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1. Hydrochloride, Oxymetazoline
2. Oxymetazoline
1. 2315-02-8
2. Oxymetazoline Hcl
3. Ocuclear
4. Afrazine
5. Afrin Hydrochloride
6. Sch 9384
7. Rhofade
8. Oxymetazoline (hydrochloride)
9. Visine L.r.
10. Vicks Sinex
11. Nsc-757254
12. K89mj0s5vy
13. 6-tert-butyl-3-(4,5-dihydro-1h-imidazol-2-ylmethyl)-2,4-dimethylphenol;hydrochloride
14. Mls000038040
15. Chebi:7863
16. Agn-199201
17. Sch-9384
18. Smr000059324
19. 2-(4-t-butyl-2,6-dimethyl-3-hydroxybenzyl)-2-imidazolinium Chloride
20. 2,6-dimethyl-2-(4-tertiarybutyl-3-hydroxyphenyl)methylimidazoline Hydrochloride
21. 6-tert-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol Monohydrochloride
22. 6-tert-butyl-3-(4,5-dihydro-1h-imidazol-2-ylmethyl)-2,4-dimethylphenol Hydrochloride
23. Phenol, 3-((4,5-dihydro-1h-imidazol-2-yl)methyl)-6-(1,1-dimethylethyl)-2,4-dimethyl-, Monohydrochloride
24. 2-(3-hydroxy-2,6-dimethyl-4-tert-butylbenzyl)-2-imidazoline
25. Lliadine
26. Nasivin
27. Nasivine
28. Neonabel
29. Nostrilla
30. Nafrine Hydrochloride
31. 4-way Nasal Spray
32. Duration Nasal Spray
33. Oxymetazoline Chloride
34. Lliadin Mini Paediatric
35. Sr-01000002705
36. Neo-synephrine 12 Hour
37. Neo-synephrine 12 Hour Ntz
38. Sinex
39. Anefrin Nasal
40. Duration 12 Hour Nasal Spray
41. Benzedrex Nasal Spray 12 Hour
42. Dristan Long Lasting Nasal Mist
43. Sudafed Om
44. Ocuclear (tn)
45. Prestwick_373
46. Einecs 219-015-0
47. St. Joseph Nasal Spray For Children
48. Mfcd00058147
49. Rhfade (tn)
50. Upneeq
51. Opera_id_32
52. 2-(3-hydroxy-2,6-dimethyl-4-t-butylbenzyl)-2-imidazoline Hydrochloride
53. Unii-k89mj0s5vy
54. 3-[(4,5-dihydro-
55. Schembl41247
56. Mls002222207
57. Spectrum1500453
58. Oxymetazoline Hydrochloride,(s)
59. Chembl1200791
60. Hy-b0427a
61. Dtxsid80177729
62. Oximetazoline Hydrochloride
63. Hms1568n09
64. Hms1920d18
65. Pharmakon1600-01500453
66. Tox21_500903
67. Ccg-40216
68. Nsc757254
69. 6-t-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol Hydrochloride
70. Akos000280887
71. Oxymetazoline Hydrochloride (jan/usp)
72. Phenol, 6-t-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethyl-, Hydrochloride
73. Ks-5222
74. Lp00903
75. Nsc 757254
76. Oxymetazoline Hydrochloride [mi]
77. Ncgc00094218-01
78. Ncgc00094218-02
79. Ncgc00094218-03
80. Ncgc00094218-04
81. Ncgc00094218-05
82. Ncgc00261588-01
83. Oxymetazoline Hydrochloride [jan]
84. 2315-02-8 (hcl)
85. Oxymetazoline Hydrochloride [usan]
86. Oxymetazoline Hydrochloride [mart.]
87. Oxymetazoline Hydrochloride [vandf]
88. 4-(2-boc-amino-pyridin-4-yl)-benzoicacid
89. Oxymetazoline Hydrochloride [who-dd]
90. Oxymetazoline Hydrochloride, >=99%, Solid
91. Eu-0100903
92. Ft-0673462
93. O0520
94. Oxymetazoline Hydrochloride [usan:usp:jan]
95. Sw196632-3
96. D01022
97. D91882
98. O 2378
99. Oxymetazoline Hydrochloride, Analytical Standard
100. Oxymetazoline Hydrochloride [orange Book]
101. 315o028
102. A910982
103. Oxymetazoline Hydrochloride [ep Monograph]
104. Oxymetazoline Hydrochloride [usp Impurity]
105. Oxymetazoline Hydrochloride [usp Monograph]
106. Kovanaze Component Oxymetazoline Hydrochloride
107. Sr-01000002705-2
108. Sr-01000002705-4
109. Sr-01000002705-7
110. W-107424
111. Q27107602
112. Oxymetazoline Hydrochloride Component Of Kovanaze
113. Sinex Vapospray Moisturizing 12-hour Decongestant Ultrafine Mist
114. 2,6-dimethyl-4-tertiarybutyl-3-hydroxyphenyl)methylimidazoline Hydrochloride
115. 2-(4-tert-butyl-2,6-dimethyl-3-hydroxybenzyl)-2-imidazolinium Chloride
116. 6-tert-butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol Hydrochloride
117. Oxymetazoline Hydrochloride, European Pharmacopoeia (ep) Reference Standard
118. 1h-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethylphenol Hydrochloride
119. 2-(3-hydroxy-2,6-dimethyl-4-tert-butylbenzyl)-2-imidazoline Hydrochloride
120. 2-(4-tert-butyl-3-hydroxy-2,6-dimethylbenzyl)-4,5-dihydro-1h-imidazol-1-ium Chloride
121. 6-(tert-butyl)-3-((4,5-dihydro-1h-imidazol-2-yl)methyl)-2,4-dimethylphenol Hydrochloride
122. 6-tert-butyl-3-((4,5-dihydro-1h-imidazol-2-yl)methyl)-2,4-dimethylphenol Hydrochloride
123. Oxymetazoline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
124. Oxymetazoline Hydrochloride, United States Pharmacopeia (usp) Reference Standard
125. 3-[(4,5-dihydro-1h-imidazol-2-yl)methyl]-6-(1,1-dimethylethyl)-2,4-dimethyl-phenol Hydrochloride
Molecular Weight | 296.83 g/mol |
---|---|
Molecular Formula | C16H25ClN2O |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 3 |
Exact Mass | 296.1655411 g/mol |
Monoisotopic Mass | 296.1655411 g/mol |
Topological Polar Surface Area | 44.6 Ų |
Heavy Atom Count | 20 |
Formal Charge | 0 |
Complexity | 345 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Nasal Decongestants
Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)
Sympathomimetics
Drugs that mimic the effects of stimulating postganglionic adrenergic sympathetic nerves. Included here are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters. (See all compounds classified as Sympathomimetics.)
Adrenergic alpha-Agonists
Drugs that selectively bind to and activate alpha adrenergic receptors. (See all compounds classified as Adrenergic alpha-Agonists.)
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-18
Pay. Date : 2013-01-04
DMF Number : 22401
Submission : 2008-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4290
Submission : 1981-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2019-02-11
DMF Number : 8940
Submission : 1991-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4230
Submission : 1981-06-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-324 - Rev 03
Status : Valid
Issue Date : 2018-05-18
Type : Chemical
Substance Number : 943
Certificate Number : R1-CEP 2008-064 - Rev 02
Status : Valid
Issue Date : 2021-01-15
Type : Chemical
Substance Number : 943
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0097
Address of the Firm : Block No. 251/P, 252/P, 253 to 255, 256/P,258/P, 276/P, 277/P, 278/P, 279 To 282...
NDC Package Code : 42419-005
Start Marketing Date : 2008-12-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-482
Start Marketing Date : 2021-11-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 62991-3201
Start Marketing Date : 2024-02-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-3205
Start Marketing Date : 2013-06-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 69056-005
Start Marketing Date : 2024-08-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65724-4503
Start Marketing Date : 2010-03-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49452-4954
Start Marketing Date : 2000-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
About the Company : Chynops Pharma, a company certified with ISO 9001:2015, is situated in Ahmedabad, India. We specialize in exporting, supplying, and trading a wide range of products, including APIs...
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
About the Company : Nortec Química stands as the largest manufacturer of Active Pharmaceutical Ingredients (IFAs) in Latin America, embarking on its mission to ensure the availability of quality medi...
About the Company : CTX is one of the youngest and fastest-growing Indian API and Intermediate manufacturing companies doing business in over 70 countries. In these five years, all my thoughts and act...
About the Company : Globela has been at the forefront of innovation for nearly seventy years. From humble beginnings in 2006 as a small pharmaceutical company, Globela’s current portfolio of vertica...
About the Company : As an internationally renowned outsourcing partner, we offer products and tailor-made service packages that are seamlessly embedded in the value chain of our customers. Our pharmac...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info :
Registration Country : Ukraine
Brand Name : Rinazoline
Dosage Form : Nasal Drops
Dosage Strength : 0.5MG/ML
Packaging : 10ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Ukraine
Brand Name : Rinazoline
Dosage Form : Nasal Spray
Dosage Strength : 0.5MG/ML
Packaging : 15ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Sweden
Brand Name : Nezeril
Dosage Form : NASAL DROPS, SOLUTION IN SINGLE-DOSE CONTAINERS
Dosage Strength : 0.5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Nezeril
Dosage Form : NASAL SPRAY, SOLUTION
Dosage Strength : 0.5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Iliadin
Dosage Form : NASAL SPRAY, SOLUTION
Dosage Strength : 0.25 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Iliadin
Dosage Form : NASAL DROPS, SOLUTION
Dosage Strength : 0.1 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Brand Name : Nasivin Pur
Dosage Form : Metered Spray
Dosage Strength : 0.03%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Nasivin Pur dosing dropper
Dosage Form : Gtt Nas
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Oxidropz
Dosage Form : NÄSDROPPAR, LÖSNING I ENDOSBEHÅLLARE
Dosage Strength : 0,1 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Oxidropz
Dosage Form : NÄSDROPPAR, LÖSNING I ENDOSBEHÅLLARE
Dosage Strength : 0,25 MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Oxylin Liquifilm Sterile Ophthalmic Solution
Dosage Form : OPD
Dosage Strength : 5mg/ml
Packaging : 15X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Drixine 0.05% Adult
Dosage Form : NSS
Dosage Strength : 40mg
Packaging : 20X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Drixine 0.05% Adult
Dosage Form : NAS
Dosage Strength : 200mg
Packaging : 20X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Drixine 0.025% Paediatric
Dosage Form : NOD
Dosage Strength : 5mg/ml
Packaging : 1X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Dristan Long Lasting Vapour Nasal Spray (Squeeze spray bottle)
Dosage Form : NAS
Dosage Strength : 100mg
Packaging : 15X1mg/g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Dristan Long Lasting Vapour Nasal Spray (Metered Pump Spray)
Dosage Form : NAS
Dosage Strength : 40mg
Packaging : 15X1mg/g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Iliadin Nasal Spray 0.05%
Dosage Form : NAS
Dosage Strength : 15mg/30 ml
Packaging : 20X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : ZADIN 0,025% Nasal Spray
Dosage Form : NAS
Dosage Strength : 250mg
Packaging : 10X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : ZADIN 0,05% Nasal Spray
Dosage Form : NAS
Dosage Strength : 250mg
Packaging : 10X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Drinasal S
Dosage Form : SUS
Dosage Strength : 30mg/ml
Packaging : 50X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Nasal Solution
Dosage Strength : 0.05%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : Nasal Solution
Dosage Strength : 0.05%
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Spain
Brand Name : Nasolina
Dosage Form : Solution
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Solution
Dosage Strength : 0.5MG/ML
Brand Name : Nasolina
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Iran
Brand Name :
Dosage Form : Nasal Spray
Dosage Strength : 0.05%
Packaging : 15 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging : 15 ML
Regulatory Info :
Dosage : Nasal Spray
Dosage Strength : 0.05%
Brand Name :
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Turkey
Brand Name : BURUNACH
Dosage Form : NASAL DROPS/SPRAY
Dosage Strength : 0.01%
Packaging : 5 ML/BOTTLE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging : 5 ML/BOTTLE
Regulatory Info :
Dosage : NASAL DROPS/SPRAY
Dosage Strength : 0.01%
Brand Name : BURUNACH
Approval Date :
Application Number :
Registration Country : Turkey
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Oxymetazoline Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxymetazoline Hydrochloride, including repackagers and relabelers. The FDA regulates Oxymetazoline Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxymetazoline 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 Oxymetazoline Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxymetazoline Hydrochloride supplier is an individual or a company that provides Oxymetazoline Hydrochloride active pharmaceutical ingredient (API) or Oxymetazoline Hydrochloride finished formulations upon request. The Oxymetazoline Hydrochloride suppliers may include Oxymetazoline Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Oxymetazoline Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxymetazoline Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxymetazoline Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Oxymetazoline Hydrochloride DMFs exist exist since differing nations have different regulations, such as Oxymetazoline Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxymetazoline Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Oxymetazoline Hydrochloride USDMF includes data on Oxymetazoline Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxymetazoline Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxymetazoline 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 Oxymetazoline Hydrochloride Drug Master File in Japan (Oxymetazoline Hydrochloride JDMF) empowers Oxymetazoline 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 Oxymetazoline Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Oxymetazoline 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 Oxymetazoline Hydrochloride suppliers with JDMF on PharmaCompass.
A Oxymetazoline Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Oxymetazoline Hydrochloride Certificate of Suitability (COS). The purpose of a Oxymetazoline Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxymetazoline Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxymetazoline Hydrochloride to their clients by showing that a Oxymetazoline Hydrochloride CEP has been issued for it. The manufacturer submits a Oxymetazoline Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxymetazoline Hydrochloride CEP holder for the record. Additionally, the data presented in the Oxymetazoline Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxymetazoline Hydrochloride DMF.
A Oxymetazoline Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxymetazoline 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 Oxymetazoline Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Oxymetazoline Hydrochloride written confirmation (Oxymetazoline Hydrochloride WC) is an official document issued by a regulatory agency to a Oxymetazoline Hydrochloride manufacturer, verifying that the manufacturing facility of a Oxymetazoline Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxymetazoline Hydrochloride APIs or Oxymetazoline Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxymetazoline Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxymetazoline 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 Oxymetazoline Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxymetazoline 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 Oxymetazoline 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 Oxymetazoline Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxymetazoline Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxymetazoline Hydrochloride suppliers with NDC on PharmaCompass.
Oxymetazoline 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 Oxymetazoline 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 Oxymetazoline Hydrochloride GMP manufacturer or Oxymetazoline Hydrochloride GMP API supplier for your needs.
A Oxymetazoline Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Oxymetazoline Hydrochloride's compliance with Oxymetazoline Hydrochloride specifications and serves as a tool for batch-level quality control.
Oxymetazoline Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Oxymetazoline 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.
Oxymetazoline Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxymetazoline Hydrochloride EP), Oxymetazoline Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxymetazoline Hydrochloride USP).
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