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Chemistry

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Also known as: 26921-17-5, (s)-timolol maleate, Timolol maleate salt, Blocadren, Timoptic, Timolol hydrogen maleate
Molecular Formula
C17H28N4O7S
Molecular Weight
432.5  g/mol
InChI Key
WLRMANUAADYWEA-NWASOUNVSA-N
FDA UNII
P8Y54F701R

Timolol Maleate
A beta-adrenergic antagonist that is similar in action to PROPRANOLOL; the levo-isomer is more active. Timolol has been proposed as an anti-hypertensive, anti-arrhythmic, anti-angina, and anti-glaucoma agent. It is also used in the treatment of MIGRAINE DISORDERS and tremor.
1 2D Structure

Timolol Maleate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(Z)-but-2-enedioic acid;(2S)-1-(tert-butylamino)-3-[(4-morpholin-4-yl-1,2,5-thiadiazol-3-yl)oxy]propan-2-ol
2.1.2 InChI
InChI=1S/C13H24N4O3S.C4H4O4/c1-13(2,3)14-8-10(18)9-20-12-11(15-21-16-12)17-4-6-19-7-5-17;5-3(6)1-2-4(7)8/h10,14,18H,4-9H2,1-3H3;1-2H,(H,5,6)(H,7,8)/b;2-1-/t10-;/m0./s1
2.1.3 InChI Key
WLRMANUAADYWEA-NWASOUNVSA-N
2.1.4 Canonical SMILES
CC(C)(C)NCC(COC1=NSN=C1N2CCOCC2)O.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CC(C)(C)NC[C@@H](COC1=NSN=C1N2CCOCC2)O.C(=C\C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
P8Y54F701R
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (s)-1-((1,1-dimethylethyl)amino)-3-((4-(4-morpholinyl)-1,2,5-thiadazol-3-yl)oxy)-2-propanol

2. 2-propanol, 1-((1,1-dimethylethyl)amino)-3-((4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-, (s)-

3. Blocadren

4. L 714,465

5. L-714,465

6. L714,465

7. Mk 950

8. Mk-950

9. Mk950

10. Optimol

11. Timacar

12. Timolol

13. Timolol Hemihydrate

14. Timolol Maleate, (1:1) Salt

15. Timoptic

16. Timoptol

2.3.2 Depositor-Supplied Synonyms

1. 26921-17-5

2. (s)-timolol Maleate

3. Timolol Maleate Salt

4. Blocadren

5. Timoptic

6. Timolol Hydrogen Maleate

7. Istalol

8. (s)-timolol (maleate)

9. (s)-timolol Hydrogen Maleate

10. Timoptic-xe

11. Ophtamolol

12. Aquanil

13. Mk 950

14. Timolol (as Maleate)

15. Timolol Hydrogen Maleate Salt

16. Timolol Maleate, S-enantiomer

17. Wp-934

18. Mls000028539

19. Chebi:9600

20. 60469-65-0

21. P8y54f701r

22. (-)-1-(tert-butylamino)-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)-2-propanol Maleate

23. Nsc-757351

24. (-)-1-(tert-butylamino)-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)-2-propanol Maleate (1:1) (salt)

25. (z)-but-2-enedioic Acid;(2s)-1-(tert-butylamino)-3-[(4-morpholin-4-yl-1,2,5-thiadiazol-3-yl)oxy]propan-2-ol

26. 2-propanol, 1-((1,1-dimethylethyl)amino)-3-((4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl)oxy)-, (s)-, (z)-2-butenedioate (1:1) (salt)

27. Smr000058305

28. Timacor

29. Betime

30. L-timolol Maleate

31. Timoptic In Ocudose

32. Mfcd00058356

33. 2-propanol, 1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-, (2s)-, (2z)-2-butenedioate (salt)

34. Ccris 1057

35. Einecs 248-111-5

36. Cas-26921-17-5

37. (s)-(-)-timolol Maleate

38. Timololmaleate

39. Timololi Maleas

40. Unii-p8y54f701r

41. S-timolol Maleate

42. Blocadren (tn)

43. Timolol Maleate [usan:usp:jan]

44. Timoptic (tn)

45. Einecs 262-251-4

46. Istalol (tn)

47. Bimatoprost / Timolol

48. Timolol Hydrogenmaleate

49. Opera_id_1256

50. Dsstox_cid_27504

51. Dsstox_rid_82384

52. Dsstox_gsid_47504

53. Schembl26233

54. Mls001076135

55. Timolol Maleate [jan]

56. Timolol Maleate (jp17/usp)

57. Timolol Maleate [usan]

58. L-714,465 (maleate)

59. Timolol Maleate [vandf]

60. Chembl1200870

61. Dtxsid3047504

62. Timolol Maleate [mart.]

63. Timolol Maleate [usp-rs]

64. Timolol Maleate [who-dd]

65. Timolol Maleate [who-ip]

66. Hms1570n18

67. Hms2097n18

68. Hms2230n19

69. Hms2234f03

70. Hms3411m12

71. Hms3675m12

72. Hms3714n18

73. Hms3885l05

74. Tox21_302468

75. S4123

76. Timolol Maleate [orange Book]

77. Akos024458595

78. Timolol Maleate [ep Monograph]

79. Timolol Maleate [usp Impurity]

80. Ccg-220948

81. Cosopt Component Timolol Maleate

82. Cs-1028

83. Nsc 757351

84. Timolol Maleate [usp Monograph]

85. Timololi Maleas [who-ip Latin]

86. (s)-3-(3-(tert-butylamino)-2-hydroxypropoxy)-4-morpholino-1,2,5-thiadiazole Maleate

87. Duotrav Component Timolol Maleate

88. Ganfort Component Timolol Maleate

89. Xalacom Component Timolol Maleate

90. Combigan Component Timolol Maleate

91. Ncgc00256737-01

92. 2-propanol, 1-(tert-butylamino)-3-((4-morpholino-1,2,5-thiadiazol-3-yl)oxy)-, (-)-, Maleate (1:1) (salt)

93. 2-propanol, 1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-, (2s)-, (2z)-2-butenedioate (1:1) (salt)

94. As-18090

95. Bs164420

96. Hy-17380

97. Smr000653470

98. Timolol Hydrogen Maleate Salt [mi]

99. Timolol Maleate Component Of Cosopt

100. Timolol Maleate Component Of Duotrav

101. Timolol Maleate Component Of Ganfort

102. T2905

103. Timolol Maleate Component Of Combigan

104. Timolol Maleate Salt, >=98% (tlc), Powder

105. A13429

106. D00603

107. F20622

108. Timolol Maleate, S-enantiomer [who-dd]

109. 921t175

110. Sr-01000003102

111. Q-201836

112. Sr-01000003102-3

113. Q27108445

114. Timolol Maleate 1.0 Mg/ml In Methanol (as Free Base)

115. Timolol Maleate, British Pharmacopoeia (bp) Reference Standard

116. Timolol Maleate, European Pharmacopoeia (ep) Reference Standard

117. Timolol Maleate, United States Pharmacopeia (usp) Reference Standard

118. (s)-1-tert-butylamino-3-(4-morpholin-4-yl-[1,2,5]thiadiazol-3-yloxy)-propan-2-ol Maleate

119. 1-( Tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol Maleate

120. Timolol For System Suitability, European Pharmacopoeia (ep) Reference Standard

121. (2s)-1-(tert-butylamino)-3-{[4-(morpholin-4-yl)-1,2,5-thiadiazol-3-yl]oxy}propan-2-ol (2z)-but-2-enedioate

122. (s)-1-[(1,1-dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol Maleate

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 432.5 g/mol
Molecular Formula C17H28N4O7S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count12
Rotatable Bond Count9
Exact Mass432.16787042 g/mol
Monoisotopic Mass432.16787042 g/mol
Topological Polar Surface Area183 Ų
Heavy Atom Count29
Formal Charge0
Complexity429
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameTimoptic-xe
Drug LabelTIMOPTIC-XE (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3- [(4-morpholino-1, 2, 5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol malea...
Active IngredientTimolol maleate
Dosage FormSolution, gel forming/drops
RouteOphthalmic
Strengtheq 0.25% base; eq 0.5% base
Market StatusPrescription
CompanyValeant Pharms

2 of 8  
Drug NameTimolol maleate
Active IngredientTimolol maleate
Dosage FormSolution/drops; Tablet; Solution, gel forming/drops
RouteOphthalmic; Oral
Strengtheq 0.25% base; 5mg; 10mg; eq 0.5% base; 20mg
Market StatusPrescription
CompanyWockhardt; Falcon Pharms; Pacific Pharma; Hi Tech Pharma; Bausch And Lomb; Fdc; Mylan; Akorn

3 of 8  
Drug NameTimoptic
Drug LabelTimolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3- [(4-morpholino-1, 2, 5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate p...
Active IngredientTimolol maleate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.25% base; eq 0.5% base
Market StatusPrescription
CompanyAton

4 of 8  
Drug NameTimoptic in ocudose
PubMed HealthTimolol (Into the eye)
Drug ClassesAntiglaucoma
Drug LabelTIMOPTIC-XE (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3- [(4-morpholino-1, 2, 5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol malea...
Active IngredientTimolol maleate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.25% base; eq 0.5% base
Market StatusPrescription
CompanyAton

5 of 8  
Drug NameTimoptic-xe
Drug LabelTIMOPTIC-XE (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3- [(4-morpholino-1, 2, 5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol malea...
Active IngredientTimolol maleate
Dosage FormSolution, gel forming/drops
RouteOphthalmic
Strengtheq 0.25% base; eq 0.5% base
Market StatusPrescription
CompanyValeant Pharms

6 of 8  
Drug NameTimolol maleate
Active IngredientTimolol maleate
Dosage FormSolution/drops; Tablet; Solution, gel forming/drops
RouteOphthalmic; Oral
Strengtheq 0.25% base; 5mg; 10mg; eq 0.5% base; 20mg
Market StatusPrescription
CompanyWockhardt; Falcon Pharms; Pacific Pharma; Hi Tech Pharma; Bausch And Lomb; Fdc; Mylan; Akorn

7 of 8  
Drug NameTimoptic
Drug LabelTimolol Maleate Ophthalmic Gel Forming Solution is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3- [(4-morpholino-1, 2, 5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate p...
Active IngredientTimolol maleate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.25% base; eq 0.5% base
Market StatusPrescription
CompanyAton

8 of 8  
Drug NameTimoptic in ocudose
PubMed HealthTimolol (Into the eye)
Drug ClassesAntiglaucoma
Drug LabelTIMOPTIC-XE (timolol maleate ophthalmic solution) is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3- [(4-morpholino-1, 2, 5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol malea...
Active IngredientTimolol maleate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.25% base; eq 0.5% base
Market StatusPrescription
CompanyAton

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)


Adrenergic beta-Antagonists

Drugs that bind to but do not activate beta-adrenergic receptors thereby blocking the actions of beta-adrenergic agonists. Adrenergic beta-antagonists are used for treatment of hypertension, cardiac arrhythmias, angina pectoris, glaucoma, migraine headaches, and anxiety. (See all compounds classified as Adrenergic beta-Antagonists.)


Anti-Arrhythmia Agents

Agents used for the treatment or prevention of cardiac arrhythmias. They may affect the polarization-repolarization phase of the action potential, its excitability or refractoriness, or impulse conduction or membrane responsiveness within cardiac fibers. Anti-arrhythmia agents are often classed into four main groups according to their mechanism of action: sodium channel blockade, beta-adrenergic blockade, repolarization prolongation, or calcium channel blockade. (See all compounds classified as Anti-Arrhythmia Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
beta-Adrenergic Blocker [EPC]; Adrenergic beta-Antagonists [MoA]

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LTD","customerCountry":"INDIA","quantity":"18.99","actualQuantity":"18.99","unit":"KGS","unitRateFc":"2000","totalValueFC":"38498.5","currency":"USD","unitRateINR":"175600","date":"07-Mar-2025","totalValueINR":"3334644","totalValueInUsd":"38498.5","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"8759209","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"61 SOUTH PARAMUS ROAD, SUITE 565 PARAMUS, NEW JERSEY 07652 SDNF UNITED STATES OF AMERICA","customerAddress":"236, OKHLA INDUSTRIAL AREA,PHASE."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1743618600,"product":"TIMOLOLMALEATE TIMOLOLMALEATE","address":"28\/A, IDA,","city":"HYDERABAD, AP","supplier":"HOLOPACK VERPACKUNGSTECHNIK GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ARAGEN LIFE SCIENCES LTD","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"0.067","unit":"KGS","unitRateFc":"397.8","totalValueFC":"27.2","currency":"EURO","unitRateINR":"34728.5","date":"03-Apr-2025","totalValueINR":"2326.81","totalValueInUsd":"27.2","indian_port":"Hyderabad Air","hs_no":"29420021","bill_no":"9260660","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BAHNHOFSTRASSE 18 D-74429 SULZBACH-LAUFEN SDNF DE","customerAddress":"28\/A, IDA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745260200,"product":"TIMOLOL MALEATE USP TIMOLOL MALEATE USP","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"PCAS FINLAND OY","supplierCountry":"FINLAND","foreign_port":"HELSINKI","customer":"ALEMBIC PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"33.34","actualQuantity":"33.34","unit":"KGS","unitRateFc":"1300","totalValueFC":"43746.2","currency":"USD","unitRateINR":"112320","date":"22-Apr-2025","totalValueINR":"3744748.8","totalValueInUsd":"43746.2","indian_port":"Bombay Air","hs_no":"29420021","bill_no":"9638513","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"P.O.BOX 979,FI-20101 TURKU, SDNF SDNF FINLAND","customerAddress":"ALEMBIC ROAD"}]
03-Jan-2022
30-May-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25%...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25% BASE

USFDA APPLICATION NUMBER - 18086

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

USFDA APPLICATION NUMBER - 18086

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25%...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25% BASE

USFDA APPLICATION NUMBER - 19463

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

USFDA APPLICATION NUMBER - 19463

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DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALM...DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALMIC - EQ 0.25% BASE

USFDA APPLICATION NUMBER - 20330

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DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALM...DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALMIC - EQ 0.5% BASE

USFDA APPLICATION NUMBER - 20330

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BA...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE;EQ 0.5% BASE

USFDA APPLICATION NUMBER - 20869

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

USFDA APPLICATION NUMBER - 21516

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ABOUT THIS PAGE

Looking for 26921-17-5 / Timolol Maleate API manufacturers, exporters & distributors?

Timolol Maleate manufacturers, exporters & distributors 1

19

PharmaCompass offers a list of Timolol Maleate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Timolol Maleate manufacturer or Timolol Maleate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Timolol Maleate manufacturer or Timolol Maleate supplier.

PharmaCompass also assists you with knowing the Timolol Maleate API Price utilized in the formulation of products. Timolol Maleate API Price is not always fixed or binding as the Timolol Maleate Price is obtained through a variety of data sources. The Timolol Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Timolol Maleate

Synonyms

26921-17-5, (s)-timolol maleate, Timolol maleate salt, Blocadren, Timoptic, Timolol hydrogen maleate

Cas Number

26921-17-5

Unique Ingredient Identifier (UNII)

P8Y54F701R

About Timolol Maleate

A beta-adrenergic antagonist that is similar in action to PROPRANOLOL; the levo-isomer is more active. Timolol has been proposed as an anti-hypertensive, anti-arrhythmic, anti-angina, and anti-glaucoma agent. It is also used in the treatment of MIGRAINE DISORDERS and tremor.

Timolol Maleate Manufacturers

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

Timolol Maleate Suppliers

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

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

Timolol Maleate USDMF

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

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

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

Timolol Maleate JDMF

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

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

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

click here to find a list of Timolol Maleate suppliers with JDMF on PharmaCompass.

Timolol Maleate KDMF

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

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

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

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

Timolol Maleate CEP

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

A Timolol Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Timolol Maleate 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 Timolol Maleate suppliers with CEP (COS) on PharmaCompass.

Timolol Maleate WC

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

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

Timolol Maleate 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 Timolol Maleate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Timolol Maleate GMP

Timolol Maleate 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 Timolol Maleate 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 Timolol Maleate GMP manufacturer or Timolol Maleate GMP API supplier for your needs.

Timolol Maleate CoA

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

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

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