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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 3 CEP/COS, 1 EU WC, 1 KDMF, 4 NDC API, 11 Listed Suppliers, $ API Reference Price

17 API Suppliers
7 USDMF
3 CEP/COS
1 EU WC
1 KDMF
4 NDC API
11 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

34 FDF Dossiers, 13 FDA Orange Book, 4 Europe, 8 Canada, 1 South Africa, 8 Listed Dossiers

34 FDF Dossiers
13 FDA Orange Book
4 Europe
8 Canada
1 South Africa
8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - 0.02675%;0.315%, SOLUTION/DROPS;OPHTHALMIC - 0.025%;0.3%

drugProductComposition
SOLUTION/DROPS;OPHTHALMIC - 0.02675%;0.315%
SOLUTION/DROPS;OPHTHALMIC - 0.025%;0.3%

RELATED EXCIPIENT COMPANIES

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Biophore Naphazoline Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

17

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7

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3

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11

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API REF. PRICE (USD/KG)

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$ 516

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34

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13

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4

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8

Canada

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1

South Africa

8

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Chemistry

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Also known as: 550-99-2, Naphazoline hcl, Albalon, Rhinantin, Vasocon, Opcon

Molecular Formula

C₁₄H₁₅ClN₂

Molecular Weight

246.73 g/mol

InChI Key

DJDFFEBSKJCGHC-UHFFFAOYSA-N

FDA UNII

MZ1131787D

Naphazoline Hydrochloride

An adrenergic vasoconstrictor agent used as a decongestant.

1 2D Structure

Naphazoline Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-(naphthalen-1-ylmethyl)-4,5-dihydro-1H-imidazole;hydrochloride

2.1.2 InChI

InChI=1S/C14H14N2.ClH/c1-2-7-13-11(4-1)5-3-6-12(13)10-14-15-8-9-16-14;/h1-7H,8-10H2,(H,15,16);1H

2.1.3 InChI Key

DJDFFEBSKJCGHC-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CN=C(N1)CC2=CC=CC3=CC=CC=C32.Cl

2.2 Other Identifiers

2.2.1 UNII

MZ1131787D

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Afazol Grin

2. Ak Con

3. Ak-con

4. Albalon

5. All Clear

6. Clear Eyes

7. Colirio Alfa

8. Hydrochloride, Naphazoline

9. Idril

10. Miraclar

11. Monohydrochloride, Naphazoline

12. Nafazair

13. Naphazoline

14. Naphazoline Monohydrochloride

15. Naphazoline Nitrate

16. Naphcon

17. Naphcon Forte

18. Nitrate, Naphazoline

19. Optazine

20. Pensa, Vasoconstrictor

21. Privin

22. Privine

23. Proculin

24. Siozwo

25. Tele Stulln

26. Tele-stulln

27. Vasoclear

28. Vasocon

29. Vasocon Regular

30. Vasoconstrictor Pensa

31. Vasonit

2.3.2 Depositor-Supplied Synonyms

1. 550-99-2

2. Naphazoline Hcl

3. Albalon

4. Rhinantin

5. Vasocon

6. Opcon

7. Albalon Liquifilm

8. Rhinoperd

9. Stricylon

10. Naphcon

11. Niazol

12. Rinofug

13. Naphcon Forte

14. 2-(1-naphthylmethyl)-2-imidazoline Hydrochloride

15. Clera Hydrochloride

16. Naphazoline Chloride

17. Privine Hydrochloride

18. Prizole Hydrochloride

19. Nafazair

20. Sanorin

21. 2-(1-naphthylmethyl)imidazoline Hydrochloride

22. Naphazoline (hydrochloride)

23. Nsc-35711

24. 2-(naphthalen-1-ylmethyl)-4,5-dihydro-1h-imidazole Hydrochloride

25. 2-(1-naphthylmethyl)-2-imidazoline Monohydrochloride

26. 1h-imidazole, 4,5-dihydro-2-(1-naphthalenylmethyl)-, Monohydrochloride

27. Mls000028434

28. Chebi:7470

29. Naphazoline Hydrochloride (naphcon)

30. Mz1131787d

31. Smr000058292

32. Vasoclear

33. Coldan

34. 2-(naphthalen-1-ylmethyl)-4,5-dihydro-1h-imidazole;hydrochloride

35. Comfort Eye Drops

36. Degest-2

37. Naphazoliniumchlorid

38. Naphazolini Chloridum

39. Naphthasolium Chloride

40. Chembl1706

41. Clear Eyes

42. Naphazoline Hydrochloride [jan]

43. Hsdb 2174

44. Naphthylmethylimidazolinhydrochlorid

45. Einecs 208-989-2

46. Mfcd00012554

47. Nsc 35711

48. Albacon

49. 2-(1-naphthylmethyl)-4,5-dihydro-1h-imidazole

50. Sr-01000000067

51. Unii-mz1131787d

52. Prestwick_507

53. Albalon (tn)

54. Vasocon (tn)

55. Component Of Nasocon

56. Naphazoline Hydrochloride [usp:jan]

57. 2-imidazoline, 2-(1-naphthylmethyl)-, Monohydrochloride

58. Opera_id_230

59. Ac1lcwb1

60. Surecn1649580

61. Schembl24153

62. Mls001148448

63. Mls002222217

64. Naphazolinehydrochloride

65. Naphazoline Hydrochloride,(s)

66. Spectrum1500424

67. 2-(1-naphthylmethyl)-2-imidazoline Hydro- Chloride

68. Naphazoline Hcl [inci]

69. 2-imidazoline, Monohydrochloride

70. Dtxsid7045788

71. Molport-000-703-064

72. Hms1568i13

73. Hms1920p11

74. Pharmakon1600-01500424

75. Amy23173

76. Ex-a4103

77. Hy-b0446

78. Nsc35711

79. Ccg-40122

80. Nsc757110

81. S2519

82. Naphazoline Hydrochloride [mi]

83. Akos015908797

84. Naphazoline Hydrochloride (jp17/usp)

85. Nc00523

86. Nsc-757110

87. Naphazoline Hydrochloride [hsdb]

88. Naphazoline Hydrochloride [mart.]

89. Naphazoline Hydrochloride [vandf]

90. Ncgc00094732-01

91. Ncgc00094732-02

92. Ncgc00094732-03

93. Ncgc00094732-04

94. As-16861

95. Naphazoline Hydrochloride [usp-rs]

96. Naphazoline Hydrochloride [who-dd]

97. 2-(naphthalen-1-ylmethyl)-4,5-dihydro-

98. Wln: L66j B1- Bt5m Cn Butj &gh

99. Ft-0603466

100. Lt00114215

101. Lt00233108

102. N0542

103. Sw196701-3

104. C07898

105. D00743

106. H12006

107. Naphazoline Hydrochloride [ep Impurity]

108. Naphazoline Hydrochloride [ep Monograph]

109. Naphazoline Hydrochloride [orange Book]

110. Naphazoline Hydrochloride [usp Monograph]

111. A830484

112. Opcon-a Component Naphazoline Hydrochloride

113. Visine-a Component Naphazoline Hydrochloride

114. Naphcon-a Component Naphazoline Hydrochloride

115. Sr-01000000067-3

116. Vasocon-a Component Naphazoline Hydrochloride

117. W-105587

118. Naphazoline Hydrochloride Component Of Opcon-a

119. Naphazoline Hydrochloride Component Of Visine-a

120. Q27887678

121. Naphazoline Hydrochloride Component Of Naphcon-a

122. Naphazoline Hydrochloride Component Of Vasocon-a

123. 4,5-dihydro-2-(1-naphthylmethyl)-1h-imidazole Hydrochloride

124. 1h-imidazole,5-dihydro-2-(1-naphthalenylmethyl)-, Monohydrochloride

125. Hydron;2-(naphthalen-1-ylmethyl)-4,5-dihydro-1h-imidazole;chloride

126. 1h-imidazole, 4,5-dihydro-2-(1-naphthalenylmethyl)-, Hydrochloride (1:1)

127. Naphazoline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

128. Naphazoline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

2.3.3 Other Synonyms

1. Naphazoline

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₁₅ClN₂
Molecular Weight	246.73 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	2
Exact Mass	246.0923762 g/mol
Monoisotopic Mass	246.0923762 g/mol
Topological Polar Surface Area	24.4 Å²
Heavy Atom Count	17
Formal Charge	0
Complexity	272
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	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Naphazoline hydrochloride
Drug Label	Naphazoline Hydrochloride, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. It occurs as a white, odorless crystalline powder having a bitter taste and is freely soluble in water and in alcohol. The active ingredient is...
Active Ingredient	Naphazoline hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.1%
Market Status	Prescription
Company	Akorn

2 of 2
Drug Name	Naphazoline hydrochloride
Drug Label	Naphazoline Hydrochloride, an ocular vasoconstrictor, is an imidazoline derivative sympathomimetic amine. It occurs as a white, odorless crystalline powder having a bitter taste and is freely soluble in water and in alcohol. The active ingredient is...
Active Ingredient	Naphazoline hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.1%
Market Status	Prescription
Company	Akorn

4.2 Therapeutic Uses

Adrenergic alpha-Agonists; Nasal Decongestants

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

Naphazoline is applied topically to the conjunctiva to temporarily relieve congestion, itching, and minor irritation. Ocular decongestants are ineffective in the treatment of delayed hypersensitivity reactions such as contact dermatoconjunctivitis. The vasoconstrictor effects of naphazoline may be used during some ocular diagnostic procedures, but some clinicians prefer phenylephrine to naphazoline for this use.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2823

Ophthalmic solutions containing naphazoline in combination with antihistamines such as antazoline phosphate or pheniramine maleate and/or astringents such as zinc sulfate are commercially available. In the concentrations usually employed, zinc sulfate is a relatively ineffective antiseptic and may promote vasodilation.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824

Adrenergic (vasoconstrictor); decongestant.

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1142

Naphazoline hydrochloride (0.1%), an imidazole derivative with preferential alpha-2 activity, /was instilled/ in 17 eyes of 12 patients with myopathic ptosis due to involvement of the levator palpebrae superioris, in the attempt to selectively stimulate Muller's smooth muscle. Naphazoline significantly widened the palpebral fissure with little change in pupillary diameter and no significant change in ocular pressure, visual acuity and near point determination. However, a reduction of the effect, probably due to tachyphylaxis, was noticed when using naphazoline regularly several times a day for few weeks. In conclusion naphazoline has powerful cosmetical and functional effects in mild to moderate myopathic ptosis above all if taken occasionally.

PMID:8503264 Uncini A et al; Acta Neurol Scand 87 (4): 322-4 (1993)

4.3 Drug Warning

Ophthalmic use of naphazoline may occasionally cause systemic sympathomimetic effects such as headache, hypertension, cardiac irregularities, nervousness, nausea, dizziness, weakness, and sweating.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824

Use of naphazoline in the eye may cause blurred vision, mild transient stinging and/or irritation, mydriasis, and increased or decreased intraocular pressure. Conjunctival application of naphazoline, especially when high concentrations are used in geriatric patients, may liberate pigment granules, presumably from the iris. Rebound congestion, characterized by reactive hyperemia frequently occurs with prolonged use and may result in overuse of the drug. Prolonged use of the drug should be avoided for these reasons.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824

The incidence of serious adverse effects is low in patients receiving therapeutic dosages of ophthalmic solutions of naphazoline hydrochloride. When naphazoline hydrochloride is used in combination preparations, the cautions applicable to each ingredient in the formulation must be observed. Excessive dosage and/or prolonged or too frequent use may irritate the conjunctiva and, especially in children, cause adverse systemic effects.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824

Naphazoline hydrochloride ophthalmic solution should be used with caution in patients with hypertension, cardiovascular abnormalities, diabetes mellitus, hyperthyroidism, infection, or injury.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824

For more Drug Warnings (Complete) data for NAPHAZOLINE HYDROCHLORIDE (14 total), please visit the HSDB record page.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Adrenergic alpha-Agonists

Drugs that selectively bind to and activate alpha adrenergic receptors. (See all compounds classified as Adrenergic alpha-Agonists.)

Nasal Decongestants

Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)

5.2 Absorption, Distribution and Excretion

Following topical application of naphazoline hydrochloride solutions to the conjunctiva, local vasoconstriction usually occurs within 10 minutes and may persist for 2-6 hours. Occasionally, enough naphazoline may be absorbed to produce systemic effects. Information on the distribution and elimination of the drug in humans is not available

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824

5.3 Mechanism of Action

Naphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha-adrenergic receptors in the arterioles of the conjunctiva, resulting in decreased conjunctival congestion.

Physician's Desk Reference for Ophthalmic Medicines. 35rd Edition.Thomson PDR. Montvale, NJ. p. 219 (2006)

The mechanism of action of naphazoline has not been conclusively determined. Most pharmacologists believe that the drug directly stimulates alpha-adrenergic receptors of the sympathetic nervous system and exerts little or no effect on beta-adrenergic receptors. Following topical application of naphazoline to the conjunctiva, small arterioles are constricted and conjunctival congestion is temporarily relieved, but reactive hyperemia may occur. The drug also may produce mydriasis when applied to the conjunctiva, but this effect is usually minimal with the concentrations used as ocular decongestants.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824

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API Reference Price

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INCHEON INT\\'","customer":"CONSIGNEE","customerCountry":"REPUBLIC OF KOREA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"400","totalValueFC":"19597.5","currency":"USD","unitRateINR":32934.239999999998,"date":"21-Oct-2024","totalValueINR":"1646712","totalValueInUsd":"19597.5","indian_port":"Bombay Air","hs_no":"29214590","bill_no":"4986165","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"11\/58-B, MOHAN C.H.S., GOVIND, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729708200,"product":"NAPHAZOLINE HYDROCHLORIDE PH EUR","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"MICRO LABS LIMITED","supplierCountry":"INDIA","foreign_port":"BELEM,PA","customer":"ESENSA D.O.O","customerCountry":"SERBIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1750","totalValueFC":"1629","currency":"USD","unitRateINR":136878.26000000001,"date":"24-Oct-2024","totalValueINR":"136878.26","totalValueInUsd":"1629","indian_port":"Bangalore Air","hs_no":"29332990","bill_no":"5086378","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SERBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bangalore Air","supplierAddress":"NO 31, RACE COURSE ROAD,BANGALORE, BENGALURU,KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"NAPHAZOLINE HCL USP","address":"209, JHALAWAR,,PATANWALA ESTATE,","city":"MUMBAI,MAHARASHTRA","supplier":"PRECISE BIO PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"BOGOTA","customer":"TO THE ORDER OF...","customerCountry":"COLOMBIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"600","totalValueFC":"1047.4","currency":"USD","unitRateINR":44002.699999999997,"date":"28-Oct-2024","totalValueINR":"88005.4","totalValueInUsd":"1047.4","indian_port":"Bombay Air","hs_no":"29332910","bill_no":"5187269","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"COLOMBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"209, JHALAWAR,,PATANWALA ESTATE,, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730658600,"product":"NAPHAZOLINE HYDROCHLORIDE USP ( NPZ3O24004 (MFG DATE 03-24 EXP DATE 02-29) ) ( KG ) ( QTY- 25.000 ) TAX INV NO: 71520142","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"MICRO LABS LIMITED","supplierCountry":"INDIA","foreign_port":"NEW YORK - 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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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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.02675%...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.02675%;0.315%

USFDA APPLICATION NUMBER - 20065

DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.025%;0...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.025%;0.3%

USFDA APPLICATION NUMBER - 20485

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ABOUT THIS PAGE

Naphazoline Hydrochloride Manufacturers

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

Naphazoline Hydrochloride Suppliers

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

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

Naphazoline Hydrochloride USDMF

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

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

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

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

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

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

Naphazoline Hydrochloride CEP

A Naphazoline Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Naphazoline Hydrochloride Certificate of Suitability (COS). The purpose of a Naphazoline Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naphazoline Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naphazoline Hydrochloride to their clients by showing that a Naphazoline Hydrochloride CEP has been issued for it. The manufacturer submits a Naphazoline Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naphazoline Hydrochloride CEP holder for the record. Additionally, the data presented in the Naphazoline Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naphazoline Hydrochloride DMF.

A Naphazoline Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naphazoline Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Naphazoline Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Naphazoline Hydrochloride WC

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

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

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

Finished drug products

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

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

Naphazoline Hydrochloride GMP

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

Naphazoline Hydrochloride CoA

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

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

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