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Benzonatate

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CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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Synopsis

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Chemistry

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Also known as: 104-31-4, Benzononatine, Tessalon, Benzononantin, Exangit, Ventussin

Molecular Formula

C₃₀H₅₃NO₁₁

Molecular Weight

603.7 g/mol

InChI Key

MAFMQEKGGFWBAB-UHFFFAOYSA-N

Benzonatate is an oral antitussive drug used in the relief and suppression of cough in patients older than ten years of age. Currently, benzonatate is the only non-narcotic antitussive available as a prescription drug. It works to reduce the activity of cough reflex by desensitizing the tissues of the lungs and pleura involved in the cough reflex. Benzonatate was approved by the FDA in 1958 under the market name Tessalon Perles. Because its chemical structure resembles that of the anesthetic agents in the para-amino-benzoic acid class (such as [procaine] and [tetracaine]), benzonatate exhibits anesthetic or numbing action. Although it not prone to drug misuse or abuse, benzonatate is associated with a risk for severe toxicity and overdose, especially in children.

1 2D Structure

Benzonatate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[2-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethyl 4-(butylamino)benzoate

2.1.2 InChI

InChI=1S/C30H53NO11/c1-3-4-9-31-29-7-5-28(6-8-29)30(32)42-27-26-41-25-24-40-23-22-39-21-20-38-19-18-37-17-16-36-15-14-35-13-12-34-11-10-33-2/h5-8,31H,3-4,9-27H2,1-2H3

2.1.3 InChI Key

MAFMQEKGGFWBAB-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCCCNC1=CC=C(C=C1)C(=O)OCCOCCOCCOCCOCCOCCOCCOCCOCCOC

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Tessalon

2.2.2 Depositor-Supplied Synonyms

1. 104-31-4

2. Benzononatine

3. Tessalon

4. Benzononantin

5. Exangit

6. Ventussin

7. Benzonatatum

8. Tessalon-ciba

9. Ventussin-loz

10. Benzonatato

11. Tessalin

12. Zonatuss

13. Benzonatatum [inn-latin]

14. Benzonatato [inn-spanish]

15. Km65

16. 2,5,8,11,14,17,20,23,26-nonaoxaoctacosan-28-yl P-(butylamino)benzoate

17. P-(n)-butylaminobenzoesaeure-(nonaaethylenglykol-monomethylaether)-ester

18. 2,5,8,11,14,17,20,23,26-nonaoxaoctacosan-28-yl 4-(butylamino)benzoate

19. Benzoic Acid, 4-(butylamino)-, 3,6,9,12,15,18,21,24,27-nonaoxaoctacos-1-yl Ester

20. Chebi:3032

21. Nonaethyleneglycol Monomethyl Ether P-n-butylaminobenzoate

22. Tesalon

23. 4-(butylamino)benzoic Acid 3,6,9,12,15,18,21,24,27-nonaoxaoctacos-1-yl Ester

24. Benzoic Acid, 4-(butylamino)-, 2,5,8,11,14,17,20,23,26-nonaoxaoctacos-28-yl Ester

25. Nsc-760128

26. 2-[2-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethyl 4-butylaminobenzoate

27. Benzoic Acid, P-(butylamino)-, 2-(2-(2-(2-(2-(2-(2-(2-(2-methoxyethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethoxy)ethyl Ester

28. Ncgc00016362-01

29. Cas-104-31-4

30. P-butylaminobenzoic Acid Omega-o-methylnonaethyleneglycol Ester

31. 3,6,9,12,15,18,21,24,27-nonaoxaoctacosyl 4-butylaminobenzoate

32. Dsstox_cid_2655

33. Dsstox_rid_76676

34. Dsstox_gsid_22655

35. 3,6,9,12,15,18,21,24,27-nonaoxaoctacosyl-4-butylaminobenzoate;3,6,9,12,15,18,21,24,27-nonaoxaoctacosyl-4-butylaminobenzoate

36. Tessalon Perles (tn)

37. Benzonatate (usp/inn)

38. Einecs 203-194-7

39. Polyethyleneglycol-p-n-butylaminobenzoate Methyl Ester

40. Benzonatate [usp:inn:ban]

41. Hsdb 7933

42. P-(n)-butylaminobenzoesaeure-(nonaaethylenglykol-monomethylaether)-ester [german]

43. Prestwick0_000012

44. Prestwick1_000012

45. Prestwick2_000012

46. Prestwick3_000012

47. Schembl28366

48. Bspbio_000043

49. 2-[2-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethyl 4-(butylamino)benzoate

50. Mls002154171

51. Spbio_001964

52. Bpbio1_000049

53. Gtpl7611

54. Chembl1374379

55. Dtxsid9022655

56. Hms1568c05

57. Hms2095c05

58. Hms2230m19

59. Hms3373i11

60. Hms3712c05

61. Km-65

62. Pharmakon1600-01503864

63. Hy-b1551

64. Zinc3830276

65. Tox21_110398

66. Nsc760128

67. 3,6,9,12,15,18,21,24,27-nonaoxaoctacos-1-yl 4-(butylamino)benzoate

68. Akos015891366

69. Tox21_110398_1

70. Ccg-213706

71. Db00868

72. Nsc 760128

73. Ncgc00016362-02

74. Ncgc00016362-03

75. Ncgc00016362-05

76. Smr001233469

77. Ab00513795

78. Cs-0013413

79. Ft-0622718

80. D00242

81. Ab00513795_06

82. Sr-01000841197

83. J-001145

84. Q2070778

85. Sr-01000841197-2

86. Nonaethyleneglycol-p-n-butylaminobenzoate Methyl Ester

87. 3,6,9,12,15,18,21,24,27-nonaoxaoctacos-1-yl 4-(butylamino)benzoate #

2.3 Create Date

2005-03-27

3 Chemical and Physical Properties

Molecular Formula	C₃₀H₅₃NO₁₁
Molecular Weight	603.7 g/mol
XLogP3	2.4
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	12
Rotatable Bond Count	33
Exact Mass	603.36186151 g/mol
Monoisotopic Mass	603.36186151 g/mol
Topological Polar Surface Area	121 Å²
Heavy Atom Count	42
Formal Charge	0
Complexity	565
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

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Benzonatate
PubMed Health	Benzonatate (By mouth)
Drug Classes	Antitussive
Drug Label	Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg of b...
Active Ingredient	Benzonatate
Dosage Form	Capsule
Route	Oral
Strength	200mg; 100mg; 150mg
Market Status	Prescription
Company	Thepharmanetwork; Orit Labs; Sun Pharm Inds; Zydus Pharms Usa; The Pharma Network; Banner Pharmacaps; Mikart

2 of 4
Drug Name	Tessalon
PubMed Health	Benzonatate (By mouth)
Drug Classes	Antitussive
Drug Label	TESSALON, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.Each TESSALON Perle contains:Benzonatate, USP 100 mgTESSALON Perles (capsules) also c...
Active Ingredient	Benzonatate
Dosage Form	Capsule
Route	Oral
Strength	200mg; 100mg
Market Status	Prescription
Company	Pfizer

3 of 4
Drug Name	Benzonatate
PubMed Health	Benzonatate (By mouth)
Drug Classes	Antitussive
Drug Label	Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.Each soft gelatin capsule, for oral administration, contains 100 mg or 200 mg of b...
Active Ingredient	Benzonatate
Dosage Form	Capsule
Route	Oral
Strength	200mg; 100mg; 150mg
Market Status	Prescription
Company	Thepharmanetwork; Orit Labs; Sun Pharm Inds; Zydus Pharms Usa; The Pharma Network; Banner Pharmacaps; Mikart

4 of 4
Drug Name	Tessalon
PubMed Health	Benzonatate (By mouth)
Drug Classes	Antitussive
Drug Label	TESSALON, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p-(butylamino) benzoate; with a molecular weight of 603.7.Each TESSALON Perle contains:Benzonatate, USP 100 mgTESSALON Perles (capsules) also c...
Active Ingredient	Benzonatate
Dosage Form	Capsule
Route	Oral
Strength	200mg; 100mg
Market Status	Prescription
Company	Pfizer

4.2 Therapeutic Uses

Antitussive Agents

National Library of Medicine's Medical Subject Headings online file (MeSH, 2011)

Tessalon is indicated for the symptomatic relief of cough. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for TESSALON (benzonatate) capsule (February 2011). Available from, as of July 7, 2011: https://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=benzonatate

4.3 Drug Warning

Accidental ingestion of Tessalon resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

For more Drug Warnings (Complete) data for Benzonatate (8 total), please visit the HSDB record page.

4.4 Drug Indication

Benzonatate is indicated for the symptomatic relief of cough.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Benzonatate suppresses cough associated with both acute and chronic respiratory conditions. Its works by desensitizing the pulmonary stretch receptors involved in the cough reflex. There are limited clinical trials of benzonatate; however, earlier studies demonstrated inhibition of experimentally-induced cough and subjectively-measured pathological cough by benzonatate. Benzonatate has no inhibitory effects on the respiratory center in recommended dosage. Its onset of action is within 15 to 20 minutes following administration and its duration of effect is about 3 to 8 hours.

5.2 MeSH Pharmacological Classification

Antitussive Agents

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

Non-narcotic Antitussive [EPC]; Decreased Tracheobronchial Stretch Receptor Activity [PE]

5.4 ATC Code

R - Respiratory system

R05 - Cough and cold preparations

R05D - Cough suppressants, excl. combinations with expectorants

R05DB - Other cough suppressants

R05DB01 - Benzonatate

5.5 Absorption, Distribution and Excretion

Absorption

Following oral administration, benzonatate enters the systemic circulation via gastrointestinal absorption. The Cmax of benzonatate following oral administration of 100 mg in healthy Chinese volunteers was 1063 460 ng/mL.

Route of Elimination

There is limited information on the route of elimination of benzonatate.

Volume of Distribution

There is limited information on the volume of distribution of benzonatate.

Clearance

There is limited information on the clearance of benzonatate.

5.6 Metabolism/Metabolites

Benzonatate is hydrolyzed to the major metabolite 4-(butylamino)benzoic acid (BABA) by plasma butyrylcholinesterase (BChE).

5.7 Biological Half-Life

The half life of benzonatate following oral administration of 100 mg in healthy Chinese volunteers was 1.01 0.41 h.

5.8 Mechanism of Action

Benzonatate is a local anesthetic drug that acts peripherally by anesthetizing and reducing the activity of vagal stretch receptors or nerve fibres located in the respiratory passages, lungs, and pleura. Once the stretch receptors are stimulated, they send impulses to the cough centre located in the medulla via an afferent pathway consisting of sensory nerve fibres or the vagus nerve. The efferent signal is then generated that sends impulses to the expiratory muscles to produce a cough. Anesthetizing these receptors by benzonatate results in the inhibition of the cough reflex activity and cough production. Benzonatate also inhibits the transmission of impulses of the cough reflex in the vagal nuclei of the medulla. There are several proposed mechanisms of benzonatate; it is also a potent voltage-gated sodium channel inhibitor.

Benzonatate apparently inhibits cough production by anesthetizing stretch receptors of vagal afferent fibers in the bronchi, alveoli, and pleura that mediate the cough reflex; the drug also suppresses transmission of the cough reflex at the level of the medulla where the afferent impulse is transmitted to the motor nerves. The relationship between local anesthetic action and peripheral action on sensory nerve endings is not clear.

American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

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LIMITED","customerCountry":"INDIA","quantity":"1221.76","actualQuantity":"1221.76","unit":"KGS","unitRateFc":"110","totalValueFC":"138261.3","currency":"USD","unitRateINR":"9396.8","date":"01-Mar-2024","totalValueINR":"11480634.37","totalValueInUsd":"138261.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"2374351","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"36 HOPING STREET, LOUCHU, TAOYUAN 33842 Taoyuan, , TaiwanSDNF Taiwan","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"BENZONATATE USP\/DRM 50KG","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"GRACE","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"1065.90","actualQuantity":"1065.9","unit":"KGS","unitRateFc":"105.8","totalValueFC":"119598.3","currency":"USD","unitRateINR":"9317","date":"28-Mar-2024","totalValueINR":"9930935.54","totalValueInUsd":"119598.3","indian_port":"Bangalore Air","hs_no":"29224990","bill_no":"2788698","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"7500 GRACE DRIVECOLUMBIA, MD 21044, UNITED STATES","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712514600,"product":"BENZONATATE USP","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"3664.26","actualQuantity":"3664.26","unit":"KGS","unitRateFc":"105","totalValueFC":"388629.9","currency":"USD","unitRateINR":"8856.8","date":"08-Apr-2024","totalValueINR":"32453434.76","totalValueInUsd":"388629.9","indian_port":"Madras Sea","hs_no":"29224990","bill_no":"2939943","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"36 HOPING STREET,LOUCHU, TAOYUAN 33842SDNF TAIWAN","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713551400,"product":"BENZONATATE USP","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"6054.64","actualQuantity":"6054.64","unit":"KGS","unitRateFc":"105","totalValueFC":"642533.2","currency":"USD","unitRateINR":"8862","date":"20-Apr-2024","totalValueINR":"53656219.68","totalValueInUsd":"642533.2","indian_port":"Madras Sea","hs_no":"29224990","bill_no":"3117496","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"36 HOPING STREET,LOUCHU, TAOYUAN 33842, TAIWAN","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716748200,"product":"BENZONATATE USP (FREE OF COST-REPLACEMENT MATERIAL AGAINST INVOICE NO 23001187 SO DT.30.06.2023) (RI-EXP\/005\/23-24 DT.21","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"1221.05","actualQuantity":"1221.05","unit":"KGS","unitRateFc":"110","totalValueFC":"135920.2","currency":"USD","unitRateINR":"9278.5","date":"27-May-2024","totalValueINR":"11329512.43","totalValueInUsd":"135920.2","indian_port":"JNPT","hs_no":"29420090","bill_no":"3680775","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"36 HOPING STREET, LOUCHU, TAOYUAN 33842 Taoyuan, , TaiwanSDNF Taiwan","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"BENZONATATE USP","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"2446.56","actualQuantity":"2446.56","unit":"KGS","unitRateFc":"105","totalValueFC":"259413.9","currency":"USD","unitRateINR":"8851.5","date":"26-Jun-2024","totalValueINR":"21655725.84","totalValueInUsd":"259413.9","indian_port":"Madras Sea","hs_no":"29224990","bill_no":"4201167","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"36 HOPING STREET,LOUCHU, TAOYUAN 33842, TAIWAN","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"100% EOU - PHARMACEUTICAL ACTIVE INGREDIENTS - BENZONATATE -BATCH NO: F105PE-24072,F105PE-24073 VALID JUN 2029","address":"FIRST FLOOR, SF NO 534 42AB FLAT NO 102 ,? PLOT NO 27 PONNU GREEN FARMS, Samy Apartments Ponnu Green Form Padur ,? CHENNAI , ?KANCHIPURAM ,? TAMIL NADU,? 603103","city":"","supplier":"CHEMISTRY & HEALTH FZ-LLC","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"ESJAY PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1431.57","actualQuantity":"1431.57","unit":"KGS","unitRateFc":"105","totalValueFC":"152055.8","currency":"USD","unitRateINR":"8909.3","date":"31-Aug-2024","totalValueINR":"12754215.02","totalValueInUsd":"152055.8","indian_port":"Madras Sea","hs_no":"29163190","bill_no":"5362409","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"P.O. BOX 452820DUBAI SCEIENCE PARKDUBAI DUBAI","customerAddress":"FIRST FLOOR, SF NO 534 42AB FLAT NO 102 ,? PLOT NO 27 PONNU GREEN FARMS, Samy Apartments Ponnu Green Form Padur ,? CHENNAI , ?KANCHIPURAM ,? TAMIL NADU,? 603103"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"BENZONATATE USP","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"4894.95","actualQuantity":"4894.95","unit":"KGS","unitRateFc":"105","totalValueFC":"518868.8","currency":"USD","unitRateINR":"8883","date":"27-Sep-2024","totalValueINR":"43481840.85","totalValueInUsd":"518868.8","indian_port":"Madras Sea","hs_no":"29224990","bill_no":"5838801","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"36 HOPING STREET, LOUCHU, TAOYUAN 33842 , TAIWAN","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"BENZONATATE USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"1226.78","actualQuantity":"1226.78","unit":"KGS","unitRateFc":"105","totalValueFC":"130280","currency":"USD","unitRateINR":"8961.8","date":"27-Nov-2024","totalValueINR":"10994095.67","totalValueInUsd":"130280","indian_port":"JNPT","hs_no":"29420090","bill_no":"6908545","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"36 HOPING STREET, LOUCHU, TAOYUAN 3 3842 Taoyuan, , Taiwan SDNF Taiwan","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"BENZONATATE USP","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"FORMOSA LABORATORIES","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"4904.72","actualQuantity":"4904.72","unit":"KGS","unitRateFc":"105","totalValueFC":"539861.8","currency":"USD","unitRateINR":"9288.6","date":"29-Nov-2024","totalValueINR":"45557959.8","totalValueInUsd":"539861.8","indian_port":"Bangalore Air","hs_no":"29224990","bill_no":"6964441","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"36 HOPING STREET, LOUCHU, TAOYUAN 33842 , TAIWAN","customerAddress":"206, DEVAVRATA,"}]

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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FDF Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 100MG

USFDA APPLICATION NUMBER - 11210

DOSAGE - CAPSULE;ORAL - 200MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 11210

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Fillers, Diluents & Binders

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Market Place

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APIs

Benzonatate API needed in India [ENA15884]

A company that deals in various pharmaceutical products is looking for suppliers of Benzonatate API for commercial purposes. The suppliers must support this enquiry with CoA.

22 Dec 2022

Benzonatate (MOQ) API needed in India [ENA15123]

A company that focuses on the manufacturing of tablets, capsules, dry syrups & ointments is looking for suppliers of Benzonatate (MOQ) API for development purpose.

24 Sep 2022

Benzonatate (50 kg) API needed in Vietnam [ENA14133]

A company that deals in various pharmaceutical products is looking for suppliers of Benzonatate (50 kg) API for commercial purpose. The suppliers must support this enquiry with CoA.

29 Jun 2022

Benzonatate (MOQ) API needed in India [ENA10437]

One of the upcoming high-tech soft gel pharmaceutical and nutraceutical company that deals in various medicines is looking for suppliers of Benzonatate (MOQ) API for commercial manufacturing purposes.

18 May 2021

Various APIs needed in Vietnam [ENA10298]

A company that deals in medicines, pharmaceutical raw materials and medical devices is looking for suppliers of Various APIs for commercial manufacturing purposes. The suppliers must support this enquiry with CoA, DMF and GMP. 1. Prulifloxacin (100 kg) API 2. Benzonatate (30 kg) API 3. Buspirone (5 kg) API 4. Tedizolid (50 kg) API 5. Minocyclin (30 kg) API 6. Brexpiprazole (1 kg) API 7. Citiolone (25 kg) API 8. Cyclobenzaprine (10 kg) API

27 Apr 2021

Enquiry//Benzonatate 100kg, Acetaminophen 200kg for U.S. ANDA filing [EN00336][EN00337]

A U.S. based emerging generic manufacturer is searching for reliable manufacturers who can support their ANDA filings. They need 100kg Benzonatate and 200kg Acetaminophen on priority basis for their pilot trials in New York.

24 Mar 2016

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ABOUT THIS PAGE

Benzonatate Manufacturers

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

Benzonatate Suppliers

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

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

Benzonatate USDMF

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

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

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

Benzonatate KDMF

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

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

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

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

Benzonatate WC

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

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

Benzonatate 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 Benzonatate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Benzonatate GMP

Benzonatate 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 Benzonatate 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 Benzonatate GMP manufacturer or Benzonatate GMP API supplier for your needs.

Benzonatate CoA

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

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

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

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

7 USDMF

1 EU WC

1 KDMF

1 NDC API

6 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

40 FDF Dossiers

34 FDA Orange Book

6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG

CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

24 Fillers, Diluents & Binders

16 Direct Compression

15 Thickeners and Stabilizers

14 Disintegrants & Superdisintegrants

13 Film Formers & Plasticizers

11 Coating Systems & Additives

9 Co-Processed Excipients

8 Empty Capsules

7 Granulation

7 Taste Masking

6 Parenteral

5 Controlled & Modified Release

5 Topical

4 Chewable & Orodispersible Aids

3 Emulsifying Agents

3 Lubricants & Glidants

3 Solubilizers

2 Coloring Agents

2 Rheology Modifiers

1 Soft Gelatin

1 API Stability Enhancers

DIGITAL CONTENT

7 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

4 Finished Drug Prices

MARKET PLACE

6 APIs

CAPSULE;ORAL - 200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons