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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.)
API SUPPLIERS
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USDMF
Century has been an API manufacturer for over 40 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
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-24
Pay. Date : 2020-01-08
DMF Number : 33024
Submission : 2018-11-19
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
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DMF Number : 21519
Submission : 2008-04-09
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 20441
Submission : 2007-04-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 18385
Submission : 2005-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 20740
Submission : 2007-07-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20856
Submission : 2007-09-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21910
Submission : 2008-08-27
Status : Inactive
Type : II
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Neuland Laboratories- A dedicated 100% API provider.
Dorzolamide Hydrochloride USP/Ph.Eur
Date of Issue : 2022-06-07
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm : Unit-I, Sy. No. 347, 473, 474, 490/2, Bonthapally Village, Veerabhadraswamy Temp...
Dorzolamide Hydrochloride Ph.Eur/USP/IP/BP/JP
Date of Issue : 2022-06-18
Valid Till : 2025-07-07
Written Confirmation Number : WC-0055n
Address of the Firm : Plot No.-19 & 20/2, MIDC, Dhatav -402116, Taluka: Roha, District: Raigad
Dorzolamide Hydrochloride Ph.Eur/USP
Date of Issue : 2022-04-07
Valid Till : 2025-03-07
Written Confirmation Number : WC-0040n
Address of the Firm : Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandai, Sangareddy Dist...
Dorzolamide Hydrochloride Ph.Eur/BP/USP/JP
Date of Issue : 2022-08-25
Valid Till : 2025-08-15
Written Confirmation Number : WC-0151n
Address of the Firm : A-26, A-27, A-28/1, A-28/2, MIDC IND Area, Patalganga, Village Kaire, Tal. Khala...
Date of Issue : 2022-08-01
Valid Till : 2025-07-15
Written Confirmation Number : WC-0152n
Address of the Firm : R-92,93, First Floor, TTC Industrial Area MIDC, Thane Belapur Road, Navi Mumbai,...
Date of Issue : 2023-02-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0101
Address of the Firm : No.21M, Attibele Industrial Area, Anekal Taluk, Bangalore-562107, Karnataka, Ind...
Dorzolamide Hydrochloride Ph. Eur
Date of Issue : 2022-08-11
Valid Till : 2025-08-15
Written Confirmation Number : WC-0225
Address of the Firm : Plot No. 43 to 45, KIADB, Bommasandra Industrial area, 4th phase, Anekal taluk, ...
Date of Issue : 2022-08-11
Valid Till : 2025-08-15
Written Confirmation Number : WC-0225
Address of the Firm : Plot No. 43 to 45, KIADB, Bommasandra Industrial area, 4th phase, Anekal taluk, ...
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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
NDC Package Code : 51014-7777
Start Marketing Date : 2009-10-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Neuland Laboratories- A dedicated 100% API provider.
NDC Package Code : 58032-0142
Start Marketing Date : 2017-11-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63415-0118
Start Marketing Date : 2017-11-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 73377-182
Start Marketing Date : 2022-08-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 65089-0039
Start Marketing Date : 1994-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52133-0031
Start Marketing Date : 1994-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 52133-0031
Start Marketing Date : 1994-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 55545-0703
Start Marketing Date : 2018-12-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65977-0031
Start Marketing Date : 1994-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 42571-157
Start Marketing Date : 2011-02-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BA...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 2% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20408
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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PharmaCompass offers a list of Dorzolamide Hydrochloride 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 Dorzolamide Hydrochloride manufacturer or Dorzolamide Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dorzolamide Hydrochloride manufacturer or Dorzolamide Hydrochloride supplier.
PharmaCompass also assists you with knowing the Dorzolamide Hydrochloride API Price utilized in the formulation of products. Dorzolamide Hydrochloride API Price is not always fixed or binding as the Dorzolamide Hydrochloride Price is obtained through a variety of data sources. The Dorzolamide Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, including repackagers and relabelers. The FDA regulates DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE supplier is an individual or a company that provides DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE active pharmaceutical ingredient (API) or DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE finished formulations upon request. The DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE suppliers may include DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE API manufacturers, exporters, distributors and traders.
click here to find a list of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DMF (Drug Master File) is a document detailing the whole manufacturing process of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE active pharmaceutical ingredient (API) in detail. Different forms of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DMFs exist exist since differing nations have different regulations, such as DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DMF submitted to regulatory agencies in the US is known as a USDMF. DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE USDMF includes data on DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Drug Master File in Japan (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE JDMF) empowers DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE JDMF during the approval evaluation for pharmaceutical products. At the time of DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Drug Master File in Korea (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE. The MFDS reviews the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE KDMF as part of the drug registration process and uses the information provided in the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE suppliers with KDMF on PharmaCompass.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CEP of the European Pharmacopoeia monograph is often referred to as a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE Certificate of Suitability (COS). The purpose of a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE to their clients by showing that a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CEP has been issued for it. The manufacturer submits a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CEP (COS) as part of the market authorization procedure, and it takes on the role of a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CEP holder for the record. Additionally, the data presented in the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE DMF.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE suppliers with CEP (COS) on PharmaCompass.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE written confirmation (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE WC) is an official document issued by a regulatory agency to a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE manufacturer, verifying that the manufacturing facility of a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE APIs or DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE finished pharmaceutical products to another nation, regulatory agencies frequently require a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE WC (written confirmation) as part of the regulatory process.
click here to find a list of DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE suppliers with NDC on PharmaCompass.
DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND 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 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE GMP manufacturer or DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE GMP API supplier for your needs.
A DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CoA (Certificate of Analysis) is a formal document that attests to DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE's compliance with DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE specifications and serves as a tool for batch-level quality control.
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE CoA mostly includes findings from lab analyses of a specific batch. For each DORZOLAMIDE HYDROCHLORIDE AND 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.
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE may be tested according to a variety of international standards, such as European Pharmacopoeia (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE EP), DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE USP).
