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1. 4-ethylamino-5,6-dihydro-6-methyl-7,7-dioxide-4h-thieno(2,3-b)thiopyran-2-sulfonamide
2. 5,6-dihydro-4-ethylamino-6-methyl-4h-thieno(2,3-b)thiopyran-2-sulfonamide-7,7-dioxide
3. Dorzolamide
4. Dorzolamide Chibret
5. Dorzolamide, (trans)-isomer
6. L 671152
7. L-671,152
8. Mk 507
9. Mk-507
10. Trusopt
1. 130693-82-2
2. Dorzolamide Hcl
3. Trusopt
4. Dorzolomide Hydrochloride
5. Cosopt
6. Dorzolamide (hydrochloride)
7. Mk-507
8. Dorzolomide Hcl
9. (4s,6s)-4-(ethylamino)-6-methyl-5,6-dihydro-4h-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide Hydrochloride
10. Dorzolamide (as Hydrochloride)
11. Qzo5366ew7
12. Trusopt (tn)
13. Dsstox_cid_25530
14. Dsstox_rid_80933
15. Dsstox_gsid_45530
16. (4s,6s)-4-(ethylamino)-5,6-dihydro-6-methyl-4h-thieno(2,3-b)thiopyran-2-sulfonamide 7,7-dioxide, Monohydrochloride
17. Chebi:4703
18. (4s,6s)-4-(ethylamino)-6-methyl-7,7-dioxo-5,6-dihydro-4h-thieno[2,3-b]thiopyran-2-sulfonamide;hydrochloride
19. 4h-thieno(2,3-b)thiopyran-2-sulfonamide, 4-(ethylamino)-5,6-dihydro-6-methyl-, 7,7-dioxide, Monohydrochloride, (4s-trans)-
20. Unii-qzo5366ew7
21. Sr-05000001449
22. Dorzolamide Hydrochloride [usan]
23. L 671152
24. L-671,152
25. Dorzolamide Hcl Salt
26. Dorzolamide Hydrochloride [usan:usp]
27. Mk507 Hydrochloride
28. Mk 0507
29. Mk-0507
30. L671152 Hydrochloride
31. Ncgc00016977-01
32. Cas-130693-82-2
33. Schembl41152
34. Mls002154162
35. Chembl1201162
36. Dtxsid1045530
37. Dorzolamide Hydrochloride- Bio-x
38. Hy-b0109a
39. Hms1571o14
40. Ex-a3987
41. Tox21_110720
42. Mfcd00884659
43. S1375
44. Dorzolamide Hydrochloride [mi]
45. Akos005146235
46. Akos015895951
47. Dorzolamide Hydrochloride (jp17/usp)
48. Tox21_110720_1
49. Ac-5244
50. Ccg-221116
51. Cs-1858
52. Dorzolamide Hydrochloride [jan]
53. Ks-1348
54. Dorzolamide Hydrochloride [mart.]
55. Dorzolamide Hydrochloride [vandf]
56. Ncgc00179244-03
57. Bd164381
58. Dorzolamide Hydrochloride [usp-rs]
59. Dorzolamide Hydrochloride [who-dd]
60. Smr001233461
61. Mk-507 (l-671152) Hcl
62. D4189
63. Dorzolamide Hydrochloride, Trans-(-)-
64. C72221
65. D00653
66. Dorzolamide Hydrochloride [orange Book]
67. Dorzolamide Hydrochloride [usp Impurity]
68. Cosopt Component Dorzolamide Hydrochloride
69. Dorzolamide Hydrochloride [usp Monograph]
70. 279d961
71. Dorzolamide Hydrochloride Component Of Cosopt
72. L-671152
73. Sr-05000001449-3
74. Q27106441
75. Dorzolamide Hydrochloride, European Pharmacopoeia (ep) Reference Standard
76. Dorzolamide For System Suitability, European Pharmacopoeia (ep) Reference Standard
77. Dorzolamide Hydrochloride, United States Pharmacopeia (usp) Reference Standard
78. (4s,6s)-4-(ethylamino)-5,6-dihydro-6-methyl-, 7,7-dioxide 4h-thieno[2,3-b]thiopyran-2-sulfonamide Hydrochloride
79. 122028-16-4
80. 4h-thieno(2,3-b)thiopyran-2-sulfonamide, 5,6-dihydro-4-(ethylamino)-6-methyl-, 7,7-dioxide, Monohydrochloride, (4s,6s)-
Molecular Weight | 360.9 g/mol |
---|---|
Molecular Formula | C10H17ClN2O4S3 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 3 |
Exact Mass | 360.0038982 g/mol |
Monoisotopic Mass | 360.0038982 g/mol |
Topological Polar Surface Area | 151 Ų |
Heavy Atom Count | 20 |
Formal Charge | 0 |
Complexity | 534 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Cosopt |
PubMed Health | Dorzolamide/Timolol (Into the eye) |
Drug Classes | Antiglaucoma, Beta-Adrenergic Blocker/Carbonic Anhydrase Inhibitor Combination |
Active Ingredient | Dorzolamide hydrochloride; timolol maleate |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | eq 0.5% base; eq 2% base |
Market Status | Prescription |
Company | Oak Pharms Akorn |
2 of 4 | |
---|---|
Drug Name | Dorzolamide hydrochloride |
Drug Label | Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.Dorzolamide hydrochloride, USP is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]th... |
Active Ingredient | Dorzolamide hydrochloride |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | eq 2% base |
Market Status | Prescription |
Company | Watson Labs; Zach Systems; Teva Pharms; Hi Tech Pharma; Bausch And Lomb; Alcon Pharms; Luitpold; Sandoz |
3 of 4 | |
---|---|
Drug Name | Cosopt |
PubMed Health | Dorzolamide/Timolol (Into the eye) |
Drug Classes | Antiglaucoma, Beta-Adrenergic Blocker/Carbonic Anhydrase Inhibitor Combination |
Active Ingredient | Dorzolamide hydrochloride; timolol maleate |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | eq 0.5% base; eq 2% base |
Market Status | Prescription |
Company | Oak Pharms Akorn |
4 of 4 | |
---|---|
Drug Name | Dorzolamide hydrochloride |
Drug Label | Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% is a carbonic anhydrase inhibitor formulated for topical ophthalmic use.Dorzolamide hydrochloride, USP is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]th... |
Active Ingredient | Dorzolamide hydrochloride |
Dosage Form | Solution/drops |
Route | Ophthalmic |
Strength | eq 2% base |
Market Status | Prescription |
Company | Watson Labs; Zach Systems; Teva Pharms; Hi Tech Pharma; Bausch And Lomb; Alcon Pharms; Luitpold; Sandoz |
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.)
Carbonic Anhydrase Inhibitors
A class of compounds that reduces the secretion of H+ ions by the proximal kidney tubule through inhibition of CARBONIC ANHYDRASES. (See all compounds classified as Carbonic Anhydrase Inhibitors.)
Bhavna Laboratories is an API & Intermediate manufacturer focusing on the muscle relaxant & ophthalmic segments.
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34797
Submission : 2020-07-22
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Certificate Number : R1-CEP 2012-023 - Rev 01
Issue Date : 2020-07-30
Type : Chemical
Substance Number : 2359
Status : Withdrawn by Holder
Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-24
Pay. Date : 2020-01-08
DMF Number : 33024
Submission : 2018-11-19
Status : Active
Type : II
Certificate Number : R1-CEP 2008-155 - Rev 03
Issue Date : 2021-09-07
Type : Chemical
Substance Number : 2359
Status : Valid
NDC Package Code : 58032-0142
Start Marketing Date : 2017-11-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : BASH HEALTH KOREA CORP.
Registration Date : 2023-04-20
Registration Number : 20230420-209-J-1481
Manufacturer Name : Neuland Laboratories Limited
Manufacturer Address : Unit-I, Sy. No: 347, 473, 474, 490/2, Veerabhadraswamy Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy District - 502 313, Telangana, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 20441
Submission : 2007-04-19
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
Certificate Number : R1-CEP 2012-023 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2020-07-30
Type : Chemical
Substance Number : 2359
Dorzolamide Hydrochloride, Process II
Certificate Number : R1-CEP 2017-089 - Rev 00
Status : Valid
Issue Date : 2022-08-22
Type : Chemical
Substance Number : 2359
Certificate Number : R1-CEP 2008-155 - Rev 03
Status : Valid
Issue Date : 2021-09-07
Type : Chemical
Substance Number : 2359
Certificate Number : R1-CEP 2010-115 - Rev 03
Status : Valid
Issue Date : 2021-11-15
Type : Chemical
Substance Number : 2359
Certificate Number : R1-CEP 2008-308 - Rev 03
Status : Valid
Issue Date : 2019-03-25
Type : Chemical
Substance Number : 2359
Dorzolamide Hydrochloride, Process 2
Certificate Number : CEP 2023-236 - Rev 00
Status : Valid
Issue Date : 2023-09-07
Type : Chemical
Substance Number : 2359
Certificate Number : R1-CEP 2014-288 - Rev 00
Status : Valid
Issue Date : 2021-03-02
Type : Chemical
Substance Number : 2359
Certificate Number : CEP 2017-050 - Rev 02
Status : Valid
Issue Date : 2023-11-28
Type : Chemical
Substance Number : 2359
Dorzolamide Hydrochloride, Process II
Certificate Number : R0-CEP 2019-286 - Rev 00
Status : Valid
Issue Date : 2020-03-10
Type : Chemical
Substance Number : 2359
Certificate Number : R1-CEP 2009-093 - Rev 03
Status : Valid
Issue Date : 2022-01-05
Type : Chemical
Substance Number : 2359
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Solution
Dosage Strength : 20MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Regulatory Info :
Registration Country : Italy
Brand Name : DORZOLAMIDE AND TIMOLOL THINK
Dosage Form : Eye Drops, Solution
Dosage Strength : 20 mg/ml+5 mg/ml
Packaging : 5 ML 2% + 0.5% - OPHTHALMIC USE SOLUTION
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : DORZOLAMIDE TIMOLOL EG
Dosage Form : Eye Drops, Solution
Dosage Strength : 20 mg/ml+5 mg/ml
Packaging : 5 ML 2% + 0.5% - OPHTHALMIC USE SOLUTION
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : DORZOCLAR
Dosage Form : Eye Drops, Solution
Dosage Strength : 20 mg/ml
Packaging : 5 ML 20 MG/ML - OPHTHALMIC USE SOLUTION
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : DorzoComp-Vision
Dosage Form : Gtt Opht
Dosage Strength : 20mg/ml and 5mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Several substances refer to content
Brand Name : COSOPT
Dosage Form : EYE DROPS, SOLUTION
Dosage Strength : 20 MG / ML + 5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Several substances refer to content
Brand Name : COSOPT
Dosage Form : EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINERS
Dosage Strength : 20 MG / ML + 5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Trusopt
Dosage Form : Eye drops, resolution
Dosage Strength : 20 mg/ml
Packaging : Bottle of plastic with dropping tip
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : Dorzolamide Tololo
Dosage Form : Dorzolamide+Timolol 2%+0.5% 5Ml Solution Ophthalmic Use
Dosage Strength : EYE DROPS 5 ML 20 mg/ml + 5 mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Trusopt
Dosage Form : EYE DROPS, SOLUTION
Dosage Strength : 20 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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ABOUT THIS PAGE
A Dorzolamide Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dorzolamide Hydrochloride, including repackagers and relabelers. The FDA regulates Dorzolamide Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dorzolamide 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 Dorzolamide Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dorzolamide Hydrochloride supplier is an individual or a company that provides Dorzolamide Hydrochloride active pharmaceutical ingredient (API) or Dorzolamide Hydrochloride finished formulations upon request. The Dorzolamide Hydrochloride suppliers may include Dorzolamide Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dorzolamide Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dorzolamide Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dorzolamide Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dorzolamide Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dorzolamide Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dorzolamide Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dorzolamide Hydrochloride USDMF includes data on Dorzolamide Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dorzolamide Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dorzolamide Hydrochloride 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 Dorzolamide Hydrochloride Drug Master File in Japan (Dorzolamide Hydrochloride JDMF) empowers Dorzolamide Hydrochloride 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 Dorzolamide Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Dorzolamide Hydrochloride 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 Dorzolamide Hydrochloride 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 Dorzolamide Hydrochloride Drug Master File in Korea (Dorzolamide Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dorzolamide Hydrochloride. The MFDS reviews the Dorzolamide Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Dorzolamide Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dorzolamide 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 Dorzolamide Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dorzolamide Hydrochloride suppliers with KDMF on PharmaCompass.
A Dorzolamide Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Dorzolamide Hydrochloride Certificate of Suitability (COS). The purpose of a Dorzolamide Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dorzolamide Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dorzolamide Hydrochloride to their clients by showing that a Dorzolamide Hydrochloride CEP has been issued for it. The manufacturer submits a Dorzolamide Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dorzolamide Hydrochloride CEP holder for the record. Additionally, the data presented in the Dorzolamide Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dorzolamide Hydrochloride DMF.
A Dorzolamide Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dorzolamide 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 Dorzolamide Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Dorzolamide Hydrochloride written confirmation (Dorzolamide Hydrochloride WC) is an official document issued by a regulatory agency to a Dorzolamide Hydrochloride manufacturer, verifying that the manufacturing facility of a Dorzolamide Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dorzolamide Hydrochloride APIs or Dorzolamide Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dorzolamide Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Dorzolamide Hydrochloride 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 Dorzolamide Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dorzolamide Hydrochloride 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 Dorzolamide 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.
The NDC directory also contains data on finished compounded human drug products that contain Dorzolamide Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dorzolamide Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dorzolamide Hydrochloride suppliers with NDC on PharmaCompass.
Dorzolamide 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 Dorzolamide 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 Dorzolamide Hydrochloride GMP manufacturer or Dorzolamide Hydrochloride GMP API supplier for your needs.
A Dorzolamide Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Dorzolamide Hydrochloride's compliance with Dorzolamide Hydrochloride specifications and serves as a tool for batch-level quality control.
Dorzolamide Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Dorzolamide 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.
Dorzolamide Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dorzolamide Hydrochloride EP), Dorzolamide Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dorzolamide Hydrochloride USP).
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