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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
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
| Molecular Weight | 432.5 g/mol |
|---|---|
| Molecular Formula | C17H28N4O7S |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 9 |
| Exact Mass | 432.16787042 g/mol |
| Monoisotopic Mass | 432.16787042 g/mol |
| Topological Polar Surface Area | 183 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 429 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 8 | |
|---|---|
| Drug Name | Timoptic-xe |
| Drug Label | TIMOPTIC-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 Ingredient | Timolol maleate |
| Dosage Form | Solution, gel forming/drops |
| Route | Ophthalmic |
| Strength | eq 0.25% base; eq 0.5% base |
| Market Status | Prescription |
| Company | Valeant Pharms |
| 2 of 8 | |
|---|---|
| Drug Name | Timolol maleate |
| Active Ingredient | Timolol maleate |
| Dosage Form | Solution/drops; Tablet; Solution, gel forming/drops |
| Route | Ophthalmic; Oral |
| Strength | eq 0.25% base; 5mg; 10mg; eq 0.5% base; 20mg |
| Market Status | Prescription |
| Company | Wockhardt; Falcon Pharms; Pacific Pharma; Hi Tech Pharma; Bausch And Lomb; Fdc; Mylan; Akorn |
| 3 of 8 | |
|---|---|
| Drug Name | Timoptic |
| Drug Label | Timolol 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 Ingredient | Timolol maleate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.25% base; eq 0.5% base |
| Market Status | Prescription |
| Company | Aton |
| 4 of 8 | |
|---|---|
| Drug Name | Timoptic in ocudose |
| PubMed Health | Timolol (Into the eye) |
| Drug Classes | Antiglaucoma |
| Drug Label | TIMOPTIC-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 Ingredient | Timolol maleate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.25% base; eq 0.5% base |
| Market Status | Prescription |
| Company | Aton |
| 5 of 8 | |
|---|---|
| Drug Name | Timoptic-xe |
| Drug Label | TIMOPTIC-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 Ingredient | Timolol maleate |
| Dosage Form | Solution, gel forming/drops |
| Route | Ophthalmic |
| Strength | eq 0.25% base; eq 0.5% base |
| Market Status | Prescription |
| Company | Valeant Pharms |
| 6 of 8 | |
|---|---|
| Drug Name | Timolol maleate |
| Active Ingredient | Timolol maleate |
| Dosage Form | Solution/drops; Tablet; Solution, gel forming/drops |
| Route | Ophthalmic; Oral |
| Strength | eq 0.25% base; 5mg; 10mg; eq 0.5% base; 20mg |
| Market Status | Prescription |
| Company | Wockhardt; Falcon Pharms; Pacific Pharma; Hi Tech Pharma; Bausch And Lomb; Fdc; Mylan; Akorn |
| 7 of 8 | |
|---|---|
| Drug Name | Timoptic |
| Drug Label | Timolol 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 Ingredient | Timolol maleate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.25% base; eq 0.5% base |
| Market Status | Prescription |
| Company | Aton |
| 8 of 8 | |
|---|---|
| Drug Name | Timoptic in ocudose |
| PubMed Health | Timolol (Into the eye) |
| Drug Classes | Antiglaucoma |
| Drug Label | TIMOPTIC-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 Ingredient | Timolol maleate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.25% base; eq 0.5% base |
| Market Status | Prescription |
| Company | Aton |
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.)
API SUPPLIERS
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Date of Issue : 2022-07-08
Valid Till : 2024-11-04
Written Confirmation Number : WC-0432
Address of the Firm :
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Registration Number : 306MF10098
Registrant's Address : 21,chemin de la Sauvegarde 21 Ecully Parc - CS 33167 69134 Ecully Cedex France
Initial Date of Registration : 2024-07-17
Latest Date of Registration : --
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-27
Pay. Date : 2017-01-23
DMF Number : 29342
Submission : 2015-07-07
Status : Active
Type : II
NDC Package Code : 51014-7125
Start Marketing Date : 2015-05-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2023-11-23
Registration Number : 20231123-201-I-665-10
Manufacturer Name : PCAS Finland Oy
Manufacturer Address : Messukentankatu 8, 20210 Turku, Finland
| Available Reg Filing : ASMF |
Jai Radhe Sales is your partner for all your sourcing needs.
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Certificate Number : CEP 1996-049 - Rev 07
Status : Valid
Issue Date : 2023-10-16
Type : Chemical
Substance Number : 572
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Certificate Number : CEP 2014-300 - Rev 01
Status : Valid
Issue Date : 2023-09-27
Type : Chemical
Substance Number : 572
TAPI offers customized CDMO Solutions for API development and manufacturing services.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
Certificate Number : R1-CEP 1998-147 - Rev 11
Status : Valid
Issue Date : 2022-03-24
Type : Chemical
Substance Number : 572
Certificate Number : CEP 2010-084 - Rev 03
Status : Valid
Issue Date : 2023-10-19
Type : Chemical
Substance Number : 572
Certificate Number : CEP 2021-304 - Rev 00
Status : Valid
Issue Date : 2024-04-24
Type : Chemical
Substance Number : 572
Certificate Number : R1-CEP 2001-296 - Rev 05
Status : Valid
Issue Date : 2023-07-05
Type : Chemical
Substance Number : 572
Certificate Number : R1-CEP 2003-070 - Rev 03
Status : Valid
Issue Date : 2020-09-15
Type : Chemical
Substance Number : 572
Certificate Number : R0-CEP 2022-322 - Rev 00
Status : Valid
Issue Date : 2023-06-28
Type : Chemical
Substance Number : 572
Certificate Number : R1-CEP 2003-239 - Rev 05
Status : Valid
Issue Date : 2021-03-16
Type : Chemical
Substance Number : 572
Certificate Number : R1-CEP 2005-065 - Rev 00
Status : Valid
Issue Date : 2012-05-24
Type : Chemical
Substance Number : 572
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25%...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25% BASE
USFDA APPLICATION NUMBER - 18086
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE
USFDA APPLICATION NUMBER - 18086
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25%...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.25% BASE
USFDA APPLICATION NUMBER - 19463
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE
USFDA APPLICATION NUMBER - 19463
DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALM...DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALMIC - EQ 0.25% BASE
USFDA APPLICATION NUMBER - 20330
DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALM...DOSAGE - SOLUTION, GEL FORMING/DROPS;OPHTHALMIC - EQ 0.5% BASE
USFDA APPLICATION NUMBER - 20330
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BA...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE;EQ 0.5% BASE
USFDA APPLICATION NUMBER - 20869
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
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.
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.
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.
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.
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.
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.
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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.
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).
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.
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.
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 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.
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).
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