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1. Antistrumin
2. Iodide, Potassium
3. Ioduro Potasico Rovi
4. Iosat
5. Jod Beta
6. Jodetten Henning
7. Jodgamma
8. Jodid
9. Jodid Dura
10. Jodid Hexal
11. Jodid Ratiopharm
12. Jodid Verla
13. Jodid-ratiopharm
14. Mono Jod
15. Mono-jod
16. Pima
17. Sski
18. Thyro Block
19. Thyro-block
20. Thyroprotect
1. 7681-11-0
2. Thyro-block
3. Pima
4. Kali Iodide
5. Potassium Iodide (ki)
6. Knollide
7. Thyroshield
8. Iosat
9. Kisol
10. Kalii Iodidum
11. Potassium;iodide
12. Asmofug E
13. Potassium Diiodide
14. Dipotassium Diiodide
15. Potassium Monoiodide
16. Potassiumiodide
17. Kaliumiodid
18. Thyrosafe
19. Potassium Iodide (k2i2)
20. Potassium Iodide (k(i2))
21. K1-n
22. Kali Iodatum
23. Potassium-iodide
24. Mfcd00011405
25. Nsc-77362
26. 1c4qk22f9j
27. Chebi:8346
28. Joptone
29. Potide
30. Potassium Iodide Solution
31. Iodure De Potassium
32. Tripotassium Triiodide
33. Caswell No. 694
34. Iodopotassium
35. Kalium Iodatum
36. Potassium Iodide [jan]
37. Iodine Solution, 0.1n (n/10)
38. Potassium Iodide (k3i3)
39. Hsdb 5040
40. Einecs 231-659-4
41. Nsc 77362
42. Epa Pesticide Chemical Code 075701
43. Unii-1c4qk22f9j
44. Potasium Iodide
45. Potassium Iodid
46. Potassium Iodide [usp:jan]
47. Ai3-52931
48. Ccris 8168
49. Potassium Salt Of Hydriodic Acid
50. Thyroblock (tn)
51. Potassium Iodide Ts
52. Gold Etchant, Standard
53. Iodine (as Potassium)
54. Potassium Iodide,(s)
55. Nesslers Reagent Solution
56. Potassium Iodide Usp/fcc
57. Potassium Iodide Acs Grade
58. Wln: Ka I
59. Ec 231-659-4
60. Potassium Iodide, Ultra Dry
61. Potassium Iodide, 99.5%
62. Chembl1141
63. Dsstox_cid_14836
64. Dsstox_rid_79208
65. Kali Iodatum [hpus]
66. Dsstox_gsid_34836
67. Iodine (as Potassium Iodide)
68. Potassium Iodide Neutral Acs
69. Potassium Iodide [mi]
70. Potassium Iodide, Acs Reagent
71. Potassium Iodide [fcc]
72. Potassium Iodide (jp17/usp)
73. Potassium Iodide [hsdb]
74. Potassium Iodide [inci]
75. Dtxsid7034836
76. Potassium Iodide [vandf]
77. Potassium Iodide [mart.]
78. Potassium Iodide, Lr, >=99%
79. Potassium Iodide [usp-rs]
80. Potassium Iodide [who-dd]
81. Potassium Iodide [who-ip]
82. Hms3651g04
83. Cs-b1801
84. K I (h2 O)2
85. Nsc77362
86. Potassium Iodide, Ar, >=99.8%
87. Tox21_301293
88. S1897
89. Kalii Iodidum [who-ip Latin]
90. Mercuric And Potassium Iodide Solution
91. Akos015833375
92. Potassium Iodide [orange Book]
93. Ccg-266323
94. Db06715
95. Iodine (as Potassium) [vandf]
96. Potassium Iodide [ep Monograph]
97. Potassium Iodide, Bioxtra, >=99.0%
98. Potassium Iodide [usp Monograph]
99. Ncgc00257542-01
100. Potassium Iodide Solution, 15 % (w/v)
101. Potassium Iodide, Reagentplus(r), 99%
102. Cas-7681-11-0
103. Potassium Iodide, Vetec(tm) Reagent Grade
104. Potassium Iodide, Acs Reagent, >=99.0%
105. Potassium Iodide, Plant Cell Culture Tested
106. Ft-0645116
107. P1721
108. Potassium Iodide, 99.999% (metals Basis)
109. Sw219147-1
110. Iodine (as Potassium Iodide) [vandf]
111. Potassium Iodide, Bioultra, >=99.5% (at)
112. Potassium Iodide, Tested According To Ph.eur.
113. Potassium Iodide, Trace Metals Grade 99.99%
114. C08219
115. D01016
116. Potassium Iodide, Saj First Grade, >=99.5%
117. Ab01274864-01
118. Ab01568251_01
119. Potassium Iodide, >=99.99% Trace Metals Basis
120. Potassium Iodide, Jis Special Grade, >=99.5%
121. Potassium Iodide, Purum P.a., >=99.0% (at)
122. Q121874
123. Potassium Iodide, Puriss. P.a., Acs Reagent, >=99.0% (at)
124. Potassium Iodide, Suitable For Oxidant Determination, >=99.5%
125. Potassium Iodide, Anhydrous, Beads, -10 Mesh, 99.998% Trace Metals Basis
126. Potassium Iodide, Puriss. P.a., Reag. Iso, Reag. Ph. Eur., >=99.5%
127. Potassium Iodide, United States Pharmacopeia (usp) Reference Standard
128. Potassium Iodide, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99%
129. Potassium Iodide, Anhydrous, Free-flowing, Redi-dri(tm), Reagentplus(r), 99%
130. Potassium Iodide, Pharmaceutical Secondary Standard; Certified Reference Material
131. Potassium Iodide, Puriss., Meets Analytical Specification Of Ph.??eur. Bp, Usp, 99.0-100.5% (calc. To The Dried Substance)
Molecular Weight | 166.0028 g/mol |
---|---|
Molecular Formula | IK |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 1 |
Rotatable Bond Count | 0 |
Exact Mass | 165.86818 g/mol |
Monoisotopic Mass | 165.86818 g/mol |
Topological Polar Surface Area | 0 Ų |
Heavy Atom Count | 2 |
Formal Charge | 0 |
Complexity | 2 |
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 |
1 of 6 | |
---|---|
Drug Name | Iosat |
PubMed Health | Potassium Iodide (By mouth) |
Drug Classes | Antithyroid Agent, Expectorant, Iodide Supplement, Radiation Emergency, Thyroid Blocking Agent |
Drug Label | Each white, round, cross-scoredthe name IOSAT stamped on one sidetablet contains 130 mg of potassium iodide.... |
Active Ingredient | Potassium iodide |
Dosage Form | Tablet |
Route | Oral |
Strength | 65mg; 130mg |
Market Status | Over the Counter |
Company | Anbex |
2 of 6 | |
---|---|
Drug Name | Thyrosafe |
Drug Label | Each milliliter (1 mL) of ThyroShield contains 65 mg of potassium iodide (USP) in a black raspberry-flavored solution. Inactive ingredients are: FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glyco... |
Active Ingredient | Potassium iodide |
Dosage Form | Tablet |
Route | Oral |
Strength | 65mg |
Market Status | Over the Counter |
Company | Recip |
3 of 6 | |
---|---|
Drug Name | Thyroshield |
Active Ingredient | Potassium iodide |
Dosage Form | Solution |
Route | Oral |
Strength | 65mg/ml |
Market Status | Over the Counter |
Company | Arco Pharms |
4 of 6 | |
---|---|
Drug Name | Iosat |
PubMed Health | Potassium Iodide (By mouth) |
Drug Classes | Antithyroid Agent, Expectorant, Iodide Supplement, Radiation Emergency, Thyroid Blocking Agent |
Drug Label | Each white, round, cross-scoredthe name IOSAT stamped on one sidetablet contains 130 mg of potassium iodide.... |
Active Ingredient | Potassium iodide |
Dosage Form | Tablet |
Route | Oral |
Strength | 65mg; 130mg |
Market Status | Over the Counter |
Company | Anbex |
5 of 6 | |
---|---|
Drug Name | Thyrosafe |
Drug Label | Each milliliter (1 mL) of ThyroShield contains 65 mg of potassium iodide (USP) in a black raspberry-flavored solution. Inactive ingredients are: FD&C Red #40 and Blue #1, methylparaben, natural and artificial black raspberry flavor, propylene glyco... |
Active Ingredient | Potassium iodide |
Dosage Form | Tablet |
Route | Oral |
Strength | 65mg |
Market Status | Over the Counter |
Company | Recip |
6 of 6 | |
---|---|
Drug Name | Thyroshield |
Active Ingredient | Potassium iodide |
Dosage Form | Solution |
Route | Oral |
Strength | 65mg/ml |
Market Status | Over the Counter |
Company | Arco Pharms |
Potassium iodide is indicated as a radiation protectant (thyroid gland) prior to and following oral administration or inhalation of radioactive isotopes of iodine or in radiation emergencies. /Included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
Potassium iodide is indicated in the treatment of hyperthyroidism. /Included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
Potassium iodide is used in the treatment of erythema nodosum. /NOT included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
Potassium iodide is used concurrently with an antithyroid agent to induce thyroid involution prior to thyroidectomy. /NOT included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
For more Therapeutic Uses (Complete) data for POTASSIUM IODIDE (12 total), please visit the HSDB record page.
VET: WARNING: Iodism may occur at therapeutic doses.
Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 475
Since some individuals are markedly sensitive to iodides, potassium iodide should be used with caution when initially administered. Patients at risk for iodine-induced adverse effects include those with hypocomplementemic vasculitis and those with goiter or autoimmune thyroid disease.
McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3125
... Potassium iodide should be used with extreme caution, if at all, in patients with tuberculosis and is contraindicated in the presents of acute bronchitis.
McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3125
Potassium iodide may cause salivary gland swelling or tenderness, burning of mouth or throat, metallic taste, soreness of teeth and gums, and unusual increase in salivation.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
For more Drug Warnings (Complete) data for POTASSIUM IODIDE (22 total), please visit the HSDB record page.
Potassium Iodide is oral antithyroid agent used in the prevention of radioactive iodine uptake into the thyroid gland during a nuclear radiation emergency. Potassium Iodide may be used as an adjunct to other antithyroid agents in the treatment of hyperthyroidism and thyrotoxicosis and preoperatively to induce thyroid involution.
It works in the thyroid gland. By inhibiting thyroid hormone synthesis and release, thyroid gland vascularity is reduced, thyroid gland tissue becomes firmer, thyroid cell size is reduced, follicular colloid reaccumulates, and bound iodine levels increase. As a protectant following radiation exposure, KI blocks the uptake of radioactive iodine isotopes by the thyroid gland thereby minimizing the risk of radiation-induced thyroid neoplasms.
R - Respiratory system
R05 - Cough and cold preparations
R05C - Expectorants, excl. combinations with cough suppressants
R05CA - Expectorants
R05CA02 - Potassium iodide
S - Sensory organs
S01 - Ophthalmologicals
S01X - Other ophthalmologicals
S01XA - Other ophthalmologicals
S01XA04 - Potassium iodide
V - Various
V03 - All other therapeutic products
V03A - All other therapeutic products
V03AB - Antidotes
V03AB21 - Potassium iodide
Although eliminated chiefly by the kidneys, it can also be found in saliva, tears, sweat, & milk. ... Some of retained iodine is stored in the thyroid & incorporated into thyroxine.
Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 475
The iodide ion is excreted in part by bronchi.
American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 48:00
Potassium iodide is distributed into /human/ breast milk ...
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
In hyperthyroid patients, potassium iodide produces rapid remission of symptoms by inhibiting the release of thyroid hormone into the circulation. The effects of potassium iodide on the thyroid gland include reduction of vascularity, a firming of the glandular tissue, shrinkage of the size of individual cells, reaccumulation of colloid in the follicles, and increases in bound iodine. These actions may facilitate thyroidectomy when the medication is given prior to surgery.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
When administered prior to and following administration of radioactive isotopes and in radiation emergencies involving the release of radioactive iodine, potassium iodide protects the thyroid gland by blocking the thyroidal uptake of radioactive isotopes of iodine.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
The mechanism of action of potassium iodide's antifungal activity against Sporothix schenckii has not been determined. Potassium iodide does not appear to increase monocyte or neutrophil killing of S. schenckii in in vitro studies. However, exposure of the yeast form of S. schenckii to various concentrations of iodine (iodine and potassium iodide solution) has resulted in rapid cell destruction.
McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3126
Potassium iodide is thought to act as an expectorant by increasing respiratory tract secretions and thereby decreasing the viscosity of mucous ...
McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3126
When potassium iodide is administered simultaneously with radiation exposure, the protectant effect is approximately 97%. Potassium iodide given 12 and 24 hours before exposure yields a 90% and 70% protectant effect, respectively. However, potassium iodide administered 1 and 3 hours after exposure results in an 85% and 50% protectant effect, respectively. Potassium iodide administered more than 6 hours after exposure is thought to have a negligible protectant effect.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32131
Submission : 2017-10-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36523
Submission : 2021-12-11
Status : Active
Type : IV
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-10
Pay. Date : 2013-08-30
DMF Number : 23615
Submission : 2010-03-09
Status : Active
Type : II
Certificate Number : R1-CEP 2007-337 - Rev 02
Issue Date : 2020-05-27
Type : Chemical
Substance Number : 186
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28693
Submission : 2014-09-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5780
Submission : 1985-04-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16050
Submission : 2002-07-09
Status : Inactive
Type : II
Date of Issue : 2020-11-12
Valid Till : 2023-11-06
Written Confirmation Number : WC-0298
Address of the Firm :
Date of Issue : 2020-11-12
Valid Till : 2023-11-06
Written Confirmation Number : WC-0298A1
Address of the Firm :
NDC Package Code : 70115-0005
Start Marketing Date : 2019-05-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5780
Submission : 1985-04-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36523
Submission : 2021-12-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16050
Submission : 2002-07-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-08-30
DMF Number : 23615
Submission : 2010-03-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32131
Submission : 2017-10-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28693
Submission : 2014-09-29
Status : Active
Type : IV
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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RLD : No
TE Code :
Brand Name : POTASSIUM IODIDE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 65MG/ML
Approval Date : 2016-03-24
Application Number : 206211
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : IOSAT
Dosage Form : TABLET;ORAL
Dosage Strength : 130MG
Approval Date : 1982-10-14
Application Number : 18664
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : IOSAT
Dosage Form : TABLET;ORAL
Dosage Strength : 65MG
Approval Date : 2011-05-12
Application Number : 18664
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : THYROSHIELD
Dosage Form : SOLUTION;ORAL
Dosage Strength : 65MG/ML
Approval Date : 2005-01-12
Application Number : 77218
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : THYROSAFE
Dosage Form : TABLET;ORAL
Dosage Strength : 65MG
Approval Date : 2002-09-10
Application Number : 76350
RX/OTC/DISCN : OTC
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : THYRO-BLOCK
Dosage Form : TABLET;ORAL
Dosage Strength : 130MG
Approval Date : 1982-01-01
Application Number : 18307
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : POTASSIUM IODIDE
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1GM/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-02-19
Application Number : 18551
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Ukraine
Brand Name : Iodid - Farmak
Dosage Form : Tablet
Dosage Strength : 100MKG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Ukraine
Brand Name : Iodid - Farmak
Dosage Form : Tablet
Dosage Strength : 200MKG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Italy
CALCIUM CHLORIDE; Potassium Iodide; Sodium Iodide
Brand Name : Polijodurato
Dosage Form :
Dosage Strength : Coll 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Potassium iodide GL Pharma
Dosage Form : TABLET
Dosage Strength : 65 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : Generic
Registration Country : Turkey
Brand Name : Pregniofol Iodide
Dosage Form : TABLET
Dosage Strength :
Packaging : 90 Tablets
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Sweden
Brand Name : Potassium iodide RPH Pharma
Dosage Form : TABLET
Dosage Strength : 65 MG
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 : Spain
Brand Name : 50 Yoduk 200Mcg Tablets
Dosage Form : Tablet
Dosage Strength : 2 Mg/Tablet
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Spain
Brand Name : 50 Yodafar 200Mcg Tablets
Dosage Form : Tablet
Dosage Strength : 2 Mg/Tablet
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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A Potassium Iodide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Iodide, including repackagers and relabelers. The FDA regulates Potassium Iodide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Iodide 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 Potassium Iodide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Iodide supplier is an individual or a company that provides Potassium Iodide active pharmaceutical ingredient (API) or Potassium Iodide finished formulations upon request. The Potassium Iodide suppliers may include Potassium Iodide API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Iodide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Iodide DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Iodide active pharmaceutical ingredient (API) in detail. Different forms of Potassium Iodide DMFs exist exist since differing nations have different regulations, such as Potassium Iodide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Iodide DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Iodide USDMF includes data on Potassium Iodide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Iodide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Iodide 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 Potassium Iodide Drug Master File in Japan (Potassium Iodide JDMF) empowers Potassium Iodide 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 Potassium Iodide JDMF during the approval evaluation for pharmaceutical products. At the time of Potassium Iodide 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 Potassium Iodide suppliers with JDMF on PharmaCompass.
A Potassium Iodide CEP of the European Pharmacopoeia monograph is often referred to as a Potassium Iodide Certificate of Suitability (COS). The purpose of a Potassium Iodide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Potassium Iodide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Potassium Iodide to their clients by showing that a Potassium Iodide CEP has been issued for it. The manufacturer submits a Potassium Iodide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Potassium Iodide CEP holder for the record. Additionally, the data presented in the Potassium Iodide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Potassium Iodide DMF.
A Potassium Iodide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Potassium Iodide 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 Potassium Iodide suppliers with CEP (COS) on PharmaCompass.
A Potassium Iodide written confirmation (Potassium Iodide WC) is an official document issued by a regulatory agency to a Potassium Iodide manufacturer, verifying that the manufacturing facility of a Potassium Iodide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Potassium Iodide APIs or Potassium Iodide finished pharmaceutical products to another nation, regulatory agencies frequently require a Potassium Iodide WC (written confirmation) as part of the regulatory process.
click here to find a list of Potassium Iodide 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 Potassium Iodide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Potassium Iodide 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 Potassium Iodide 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 Potassium Iodide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Potassium Iodide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Potassium Iodide suppliers with NDC on PharmaCompass.
Potassium Iodide 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 Potassium Iodide 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 Potassium Iodide GMP manufacturer or Potassium Iodide GMP API supplier for your needs.
A Potassium Iodide CoA (Certificate of Analysis) is a formal document that attests to Potassium Iodide's compliance with Potassium Iodide specifications and serves as a tool for batch-level quality control.
Potassium Iodide CoA mostly includes findings from lab analyses of a specific batch. For each Potassium Iodide 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.
Potassium Iodide may be tested according to a variety of international standards, such as European Pharmacopoeia (Potassium Iodide EP), Potassium Iodide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Potassium Iodide USP).
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