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1. Aleve
2. Anaprox
3. Methoxypropiocin
4. Naprosin
5. Naprosyn
6. Naproxen
7. Naproxenate, Sodium
8. Proxen
9. Sodium Naproxenate
10. Sodium, Naproxen
11. Synflex
1. 26159-34-2
2. Naprelan
3. Anaprox
4. Naproxen Sodium Salt
5. Miranax
6. (-)-naproxen Sodium
7. Aleve
8. Naproxen (sodium)
9. Naprium
10. Naprux
11. Proxen
12. Sodium (s)-2-(6-methoxynaphthalen-2-yl)propanoate
13. Bayh6689
14. Apo-napro-na
15. (s)-naproxen Sodium Salt
16. Sodium Naproxen
17. Rs-3650
18. Naproxen Sodium Anhydrous
19. Mls000069555
20. 9tn87s3a3c
21. Chebi:7477
22. (-)-sodium (s)-6-methoxy-alpha-methyl-2-naphthaleneacetate
23. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, Sodium Salt, (s)-
24. Bay117031
25. Sodium;(2s)-2-(6-methoxynaphthalen-2-yl)propanoate
26. Bay-117031
27. Ncgc00017097-01
28. Anapran
29. Anaprotab
30. Aprowell
31. Floginex
32. Flogogin
33. Floneks
34. Floxalin
35. Gibinap
36. Gibixen
37. Karoksen
38. Leniartril
39. Monarit
40. Naprodil
41. Naprodol
42. Naprovite
43. Natrioxen
44. Pactens
45. Primeral
46. Smr000058746
47. Sodimax
48. Synflex
49. Flogen
50. Kapnax
51. Opraks
52. Tandax
53. (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium Salt
54. Aprol
55. Nixal
56. Cas-26159-34-2
57. Causalon Pro
58. Naproxen Natrium
59. Naprux Gesic
60. Axer Alfa
61. Dsstox_cid_25576
62. Dsstox_rid_80973
63. Dsstox_gsid_45576
64. Sodium (2s)-2-(6-methoxy-2-naphthyl)propanoate
65. A-nox
66. Anaprox Ds
67. Naproxensodium
68. Sunprox
69. Flanax
70. Naproxen Sodium [usan]
71. Einecs 247-486-2
72. Mfcd00058507
73. Unm-0000306098
74. Rs 3650
75. Topcare All Day Pain Relief
76. Unii-9tn87s3a3c
77. Naproxen Sodium [usan:usp]
78. Bay H6689
79. Naproxen (aleve)
80. Sodium (-)-2-(6-methoxy-2-naphthyl)propionate
81. Anaprox (tn)
82. Naproxen Sodium,(s)
83. Naproxen Sodium (usp)
84. L-(-)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium Salt
85. Opera_id_1200
86. Lopac-m-1275
87. Schembl7361
88. Mls001076076
89. Mls001424214
90. Naproxen Sodium [vandf]
91. Chembl1200806
92. Dtxsid7045576
93. Naproxen Sodium [mart.]
94. Naproxen Sodium [usp-rs]
95. Naproxen Sodium [who-dd]
96. Naproxen Sodium Salt [mi]
97. Hms1570o04
98. Hms2052g05
99. Hms2230d08
100. Hms3262o06
101. Hms3269j19
102. Hms3413p03
103. Hms3884g04
104. Tox21_110774
105. Tox21_500792
106. Hy-15030a
107. Naproxen Sodium, 98.0-102.0%
108. Naproxen Sodium [ep Impurity]
109. Naproxen Sodium [orange Book]
110. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, Sodium Salt, (s)-
111. Akos015895696
112. Akos015994759
113. Naproxen Sodium [ep Monograph]
114. Naproxen Sodium [usp Impurity]
115. Tox21_110774_1
116. Bcp9000977
117. Ccg-101082
118. Ks-5141
119. Lp00792
120. Naproxen Sodium [usp Monograph]
121. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, Sodium Salt, L-(-)-
122. Aleve-d Component Naproxen Sodium
123. Ncgc00016166-01
124. Ncgc00016759-04
125. Ncgc00017097-02
126. Ncgc00094127-01
127. Ncgc00261477-01
128. Treximet Component Naproxen Sodium
129. Bcp0726000300
130. Naproxen Sodium Component Of Aleve-d
131. Eu-0100792
132. M3406
133. Naproxen Sodium Component Of Treximet
134. S1626
135. Sw197105-3
136. 59n342
137. Bim-0050769.0001
138. D00970
139. M 1275
140. Sodium (s)-2-(6-methoxy-2-naphthyl)propionate
141. A818221
142. Naproxen Sodium, Meets Usp Testing Specifications
143. Sodium(s)-2-(6-methoxynaphthalen-2-yl)propanoate
144. W-107195
145. Q27107504
146. (2s)-2-(6-methoxy(2-naphthyl))propanoic Acid Sodium Salt
147. (2s)-2-(6-methoxy-2-naphthyl)propanoic Acid Sodium Salt
148. (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium
149. Naproxen Sodium, United States Pharmacopeia (usp) Reference Standard
150. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, Sodium Salt, (.alpha.s)- (1:1)
151. Naproxen Sodium, Pharmaceutical Secondary Standard; Certified Reference Material
| Molecular Weight | 252.24 g/mol |
|---|---|
| Molecular Formula | C14H13NaO3 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 3 |
| Exact Mass | 252.07623855 g/mol |
| Monoisotopic Mass | 252.07623855 g/mol |
| Topological Polar Surface Area | 49.4 Ų |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 282 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 12 | |
|---|---|
| Drug Name | Aleve |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 200mg base |
| Market Status | Over the Counter |
| Company | Bayer |
| 2 of 12 | |
|---|---|
| Drug Name | Anaprox |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 250mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 3 of 12 | |
|---|---|
| Drug Name | Anaprox ds |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 4 of 12 | |
|---|---|
| Drug Name | Naprelan |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 750mg base; eq 500mg base; eq 375mg base |
| Market Status | Prescription |
| Company | Almatica Pharma |
| 5 of 12 | |
|---|---|
| Drug Name | Naprosyn |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen |
| Dosage Form | Tablet; Suspension |
| Route | Oral |
| Strength | 250mg; 375mg; 500mg; 25mg/ml |
| Market Status | Prescription |
| Company | Roche Palo |
| 6 of 12 | |
|---|---|
| Drug Name | Naproxen sodium |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release; Tablet; Capsule |
| Route | Oral |
| Strength | eq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base |
| Market Status | Over the Counter; Prescription |
| Company | Marksans Pharma; Actavis Labs Fl; Teva; Aurobindo Pharma; Banner Pharmacaps; Granules India; Hikma; Amneal Pharms Ny; Glenmark Generics; Perrigo; Contract Pharmacal; Ranbaxy Labs; Dr Reddys Labs |
| 7 of 12 | |
|---|---|
| Drug Name | Aleve |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 200mg base |
| Market Status | Over the Counter |
| Company | Bayer |
| 8 of 12 | |
|---|---|
| Drug Name | Anaprox |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 250mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 9 of 12 | |
|---|---|
| Drug Name | Anaprox ds |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | eq 500mg base |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 10 of 12 | |
|---|---|
| Drug Name | Naprelan |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 750mg base; eq 500mg base; eq 375mg base |
| Market Status | Prescription |
| Company | Almatica Pharma |
| 11 of 12 | |
|---|---|
| Drug Name | Naprosyn |
| Drug Label | Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl... |
| Active Ingredient | Naproxen |
| Dosage Form | Tablet; Suspension |
| Route | Oral |
| Strength | 250mg; 375mg; 500mg; 25mg/ml |
| Market Status | Prescription |
| Company | Roche Palo |
| 12 of 12 | |
|---|---|
| Drug Name | Naproxen sodium |
| Drug Label | NAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r... |
| Active Ingredient | Naproxen sodium |
| Dosage Form | Tablet, extended release; Tablet; Capsule |
| Route | Oral |
| Strength | eq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base |
| Market Status | Over the Counter; Prescription |
| Company | Marksans Pharma; Actavis Labs Fl; Teva; Aurobindo Pharma; Banner Pharmacaps; Granules India; Hikma; Amneal Pharms Ny; Glenmark Generics; Perrigo; Contract Pharmacal; Ranbaxy Labs; Dr Reddys Labs |
Anti-Inflammatory Agents, Non-Steroidal
Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)
Cyclooxygenase Inhibitors
Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)
Gout Suppressants
Agents that increase uric acid excretion by the kidney (URICOSURIC AGENTS), decrease uric acid production (antihyperuricemics), or alleviate the pain and inflammation of acute attacks of gout. (See all compounds classified as Gout Suppressants.)
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-26
Pay. Date : 2015-03-19
DMF Number : 3208
Submission : 1978-05-25
Status : Active
Type : II
Certificate Number : R1-CEP 2008-110 - Rev 01
Issue Date : 2015-06-10
Type : Chemical
Substance Number : 1702
Status : Valid
NDC Package Code : 30007-815
Start Marketing Date : 2012-02-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : SK Chemical Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 20140318-143-I-360-09(3)
Manufacturer Name : Industrialas Quimicas Falcon de Mexico, SA De CV
Manufacturer Address : Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico
| Available Reg Filing : BR, RU |
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-10
Pay. Date : 2015-05-28
DMF Number : 8746
Submission : 1990-09-18
Status : Active
Type : II
Certificate Number : R1-CEP 2007-047 - Rev 05
Issue Date : 2022-03-24
Type : Chemical
Substance Number : 1702
Status : Valid
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-16
DMF Number : 12342
Submission : 1997-01-28
Status : Active
Type : II
Certificate Number : R1-CEP 2008-068 - Rev 03
Issue Date : 2019-06-21
Type : Chemical
Substance Number : 1702
Status : Valid
NDC Package Code : 30007-815
Start Marketing Date : 2012-02-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : SK Chemical Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 20140318-143-I-360-09(3)
Manufacturer Name : Industrialas Quimicas Falcon de Mexico, SA De CV
Manufacturer Address : Km. 4.5, Carretera Federal Cuernavaca-Cuautla Col. CIVAC CP 62578 Mpio. Jiutepec, Morelos, Mexico
| Available Reg Filing : BR, RU |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37526
Submission : 2022-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8436
Submission : 1990-02-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12559
Submission : 1997-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16200
Submission : 2002-10-22
Status : Inactive
Type : II
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Average Price (USD/KGS) |
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Drugs in Development
Details:
Dr. Reddy’s OTC Naproxen Sodium Tablets USP, 220 mg is an over-the-counter nonsteroidal antiinflammatory drug (NSAID) for use as a pain reliever and fever reducer. It temporarily relieves minor aches and pains.
Lead Product(s): Naproxen Sodium
Therapeutic Area: Neurology Brand Name: Naproxen Sodium-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2021
Lead Product(s) : Naproxen Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Dr. Reddy’s Announces the Re-Launch of Over-The-Counter Naproxen Sodium Tablets USP, 220 mg, Sto...
Details : Dr. Reddy’s OTC Naproxen Sodium Tablets USP, 220 mg is an over-the-counter nonsteroidal antiinflammatory drug (NSAID) for use as a pain reliever and fever reducer. It temporarily relieves minor aches and pains.
Product Name : Naproxen Sodium-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
August 03, 2021
Details:
USFDA approved generic version of naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.
Lead Product(s): Naproxen Sodium
Therapeutic Area: Neurology Brand Name: Naproxen Sodium-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Lead Product(s) : Naproxen Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Strides receives USFDA approval for Naproxen Sodium OTC Softgel Capsules
Details : USFDA approved generic version of naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.
Product Name : Naproxen Sodium-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
August 18, 2022
Details:
Generic of Naproxen Sodium and Diphenhydramine HCl Tablets are approved for relief of occasional sleeplessness associated with minor aches and pains and to help you fall asleep and stay asleep.
Lead Product(s): Naproxen Sodium,Diphenhydramine Hydrochloride
Therapeutic Area: Neurology Brand Name: Aleve-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Lead Product(s) : Naproxen Sodium,Diphenhydramine Hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Receives FDA Approval for Naproxen Sodium/Diphenhydramine Tablets
Details : Generic of Naproxen Sodium and Diphenhydramine HCl Tablets are approved for relief of occasional sleeplessness associated with minor aches and pains and to help you fall asleep and stay asleep.
Product Name : Aleve-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
September 25, 2020
Details:
The agreement aims for the exclusive right to package, distribute, market and sell Suvexx, a patent protected, fixed dose combination of naproxen sodium and sumatriptan approved for the acute treatment of migraine attacks in adults, in all remaining E.U. countries.
Lead Product(s): Naproxen Sodium,Sumatriptan
Therapeutic Area: Neurology Brand Name: Suvexx
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Orion Corporation
Deal Size: $0.6 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 15, 2023
Lead Product(s) : Naproxen Sodium,Sumatriptan
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Orion Corporation
Deal Size : $0.6 million
Deal Type : Licensing Agreement
Searchlight Pharma Announces Suvexx® Launch in Europe, Along with Deal Expansion to all E.U. Mark...
Details : The agreement aims for the exclusive right to package, distribute, market and sell Suvexx, a patent protected, fixed dose combination of naproxen sodium and sumatriptan approved for the acute treatment of migraine attacks in adults, in all remaining E.U....
Product Name : Suvexx
Product Type : Small molecule
Upfront Cash : Undisclosed
August 15, 2023
Details:
Naproxen Sodium and Pseudoephedrine Hydrochloride Sustained Release Tablets (brand name, Pusen OK), in which the compound ingredient pseudoephedrine is in line with the cold symptom relief medicine recommended in the Catalog.
Lead Product(s): Naproxen Sodium,Pseudoephedrine Hydrochloride
Therapeutic Area: Infections and Infectious Diseases Brand Name: Pusen OK
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2022
Lead Product(s) : Naproxen Sodium,Pseudoephedrine Hydrochloride
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Naproxen Sodium and Pseudoephedrine Hydrochloride Sustained Release Tablets (brand name, Pusen OK), in which the compound ingredient pseudoephedrine is in line with the cold symptom relief medicine recommended in the Catalog.
Product Name : Pusen OK
Product Type : Small molecule
Upfront Cash : Not Applicable
December 15, 2022
Details:
Miravo Healthcare, has entered into an exclusive license and supply agreement with Orion Corporation for the exclusive right to package, distribute, market and sell Suvexx in Finland, Sweden, Denmark, Norway, Poland, Hungary, Latvia, Lithuania and Estonia.
Lead Product(s): Naproxen Sodium,Sumatriptan
Therapeutic Area: Neurology Brand Name: Suvexx
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Orion Corporation
Deal Size: Undisclosed Upfront Cash: $2.0 million
Deal Type: Partnership December 21, 2020
Lead Product(s) : Naproxen Sodium,Sumatriptan
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Orion Corporation
Deal Size : Undisclosed
Deal Type : Partnership
Miravo Healthcare Ireland Enters into Suvexx® License and Supply Agreement with Orion Corporation...
Details : Miravo Healthcare, has entered into an exclusive license and supply agreement with Orion Corporation for the exclusive right to package, distribute, market and sell Suvexx in Finland, Sweden, Denmark, Norway, Poland, Hungary, Latvia, Lithuania and Estoni...
Product Name : Suvexx
Product Type : Small molecule
Upfront Cash : $2.0 million
December 21, 2020
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18164
DOSAGE - TABLET;ORAL - EQ 500MG BASE
USFDA APPLICATION NUMBER - 18164
DOSAGE - TABLET;ORAL - 220MG
USFDA APPLICATION NUMBER - 20204
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE
USFDA APPLICATION NUMBER - 20353
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 5...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE
USFDA APPLICATION NUMBER - 20353
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 7...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE
USFDA APPLICATION NUMBER - 20353
DOSAGE - CAPSULE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 21920
DOSAGE - TABLET;ORAL - 500MG;EQ 85MG BASE
USFDA APPLICATION NUMBER - 21926
DOSAGE - TABLET;ORAL - 60MG;EQ 10MG BASE
USFDA APPLICATION NUMBER - 21926
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48
PharmaCompass offers a list of Naproxen Sodium 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 Naproxen Sodium manufacturer or Naproxen Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naproxen Sodium manufacturer or Naproxen Sodium supplier.
PharmaCompass also assists you with knowing the Naproxen Sodium API Price utilized in the formulation of products. Naproxen Sodium API Price is not always fixed or binding as the Naproxen Sodium Price is obtained through a variety of data sources. The Naproxen Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Naproxen Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naproxen Sodium, including repackagers and relabelers. The FDA regulates Naproxen Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naproxen Sodium 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 Naproxen Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naproxen Sodium supplier is an individual or a company that provides Naproxen Sodium active pharmaceutical ingredient (API) or Naproxen Sodium finished formulations upon request. The Naproxen Sodium suppliers may include Naproxen Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Naproxen Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naproxen Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Naproxen Sodium active pharmaceutical ingredient (API) in detail. Different forms of Naproxen Sodium DMFs exist exist since differing nations have different regulations, such as Naproxen Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naproxen Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Naproxen Sodium USDMF includes data on Naproxen Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naproxen Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naproxen Sodium suppliers with USDMF 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 Naproxen Sodium Drug Master File in Korea (Naproxen Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naproxen Sodium. The MFDS reviews the Naproxen Sodium KDMF as part of the drug registration process and uses the information provided in the Naproxen Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naproxen Sodium 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 Naproxen Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naproxen Sodium suppliers with KDMF on PharmaCompass.
A Naproxen Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Naproxen Sodium Certificate of Suitability (COS). The purpose of a Naproxen Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naproxen Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naproxen Sodium to their clients by showing that a Naproxen Sodium CEP has been issued for it. The manufacturer submits a Naproxen Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naproxen Sodium CEP holder for the record. Additionally, the data presented in the Naproxen Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naproxen Sodium DMF.
A Naproxen Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naproxen Sodium 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 Naproxen Sodium suppliers with CEP (COS) on PharmaCompass.
A Naproxen Sodium written confirmation (Naproxen Sodium WC) is an official document issued by a regulatory agency to a Naproxen Sodium manufacturer, verifying that the manufacturing facility of a Naproxen Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naproxen Sodium APIs or Naproxen Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Naproxen Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Naproxen Sodium 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 Naproxen Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naproxen Sodium 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 Naproxen Sodium 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 Naproxen Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naproxen Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naproxen Sodium suppliers with NDC on PharmaCompass.
Naproxen Sodium 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 Naproxen Sodium 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 Naproxen Sodium GMP manufacturer or Naproxen Sodium GMP API supplier for your needs.
A Naproxen Sodium CoA (Certificate of Analysis) is a formal document that attests to Naproxen Sodium's compliance with Naproxen Sodium specifications and serves as a tool for batch-level quality control.
Naproxen Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Naproxen Sodium 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.
Naproxen Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Naproxen Sodium EP), Naproxen Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naproxen Sodium USP).
