methyl 3-[4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl]propanoate;hydrochloride

8. Asl8052

9. V05260lc8d

10. Dsstox_cid_28929

11. Dsstox_rid_83195

12. Dsstox_gsid_49003

13. Benzenepropanoic Acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, Methyl Ester, Hydrochloride

14. Asl 8052

15. (+-)-methyl P-(2-hydroxy-3-(isopropylamino)propoxy)hydrocinnamate Hydrochloride

16. 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)benzenepropanoic Acid Methyl Ester Hcl

17. Chebi:4857

18. Cas-81161-17-3

19. Hsdb 6530

20. Ncgc00185766-01

21. Brevibloc In Plastic Container

22. Unii-v05260lc8d

23. Sr-01000763706

24. Methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)propanoate Hydrochloride

25. Methyl 3-{4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl}propanoate Hydrochloride

26. Brevibloc (tn)

27. Clol

28. Brevibloc Double Strength In Plastic Container

29. Schembl41086

30. Esmolol Hydrochloride- Bio-x

31. Mls001401393

32. Chembl1201115

33. Dtxsid7049003

34. Esmolol Hydrochloride (jan/usp)

35. Esmolol Hydrochloride [mi]

36. Esmolol Hydrochloride [jan]

37. Bcp28434

38. Hy-b1392

39. Esmolol Hydrochloride [hsdb]

40. Tox21_113496

41. Esmolol Hydrochloride [vandf]

42. Mfcd00941432

43. S4100

44. Esmolol Hydrochloride [mart.]

45. Akos015895316

46. Esmolol Hydrochloride [usp-rs]

47. Esmolol Hydrochloride [who-dd]

48. Tox21_113496_1

49. Ab07716

50. Ac-6972

51. Ccg-100972

52. Ccg-220890

53. Cs-4908

54. Ks-1353

55. Nc00222

56. Ncgc00185766-04

57. Be164425

58. Benzenepropanoic Acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, Methyl Ester, Hydrochloride, (+-)-

59. Smr000469141

60. Esmolol Hydrochloride [orange Book]

61. Esmolol Hydrochloride [usp Monograph]

62. Ft-0601541

63. Ft-0667970

64. Ft-0667971

65. Sw197602-3

66. D00644

67. Esmolol Hydrochloride, >=98% (hplc), Solid

68. F20655

69. 1-(3-methylphenyl)piperazinedihydrochloridehydrate

70. 598e034

71. 81161-17-3, 81147-92-4(free Base)

72. J-003862

73. Q-201070

74. Sr-01000763706-4

75. Q27106523

76. Esmolol Hcl; Brevibloc; Asl-8052; Asl 8052; Asl 805

77. Esmolol Hydrochloride, United States Pharmacopeia (usp) Reference Standard

78. (+/-)-methyl P-(2-hydroxy-3-(isopropylamino)propoxy)hydrocinnamate Hydrochloride

79. (+/-)-methyl P-[2-hydroxy-3-(isopropylamino) Propoxy]hydrocinnamate Hydrochloride

80. Methyl 3-{4-[2-hydroxy-3-(isopropylamino)propoxy]-phenyl}propanoate Hydrochloride

81. Benzenepropanoic Acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, Methyl Ester, Hydrochloride (1:1)

82. Benzenepropanoic Acid, 4-(2-hydroxy-3-((1-methylethyl)amino)propoxy)-, Methyl Ester, Hydrochloride, (+/-)-

83. Methyl 3-{4-[2-hydroxy-3-(isopropylamino)propoxy]phenyl}propanoate Hydrochloride (esmolol Hcl)

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₂₆ClNO₄
Molecular Weight	331.8 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	10
Exact Mass	331.1550360 g/mol
Monoisotopic Mass	331.1550360 g/mol
Topological Polar Surface Area	67.8 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	288
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Brevibloc
PubMed Health	Esmolol (Injection)
Drug Classes	Antiarrhythmic, Group II, Cardiovascular Agent
Drug Label	BREVIBLOC (Esmolol Hydrochloride) is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol hydrochloride is:()-Methyl p-[2-hydroxy-3-(isopropylamino) propoxy] hydrocinnam...
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	10mg/ml
Market Status	Prescription
Company	Baxter Hlthcare

2 of 8
Drug Name	Brevibloc double strength in plastic container
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	2gm/100ml
Market Status	Prescription
Company	Baxter Hlthcare

3 of 8
Drug Name	Brevibloc in plastic container
Drug Label	Esmolol hydrochloride is a beta1-selective (cardioselective) adrenergic receptor blocking agent with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol hydrochloride is:()-Methyl p-[2-hydroxy-3-(isopropylami...
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	1gm/100ml
Market Status	Prescription
Company	Baxter Hlthcare

4 of 8
Drug Name	Esmolol hydrochloride
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	2000mg/100ml (20mg/ml); 2500mg/250ml (10mg/ml); 10mg/ml
Market Status	Tentative Approval; Prescription
Company	Fresenius Kabi Usa; Hq Speciality Pharma; Mylan Institutional; Eurohlth Intl

5 of 8
Drug Name	Brevibloc
PubMed Health	Esmolol (Injection)
Drug Classes	Antiarrhythmic, Group II, Cardiovascular Agent
Drug Label	BREVIBLOC (Esmolol Hydrochloride) is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol hydrochloride is:()-Methyl p-[2-hydroxy-3-(isopropylamino) propoxy] hydrocinnam...
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	10mg/ml
Market Status	Prescription
Company	Baxter Hlthcare

6 of 8
Drug Name	Brevibloc double strength in plastic container
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	2gm/100ml
Market Status	Prescription
Company	Baxter Hlthcare

7 of 8
Drug Name	Brevibloc in plastic container
Drug Label	Esmolol hydrochloride is a beta1-selective (cardioselective) adrenergic receptor blocking agent with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol hydrochloride is:()-Methyl p-[2-hydroxy-3-(isopropylami...
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	1gm/100ml
Market Status	Prescription
Company	Baxter Hlthcare

8 of 8
Drug Name	Esmolol hydrochloride
Active Ingredient	Esmolol hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	2000mg/100ml (20mg/ml); 2500mg/250ml (10mg/ml); 10mg/ml
Market Status	Tentative Approval; Prescription
Company	Fresenius Kabi Usa; Hq Speciality Pharma; Mylan Institutional; Eurohlth Intl

4.2 Therapeutic Uses

Adrenergic Beta-Antagonists

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

Esmolol is used IV principally to provide rapid, temporary control of ventricular rate in patients with supraventricular tachyarrhythmias (SVT) (eg, atrial flutter and/or fibrillation, sinus tachycardia).

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1748

Esmolol may be preferred to longer-acting B-adrenergic blocking agents for the short-term control of ventricular rate in patients with SVT because of the drug's rapid onset and short duration of effects, ... .

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1748

Esmolol is indicated for rapid and short-term control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergency situations. It is also indicated in noncompensatory sinus tachycardia judged by the physician to need intervention. (Esmolol is used for control of heart rate in patients with myocardial ischemia. /NOT included in US product labeling/) It is not recommended for use in chronic situations where transfer to another agent is anticipated. /Included in US product labeling/

MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1231

For more Therapeutic Uses (Complete) data for ESMOLOL HYDROCHLORIDE (6 total), please visit the HSDB record page.

4.3 Drug Warning

Because of the risk of esmolol induced hypotension, blood pressure should be monitored closely during therapy with this drug, especially in patients with low pretreatment blood pressure (eg, systolic blood pressure less than 105 mm Hg). Hypotension can occur at any dose level with esmolol but usually is dose related, and doses exceeding 200 ug/kg per minute recommended by the manufacturer for the management of supraventricular tachyarrhythmias. Reversal of hypotension usually occurs within 30 minutes of discontinuing the drug or reducing the rate of IV infusion.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1751

... Esmolol is contraindicated in patients with second- or third-degree atrioventricular blocks, sinus bradycardia, cardiogenic shock, or overt cardiac failure.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1751

Esmolol may mask signs and symptoms of hypoglycemia (eg, tachycardia, palpitation, blood pressure changes, tremor, feelings of anxiety, but not sweating or dizziness) and may potentiate insulin-induced hypoglycemia; therefore, the drug should be used with caution in patients with diabetes mellitus or hypoglycemia.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1751

Because of de-esterified metabolite (ASL 8123) of esmolol is eliminated mainly by the kidneys, ... the drug should be used with caution in patients with renal impairment, especially severe impairment.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1751

For more Drug Warnings (Complete) data for ESMOLOL HYDROCHLORIDE (16 total), please visit the HSDB record page.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Adrenergic beta-1 Receptor Antagonists

Drugs that bind to and block the activation of ADRENERGIC BETA-1 RECEPTORS. (See all compounds classified as Adrenergic beta-1 Receptor Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

beta-Adrenergic Blocker [EPC]; Adrenergic beta-Antagonists [MoA]

5.3 Absorption, Distribution and Excretion

It is not known whether esmolol and/or ASL 8123 cross the placenta in humans, but the drug has been shown to cross the placenta in animals. In animals, fetal artery esmolol concentrations were about 10% of maternal concentrations at the completion of infusion. It also is not known whether esmolol and/or ASL 8123 are distributed into milk.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1753

Following IV administration, esmolol is rapidly and widely distributed. The apparent volumes of distribution of esmolol and its de-esterifed metabolite (ASL 8123) in healthy adults are approximately 3.4 and 0.41 l/kg, respectively, following iv administration. In healthy adults, the volumes of distribution of esmolol in the central compartment and at steady state are approximately 0.87 and 1.2 l/kg, respectively, following IV administration. The apparent volume of distribution appears to be decreased in patients undergoing coronary artery bypass surgery and increased in patients with renal impairment undergoing peritoneal dialysis and in patients with liver cirrhosis.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1753

Following IV administration in rats, esmolol is ditributed into liver and kidneys, but only minimally into CSF, spleen, or testes.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1753

In vitro, esmolol is approximately 55% bound to plasma proteins, mainly albumin and alpha-1-acid glycoprotein. Protein binding of esmolol to alpha-1-acid glycoprotein does not appear to be concentration dependent at esmolol concentrations of 3-110 ug/ml. In vitro, ASL 8123 is approximately 10% bound to plasma proteins.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1753

For more Absorption, Distribution and Excretion (Complete) data for ESMOLOL HYDROCHLORIDE (10 total), please visit the HSDB record page.

5.4 Metabolism/Metabolites

Esmolol is rapidly and extensively metabolized via esterases (probably arylesterase), principally in the cytosol of erythrocytes. Metabolism of the drug also may occur in highly perfused tissues that contain esterases (eg, liver, kidneys). Hydrolysis of the methyl ester moiety results in formation of the de-esterified (free acid) metabolite, 4-(2-hydroxy-3-((1-methylethyl)amino) propoxy)benzenepropanoic acid (ASL 8123), and methanol. Esmolol does not appear to be susceptible to hydrolysis via serum cholinesterase (pseudocholinesterase), acetylcholinesterase, or carbonic anhydrase. It is estimated that about 83% of an esmolol dose is metabolized to ASL 8123. ASL 8123 has a low affinity for beta-adrenergic receptors, exhibiting only minimal (about 1,000- to 1,500-fold less potent than esmolol) beta-blocking activity in animals and no appreciable blockade in humans. Unlike esmolol, ASL 8123 is eliminated principally by the kidneys, and the elimination half-life of the metabolite may be increased up to tenfold in patients with renal impairment; however, such accumulation is not thought to be clinically important since ASL 8123 has only minimal beta-blocking activity. The amount of methanol formed during hydrolysis of the drug does not appear to be clinically important. Following IV infusion of esmolol hydrochloride doses of 300 ug/kg per minute for up to l6 hours of 150 ug/kg per minute for 24 hours, blood methanol concentrations ranged from 2.8-5.9 or 2.9-13.2 ug/ml, respectively, being less than 2% of those usually associated with methanol toxicity.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1753

5.5 Biological Half-Life

Following IV infusion in adults, the half life of esmolol averages about 2 minutes in the initial distribution phase and about 9 minutes (range: 5-23 minutes) in the terminal elimination phase, although considerable interindividual variation in blood elimination half life exists.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1753

Free acid metabolite: approx 3.7 hr (increased up to tenfold in renal failure)

MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1231

5.6 Mechanism of Action

Esmolol selectively inhibits response to adrenergic stimuli by competitively blocking cardiac B1-adrenergic receptors, while having little effect on the B2-adrenergic receptors of bronchial and vascular smooth muscle. At high doses (e.g., greater than 300 ug/kg per minute), this selectivity of esmolol for B1-adrenergic receptors usually diminishes, and the drug will competitively inhibit B1-and B2-adrenergic receptors.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1752

By inhibiting myocardial beta1-adrenergic receptors, esmolol produces negative chronotropic and inotropic activity. Through its myocardial B1-adrenergic blocking action, esmolol decreases resting and exercise-induced heart rate, reflex orthostatic tachycardia, myocardial contractility, rate of left ventricular pressure rise (dp/dt), right ventricular contractility, and cardiac index.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1752

The decrease in myocardial contractility, arterial pressure, and heart rate produced by esmolol can lead to a reduction in myocardial oxygen consumption, which may account for the effectiveness of the drug in myocardial ischemia.

McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 1753

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Esmolol Hydrochloride IH

Date of Issue : 2022-07-15

Valid Till : 2025-05-28

Written Confirmation Number : WC-0019A3

Address of the Firm : Plot No. 115, Ramky Pharma City India Ltd. SEZ, Parwada Mandai, Visakhapatnam Di...

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02

Global Calcium

India

Pharma, Lab & Chemical Expo

Not Confirmed

03

Mehta API

India

Pharma, Lab & Chemical Expo

Not Confirmed

04

MSN Laboratories

India

Pharma, Lab & Chemical Expo

Not Confirmed

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NDC API

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Listed Suppliers

01

Zhejiang Hengkang Pharmaceutical

China

Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

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China

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Esmolol Hydrochloride

About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...

Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming to global API standards, along with professional R&D and marketing teams, Hengkang’s operations span major pharmaceutical markets such as China, Europe, the CIS region, Japan, and South Korea. Hengkang has established long-term and stable relationships with nearly 70 countries overseas and hundreds of domestic enterprises.

Zhejiang Hengkang Pharmaceutical

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02

ChemWerth Inc

U.S.A

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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U.S.A

Digital Content

Esmolol Hydrochloride

About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.

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03

Minakem

France

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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France

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Esmolol Hydrochloride

About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...

MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported by strong analytical and regulatory affairs services. The R&D team has an expertise in process development, organic synthesis, and works under a secrecy agreement to protect your IP. With 3 production sites in Europe and 1 in Canada, Minakem is ready to support your strategic sourcing projects or your reshoring activities. Recently launched commercial generic API: Apixaban, Mirabegron, Fulvestrant, remifentanil, esmolol,

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Digital Content

04

Axplora

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

Axplora- The partner of choice for complex APIs.

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Germany

Digital Content

Esmolol Hydrochloride

About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.

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05

Minakem (formerly Delmar Chemicals)

Canada

Pharma, Lab & Chemical Expo

Not Confirmed

Minakem is manufacturing small molecules APIs including corticosteroids

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Canada

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Esmolol Hydrochloride

About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...

Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our employees operate a regularly inspected cGMP facility equipped with reactors ranging from 40 to 7,600 litres. Located in Montreal, Canada, we have contributed to the success of our North-American and international clients since 1964.

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Corporate PDF

06

Global Calcium

India

Pharma, Lab & Chemical Expo

Not Confirmed

07

Guangzhou Tosun Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

08

Mehta API

India

Pharma, Lab & Chemical Expo

Not Confirmed

09

Sailong Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

10

Tecoland Corporation

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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API Reference Price

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SPIPA, SATELLITE ROAD"},{"dataSource":"API Import","activeIngredients":"ESMOLOL HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1622053800,"product":"HISY-ESMH-C011-N ESMOLOL HYDROCHLORIDE USP (QTY:51.310 KGS X3500 USD)","address":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"51.31","actualQuantity":"51.31","unit":"KGS","unitRateFc":"3500","totalValueFC":"181670.6","currency":"USD","unitRateINR":"259350","date":"27-May-2021","totalValueINR":"13307248.5","totalValueInUsd":"181670.6","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"4102574","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"PLOT NO.2, MAITRIVIHAR,BEHIND MAITRIVANAM, AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1631989800,"product":"ESMOLOL HYDROCHLORIDE","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N AGAR","city":"CHENNAI,TAMIL NADU","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"6.45","actualQuantity":"6450","unit":"GMS","unitRateFc":"3.5","totalValueFC":"22833.9","currency":"USD","unitRateINR":"260.4","date":"19-Sep-2021","totalValueINR":"1679580","totalValueInUsd":"22833.9","indian_port":"MADRAS AIR","hs_no":"29225090","bill_no":"5505391","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N AGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1637865000,"product":"HISY-ESMH-C011-N ESMOLOL HYDROCHLORIDE USP","address":"PLOT NO.2, MAITHRIVIHAR AMEERPET,","city":"HYDERABAD","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"43.06","actualQuantity":"43.055","unit":"KGS","unitRateFc":"3500","totalValueFC":"151964.8","currency":"USD","unitRateINR":"262850","date":"26-Nov-2021","totalValueINR":"11317006.75","totalValueInUsd":"151964.8","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"6425576","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHAR AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1640802600,"product":"ESMOLOL HYDROCHLORIDE","address":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"18.95","actualQuantity":"18.95","unit":"KGS","unitRateFc":"3750","totalValueFC":"72686.6","currency":"USD","unitRateINR":"289312.5","date":"30-Dec-2021","totalValueINR":"5482471.88","totalValueInUsd":"72686.6","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"6898288","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670265000,"product":"ESMOLOL HYDROCHLORIDE USP","address":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta","city":"HYDERABAD","supplier":"F.I.S. FABBRICA ITALIANA SINTETICI","supplierCountry":"CANADA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"2400","totalValueFC":"1254.5","currency":"EUR","unitRateINR":"206760","date":"06-Dec-2022","totalValueINR":"103380","totalValueInUsd":"1254.5","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"3623844","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671993000,"product":"ESMOLOL HYDROCHLORIDE","address":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"101.04","actualQuantity":"101.04","unit":"KGS","unitRateFc":"3750","totalValueFC":"384158.8","currency":"USD","unitRateINR":"313312.5","date":"26-Dec-2022","totalValueINR":"31657095","totalValueInUsd":"384158.8","indian_port":"HYDERABAD AIR","hs_no":"29335990","bill_no":"3918085","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1672079400,"product":"HISY-ESMH-C011-N - ESMOLOL HYDROCHLORIDE - LOT#20221104,106,107,108","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"57.72","actualQuantity":"57.72","unit":"KGS","unitRateFc":"3275","totalValueFC":"191656.6","currency":"USD","unitRateINR":"273626.3","date":"27-Dec-2022","totalValueINR":"15793707.15","totalValueInUsd":"191656.6","indian_port":"BANGALORE AIR","hs_no":"29333990","bill_no":"3921283","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678041000,"product":"ESMOLOL HYDROCHLORIDE USP, HISY-ESMH-C011-N (40000 GMS)","address":"SURVEY NO.506, SACHANA KALYANPURA R TALUKA- KADI, PALLI, MEHSANA","city":"MEHSANA","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"AMNEAL INJECTABLES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"3225","totalValueFC":"130959.9","currency":"USD","unitRateINR":"269287.5","date":"06-Mar-2023","totalValueINR":"10771500","totalValueInUsd":"130959.9","indian_port":"AHMEDABAD AIR","hs_no":"29225014","bill_no":"4920523","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.506, SACHANA KALYANPURA R TALUKA- KADI, PALLI, MEHSANA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685125800,"product":"HISY ESMH C011 N ESMOLOL HYDROCHLORIDE QTY 103900 GMS X 3 20 USD GMS","address":"PLOT NO.2, MAITHRIVIHARAMEERPET","city":"HYDERABAD","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"103.90","actualQuantity":"103.9","unit":"KGS","unitRateFc":"3200","totalValueFC":"336584.4","currency":"USD","unitRateINR":"266560","date":"27-May-2023","totalValueINR":"27695584","totalValueInUsd":"336584.4","indian_port":"HYDERABAD AIR","hs_no":"29221990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"China","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHARAMEERPET"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690137000,"product":"HISY-ESMH-C011-N ESMOLOL HYDROCHLORIDE LOT# 20230606,607,609,610(QTY 59260 GRM)","address":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,","city":"HYDERABAD,TELANGANA","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"VIATRIS","customerCountry":"INDIA","quantity":"59.26","actualQuantity":"59.26","unit":"KGS","unitRateFc":"3275","totalValueFC":"195872.2","currency":"USD","unitRateINR":"271661.3","date":"24-Jul-2023","totalValueINR":"16098645.47","totalValueInUsd":"195872.2","indian_port":"BANGALORE AIR","hs_no":"29221990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"564\/A\/22, ROAD NO. 92,JUBILEE HILL S,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1690482600,"product":"FOC ESMOLOL HYDROCHLORIDE","address":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3","city":"","supplier":"BAXTER HEALTHCARE CORPORATION","supplierCountry":"FRANCE","foreign_port":"N\/A","customer":"SYNGENE INTERNATIONAL LIMITED","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"250","unit":"GMS","unitRateFc":"6","totalValueFC":"1513.9","currency":"USD","unitRateINR":"497.7","date":"28-Jul-2023","totalValueINR":"124425","totalValueInUsd":"1513.9","indian_port":"Biocon-SEZ","hs_no":"29225090","bill_no":"1010471","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"25212 W IL ROUTE 120 ROUND LAKE, IL 60073 UNITED STATES OF AMERICA","customerAddress":"BIOCON SEZ, BIOCON PARK,PLOT NO.2 3"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695839400,"product":"HISY-ESMH-C011-N ESMOLOL HYDROCHLORIDE USP LOT #20230810,811,813,814,815.(QTY 74040 GMS)","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"VIATRIS","customerCountry":"INDIA","quantity":"74.04","actualQuantity":"74.04","unit":"KGS","unitRateFc":"3175","totalValueFC":"238027.3","currency":"USD","unitRateINR":"266858.8","date":"28-Sep-2023","totalValueINR":"19758221.85","totalValueInUsd":"238027.3","indian_port":"Bangalore Air","hs_no":"29333990","bill_no":"8056740","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"1764 LITCHFIELD TURNPIKE SUITE 202WOODBRIDGE, CT, 06525SDNF United States","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702924200,"product":"ESMOLOL HYDROCHLORIDE USP","address":"NARBAVI, NO.3,LAKSHMANAN STREET,","city":"CHENNAI\/TAMILNADU","supplier":"CHEMWERTH INC","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CAPLIN POINT LABORATORIES 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","customerCountry":"INDIA","quantity":"102.35","actualQuantity":"102.35","unit":"KGS","unitRateFc":"3100","totalValueFC":"320959.7","currency":"USD","unitRateINR":"263035","date":"29-Aug-2024","totalValueINR":"26921632.25","totalValueInUsd":"320959.7","indian_port":"Hyderabad Air","hs_no":"29221990","bill_no":"5303623","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"1764 LITCHFIELD TURNPIKE SUITE 202WOODBRIDGE, CT, 06525 USA\/\/MFG-HUZHOU ZHANWANG PHARMACEUTICAL CO LTD-C United States","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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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INTERMEDIATES SUPPLIERS

01

Faran Shimi Pharmaceutical

Iran

Duphat

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Ethyl Chlorophormate

CAS Number : 79-22-1

End Use API : Esmolol Hydrochloride

Faran Shimi Pharmaceutical

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Europe

01

Baxter Medical AB

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

02

Baxter Medical AB

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

03

BAXTER SpA

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

04

BAXTER SpA

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

05

Baxter AS

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

06

Baxter AS

Germany

Pharma, Lab & Chemical Expo

Not Confirmed

07

Orpha-Devel Handels und

Country

Pharma, Lab & Chemical Expo

Not Confirmed

08

Orpha-Devel Handels und

Country

Pharma, Lab & Chemical Expo

Not Confirmed

09

Orpha-Devel Handels und

Country

Pharma, Lab & Chemical Expo

Not Confirmed

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Canada

01

BAXTER CORPORATION

U.S.A

Duphat

Not Confirmed

02

BAXTER CORPORATION

U.S.A

Duphat

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 10MG/ML

USFDA APPLICATION NUMBER - 19386

DOSAGE - INJECTABLE;INJECTION - 1GM/100ML

USFDA APPLICATION NUMBER - 19386

DOSAGE - INJECTABLE;INJECTION - 2GM/100ML

USFDA APPLICATION NUMBER - 19386

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ABOUT THIS PAGE

Esmolol Hydrochloride Manufacturers

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

Esmolol Hydrochloride Suppliers

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

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

Esmolol Hydrochloride USDMF

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

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

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

Esmolol Hydrochloride WC

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

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

Esmolol 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 Esmolol Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Esmolol 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 Esmolol 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 Esmolol Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Esmolol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

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

Esmolol Hydrochloride GMP

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

Esmolol Hydrochloride CoA

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

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

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