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DRUG PRODUCT COMPOSITIONS0
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1. (r)-3-hydroxy-alpha-((methylamino)methyl)benzenemethanol
2. Metaoxedrin
3. Metasympatol
4. Mezaton
5. Neo Synephrine
6. Neo-synephrine
7. Neosynephrine
8. Phenylephrine
9. Phenylephrine Tannate
10. Tannate, Phenylephrine
1. 61-76-7
2. Phenylephrine Hcl
3. Biomydrin
4. Nostril
5. (r)-phenylephrine Hydrochloride
6. L-phenylephrine Hydrochloride
7. (r)-(-)-phenylephrine Hydrochloride
8. Phenylephrine.hcl
9. Mydfrin
10. Metaoxedrine Chloride
11. Vazculep
12. Neo-synephrine
13. Adrianol
14. Neophryn
15. Prefrin
16. Rhinall
17. Alcon Efrin
18. (-)-phenylephrine Hydrochloride
19. Nci-c55641
20. Efricel
21. Isopto Frin
22. Prefrin Liquifilm
23. (r)-3-(1-hydroxy-2-(methylamino)ethyl)phenol Hydrochloride
24. 3-[(1r)-1-hydroxy-2-(methylamino)ethyl]phenol;hydrochloride
25. Afrin 4 Hour Nasal Spray
26. Nsc-757273
27. 04ja59tnsj
28. Phenylephrine (hydrochloride)
29. Mls000069696
30. Ncgc00024257-04
31. Neosympatol
32. Synethenate
33. Almefrin
34. Consdrin
35. Emagrin
36. Fenilfar
37. Histabid
38. Idrianol
39. Lexatol
40. Oftalfrine
41. Phenistan
42. Pyristan
43. Smr000058497
44. Stanephrin
45. Sucraphen
46. Synasal
47. Fenox
48. Meta-sympatol
49. Alcon-efrin
50. (r)-(-)-1-(3-hydroxyphenyl)-2-methylaminoethanol Hydrochloride
51. [(2r)-2-hydroxy-2-(3-hydroxyphenyl)ethyl]-methylazanium;chloride
52. Dsstox_cid_1142
53. Op-isophrin
54. Dsstox_rid_75972
55. Neo-synesin 1
56. Dsstox_gsid_21142
57. Neooxedrine Chloride
58. 3-[(1r)-1-hydroxy-2-(methylamino)ethyl]phenol Hydrochloride
59. Consdrin Hydrochloride
60. Isophrin Hydrochloride
61. Vasosulf
62. Relief
63. Metaoxedrine Hydrochloride
64. Neosynephrine Hydrochloride
65. Sudafed Pe
66. Chebi:8094
67. Op-isophrin-z
68. Cas-61-76-7
69. Meta-synephrine Hydrochloride
70. Ccris 219
71. Levophenylephrine Hydrochloride
72. Phenylephrine Hydrochloride, L-
73. R-(-)-m-synephrine Hydrochloride
74. D-(-)-phenylephrine Hydrochloride
75. Einecs 200-517-3
76. Unii-04ja59tnsj
77. M-methylaminoethanolphenol Hydrochloride
78. Benzedrex Nasal Spray, Regular
79. Sr-01000075286
80. Mfcd00012605
81. Phenylephrine Hydrochloride [usp:jan]
82. Vicks Sinex Vapospray
83. Neo-synephrine (tn)
84. L-1-(m-hydroxyphenyl)-2-methyl-aminoethanol Hydrochloride
85. Vicks Sinex Nasal Spray
86. 1-m-hydroxy-alpha-(methylaminomethyl)benzyl Alcohol Hydrochloride
87. Opera_id_1786
88. (-)-m-hydroxy-alpha-((methylamino)methyl)benzyl Alcohol Hydrochloride
89. (r)-3-hydroxy-alpha-((methylamino)methyl)benzenemethanol Hydrochloride
90. (-)-alpha-hydroxy-beta-(methylamino)ethyl-alpha-(3-hydroxybenzene) Hydrochloride
91. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride, (-)-
92. Ec 200-517-3
93. Schembl24654
94. Mls006012005
95. Spectrum1500483
96. Phenylephrine Hydrochloride,(s)
97. Chembl1200339
98. Dtxsid3021142
99. L(-)-phenylephrine Hydrochloride
100. Hms1920h08
101. Pharmakon1600-01500483
102. Bcp23410
103. Hy-b0471
104. Tox21_110897
105. Tox21_201261
106. Tox21_302846
107. Tox21_500920
108. Ccg-39113
109. Nsc757273
110. S2569
111. Akos022190146
112. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride (r)-
113. Benzyl Alcohol, M-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride, (-)-
114. Tox21_110897_1
115. Lp00920
116. Nsc 757273
117. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride, (alphar)-
118. Phenylephrine Hydrochloride (jp17/usp)
119. Phenylephrine Hydrochloride [mi]
120. Ncgc00024257-08
121. Ncgc00094231-01
122. Ncgc00256496-01
123. Ncgc00258813-01
124. Ncgc00261605-01
125. Phenylephrine Hydrochloride [jan]
126. Bp166231
127. Bcp0726000237
128. Phenylephrine Hydrochloride [mart.]
129. Phenylephrine Hydrochloride [vandf]
130. Phenylephrine Hydrochloride [usp-rs]
131. Phenylephrine Hydrochloride [who-dd]
132. (r)-(-)-phenylephrine Hydrochloride, Powder
133. Eu-0100920
134. P0398
135. Sw219446-1
136. Vu0239753-6
137. D00511
138. D70603
139. P 6126
140. Phenylephrine Hydrochloride [orange Book]
141. A833410
142. Phenylephrine Hydrochloride [ep Monograph]
143. Phenylephrine Hydrochloride [usp Monograph]
144. Omidria Component Phenylephrine Hydrochloride
145. Q-201561
146. Sr-01000075286-1
147. Phenylephrine Hydrochloride Component Of Omidria
148. Prefrin-a Component Phenylephrine Hydrochloride
149. Q27107758
150. (r)-(-)-phenylephrine Hydrochloride, Analytical Standard
151. Cyclomydril Component Phenylephrine Hydrochloride
152. Phenergan Vc Component Phenylephrine Hydrochloride
153. Phenylephrine Hydrochloride Component Of Prefrin-a
154. Pherazine Vc Component Phenylephrine Hydrochloride
155. Phenylephrine Hydrochloride Component Of Cyclomydril
156. Phenylephrine Hydrochloride Component Of Phenergan Vc
157. Phenylephrine Hydrochloride Component Of Pherazine Vc
158. Promethazine Vc Component Phenylephrine Hydrochloride
159. Phenylephrine Hydrochloride Component Of Promethazine Vc
160. (r)-(-)-phenylephrine Hydrochloride, Tested According To Ph.eur.
161. Advil Congestion Relief Component Phenylephrine Hydrochloride
162. Benzenemethanol, 3-hydroxy-a-[(methylamino)methyl]-, Hydrochloride,(ar)-
163. Phenylephrine Hydrochloride Component Of Advil Congestion Relief
164. Phenylephrine Hydrochloride, British Pharmacopoeia (bp) Reference Standard
165. Phenylephrine Hydrochloride, European Pharmacopoeia (ep) Reference Standard
166. (-)-m-hydroxy-.alpha.-((methylamino)methyl)benzyl Alcohol Hydrochloride
167. Benzenemethanol, 3-hydroxy-.alpha.-((methylamino)methyl)-, Hydrochloride (r)-
168. Benzenemethanol, 3-hydroxy-alpha-((methylamino)methyl)-, Hydrochloride (1:1), (alphar)-
169. Phenylephrine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
170. Phenylephrine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
171. Phenylephrine Hydrochloride For Peak Identification, European Pharmacopoeia (ep) Reference Standard
172. R-(-)-phenylephrine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
| Molecular Weight | 203.66 g/mol |
|---|---|
| Molecular Formula | C9H14ClNO2 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 3 |
| Exact Mass | 203.0713064 g/mol |
| Monoisotopic Mass | 203.0713064 g/mol |
| Topological Polar Surface Area | 52.5 Ų |
| Heavy Atom Count | 13 |
| Formal Charge | 0 |
| Complexity | 130 |
| 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 2 | |
|---|---|
| Drug Name | Phenylephrine hydrochloride |
| Drug Label | NEO-SYNEPHRINE hydrochloride, brand of phenylephrine hydrochloride injectino, is a vasoconstrictor and pressor drug chemically related to epinephrine and ephedrine. NEO-SYNEPHRINE hydrochloride is a synthetic sympathomimetic agent in sterile form f... |
| Active Ingredient | Phenylephrine hydrochloride |
| Dosage Form | Solution/drops; Solution |
| Route | Ophthalmic; Iv (infusion) |
| Strength | 10mg/ml (10mg/ml); 10%; 2.5% |
| Market Status | Prescription |
| Company | West Ward Pharm; Paragon Bioteck |
| 2 of 2 | |
|---|---|
| Drug Name | Phenylephrine hydrochloride |
| Drug Label | NEO-SYNEPHRINE hydrochloride, brand of phenylephrine hydrochloride injectino, is a vasoconstrictor and pressor drug chemically related to epinephrine and ephedrine. NEO-SYNEPHRINE hydrochloride is a synthetic sympathomimetic agent in sterile form f... |
| Active Ingredient | Phenylephrine hydrochloride |
| Dosage Form | Solution/drops; Solution |
| Route | Ophthalmic; Iv (infusion) |
| Strength | 10mg/ml (10mg/ml); 10%; 2.5% |
| Market Status | Prescription |
| Company | West Ward Pharm; Paragon Bioteck |
Mydriatics
Agents that dilate the pupil. They may be either sympathomimetics or parasympatholytics. (See all compounds classified as Mydriatics.)
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.)
Vasoconstrictor Agents
Drugs used to cause constriction of the blood vessels. (See all compounds classified as Vasoconstrictor Agents.)
Adrenergic alpha-1 Receptor Agonists
Compounds that bind to and activate ADRENERGIC ALPHA-1 RECEPTORS. (See all compounds classified as Adrenergic alpha-1 Receptor Agonists.)
Cardiotonic Agents
Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE). (See all compounds classified as Cardiotonic Agents.)
API SUPPLIERS
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-18
Pay. Date : 2015-04-23
DMF Number : 28754
Submission : 2014-10-15
Status : Active
Type : II
Certificate Number : R1-CEP 2006-231 - Rev 01
Issue Date : 2016-10-20
Type : Chemical
Substance Number : 632
Status : Valid
Date of Issue : 2018-07-01
Valid Till : 2020-06-11
Written Confirmation Number : ZJI80030
Address of the Firm :
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Jai Radhe Sales is your partner for all your sourcing needs.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-05-29
Pay. Date : 2015-05-15
DMF Number : 18788
Submission : 2005-09-20
Status : Active
Type : II
Certificate Number : R0-CEP 2018-142 - Rev 02
Issue Date : 2021-09-13
Type : Chemical
Substance Number : 1035
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0093
Address of the Firm :
NDC Package Code : 57218-710
Start Marketing Date : 2007-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2014-02-18
Registration Number : 20080228-88-D-11-05(1)
Manufacturer Name : Malladi Drug & Pharmaceuticals Ltd
Manufacturer Address : 7B&7C, SIPCOT Industrial complex, Ranipet-632 403, Vellore District, India.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Nortec Quimica is the largest API manufacturer in Latin America.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
Details:
The Company intends to use the net proceeds for the commercialization activities for Mydcombi, the first and only FDA-approved fixed dose combination ophthalmic spray for pupil dilation.
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Brand Name: Mydcombi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Chardan Healthcare
Deal Size: $1.3 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 25, 2024
Lead Product(s) : Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Chardan Healthcare
Deal Size : $1.3 million
Deal Type : Public Offering
Eyenovia, Inc. Announces Pricing of $1.3 Million Registered Direct Offering
Details : The Company intends to use the net proceeds for the commercialization activities for Mydcombi, the first and only FDA-approved fixed dose combination ophthalmic spray for pupil dilation.
Brand Name : Mydcombi
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 25, 2024
Details:
Mydcombi is FDA approved, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Brand Name: Mydcombi
Study Phase: Phase IVProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2024
Lead Product(s) : Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Eyenovia Provides Update on Mydcombi™ and Clobetasol Propionate Ophthalmic Suspension
Details : Mydcombi is FDA approved, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Brand Name : Mydcombi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 25, 2024
Details:
Mydcombi is Eyenovia's USFDA approved, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Lead Product(s): Phenylephrine Hydrochloride,Tropicamide
Therapeutic Area: Ophthalmology Brand Name: Mydcombi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 08, 2023
Lead Product(s) : Phenylephrine Hydrochloride,Tropicamide
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Eyenovia Announces FDA Approval of Mydcombi™, the First Ophthalmic Spray for Mydriasis, Which Al...
Details : Mydcombi is Eyenovia's USFDA approved, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Brand Name : Mydcombi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 08, 2023
Details:
Under the terms of the Agreement, the royalty rate applicable to U.S. net sales of OMIDRIA (phenylephrine) decreased from 50 percent to 30 percent of U.S. net sales following achievement of the Milestone Event.
Lead Product(s): Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area: Ophthalmology Brand Name: Omidria
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Rayner
Deal Size: $1,326 million Upfront Cash: $126.0 million
Deal Type: Divestment February 06, 2023
Lead Product(s) : Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area : Ophthalmology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Rayner
Deal Size : $1,326 million
Deal Type : Divestment
Omeros Corporation Receives $200 Million Milestone Payment from Rayner Surgical
Details : Under the terms of the Agreement, the royalty rate applicable to U.S. net sales of OMIDRIA (phenylephrine) decreased from 50 percent to 30 percent of U.S. net sales following achievement of the Milestone Event.
Brand Name : Omidria
Molecule Type : Small molecule
Upfront Cash : $126.0 million
February 06, 2023
Details:
Mydcombi is Eyenovia's investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Brand Name: Mydcombi
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 12, 2023
Lead Product(s) : Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Eyenovia Reveals Positive Evidence That Optejet® Delivery Technology Decreased Inflammation From ...
Details : Mydcombi is Eyenovia's investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Brand Name : Mydcombi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 12, 2023
Details:
Mydcombi is Eyenovia's investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Brand Name: Mydcombi
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Lead Product(s) : Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi™ for In-Office Pupil Dila...
Details : Mydcombi is Eyenovia's investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation).
Brand Name : Mydcombi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 13, 2022
Details:
The financing is intended to support manufacturing in anticipation of a MydCombi (tropicamide) launch and clinical supply for ongoing programs. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis and myopia progression.
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Brand Name: Mydcombi
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Avenue Venture Opportunities Fund
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing November 29, 2022
Lead Product(s) : Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Avenue Venture Opportunities Fund
Deal Size : Undisclosed
Deal Type : Financing
Eyenovia Announces $15 Million Credit Facility with Avenue Venture Debt Fund
Details : The financing is intended to support manufacturing in anticipation of a MydCombi (tropicamide) launch and clinical supply for ongoing programs. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis and myopia...
Brand Name : Mydcombi
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 29, 2022
Details:
Under the Royalty Purchase Agreement, DRI is entitled to royalties on net sales of OMIDRIA (having phenylephrine) received between September 1, 2022 and December 31, 2030, subject to annual caps.
Lead Product(s): Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area: Neurology Brand Name: Omidria
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: DRI Healthcare Acquisitions
Deal Size: $188.4 million Upfront Cash: Undisclosed
Deal Type: Agreement October 03, 2022
Lead Product(s) : Phenylephrine Hydrochloride,Ketorolac Trometamol
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : DRI Healthcare Acquisitions
Deal Size : $188.4 million
Deal Type : Agreement
Omeros Corporation Announces Royalty Monetization Transaction with DRI Healthcare Trust
Details : Under the Royalty Purchase Agreement, DRI is entitled to royalties on net sales of OMIDRIA (having phenylephrine) received between September 1, 2022 and December 31, 2030, subject to annual caps.
Brand Name : Omidria
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 03, 2022
Details:
Under terms of the agreement, Dr Reddy’s purchased the Biorphen® (phenylephrine hydrochloride), Rezipres®, and Cysteine Hydrochloride products. Dr Reddy’s will immediately take ownership of Eton’s rights and interests in the products.
Lead Product(s): Phenylephrine Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Biorphen
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Dr. Reddy\'s Laboratories
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition June 24, 2022
Lead Product(s) : Phenylephrine Hydrochloride
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Dr. Reddy\'s Laboratories
Deal Size : $50.0 million
Deal Type : Acquisition
Eton Pharmaceuticals Announces Sale of Hospital Products
Details : Under terms of the agreement, Dr Reddy’s purchased the Biorphen® (phenylephrine hydrochloride), Rezipres®, and Cysteine Hydrochloride products. Dr Reddy’s will immediately take ownership of Eton’s rights and interests in the products.
Brand Name : Biorphen
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 24, 2022
Details:
MydCombi™ has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery.
Lead Product(s): Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area: Ophthalmology Brand Name: MydCombi
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2022
Lead Product(s) : Tropicamide,Phenylephrine Hydrochloride
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Eyenovia Concludes Type A Meeting with FDA Related to MydCombi™ NDA Resubmission
Details : MydCombi™ has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery.
Brand Name : MydCombi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 08, 2022
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DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0....DOSAGE - SOLUTION;INTRAVENOUS - 0.5MG/5ML (0.1MG/ML)
USFDA APPLICATION NUMBER - 203826
DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML)
USFDA APPLICATION NUMBER - 203826
DOSAGE - SOLUTION;INTRAVENOUS - 10MG/ML (10MG...DOSAGE - SOLUTION;INTRAVENOUS - 10MG/ML (10MG/ML)
USFDA APPLICATION NUMBER - 203826
DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1...DOSAGE - SOLUTION;INTRAVENOUS - 1MG/10ML (0.1MG/ML)
USFDA APPLICATION NUMBER - 203826
DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10M...DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML)
USFDA APPLICATION NUMBER - 203826
DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/10ML (10MG/ML)
USFDA APPLICATION NUMBER - 204300
DOSAGE - SOLUTION;INTRAVENOUS - 10MG/ML (10MG...DOSAGE - SOLUTION;INTRAVENOUS - 10MG/ML (10MG/ML)
USFDA APPLICATION NUMBER - 204300
DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10M...DOSAGE - SOLUTION;INTRAVENOUS - 50MG/5ML (10MG/ML)
USFDA APPLICATION NUMBER - 204300
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 10%
USFDA APPLICATION NUMBER - 207926
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 2.5%
USFDA APPLICATION NUMBER - 207926
DOSAGE - TABLET;ORAL - 4MG;200MG;10MG
USFDA APPLICATION NUMBER - 22113
DOSAGE - TABLET;ORAL - 200MG;10MG
USFDA APPLICATION NUMBER - 22565
DOSAGE - SYRUP;ORAL - 5MG/5ML;6.25MG/5ML
USFDA APPLICATION NUMBER - 88761
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ABOUT THIS PAGE
A Phenylephrine.HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylephrine.HCl, including repackagers and relabelers. The FDA regulates Phenylephrine.HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylephrine.HCl 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 Phenylephrine.HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenylephrine.HCl supplier is an individual or a company that provides Phenylephrine.HCl active pharmaceutical ingredient (API) or Phenylephrine.HCl finished formulations upon request. The Phenylephrine.HCl suppliers may include Phenylephrine.HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Phenylephrine.HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenylephrine.HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylephrine.HCl active pharmaceutical ingredient (API) in detail. Different forms of Phenylephrine.HCl DMFs exist exist since differing nations have different regulations, such as Phenylephrine.HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenylephrine.HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylephrine.HCl USDMF includes data on Phenylephrine.HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylephrine.HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenylephrine.HCl 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 Phenylephrine.HCl Drug Master File in Japan (Phenylephrine.HCl JDMF) empowers Phenylephrine.HCl 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 Phenylephrine.HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Phenylephrine.HCl 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 Phenylephrine.HCl 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 Phenylephrine.HCl Drug Master File in Korea (Phenylephrine.HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Phenylephrine.HCl. The MFDS reviews the Phenylephrine.HCl KDMF as part of the drug registration process and uses the information provided in the Phenylephrine.HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Phenylephrine.HCl 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 Phenylephrine.HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Phenylephrine.HCl suppliers with KDMF on PharmaCompass.
A Phenylephrine.HCl CEP of the European Pharmacopoeia monograph is often referred to as a Phenylephrine.HCl Certificate of Suitability (COS). The purpose of a Phenylephrine.HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phenylephrine.HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phenylephrine.HCl to their clients by showing that a Phenylephrine.HCl CEP has been issued for it. The manufacturer submits a Phenylephrine.HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phenylephrine.HCl CEP holder for the record. Additionally, the data presented in the Phenylephrine.HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phenylephrine.HCl DMF.
A Phenylephrine.HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenylephrine.HCl 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 Phenylephrine.HCl suppliers with CEP (COS) on PharmaCompass.
A Phenylephrine.HCl written confirmation (Phenylephrine.HCl WC) is an official document issued by a regulatory agency to a Phenylephrine.HCl manufacturer, verifying that the manufacturing facility of a Phenylephrine.HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Phenylephrine.HCl APIs or Phenylephrine.HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Phenylephrine.HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Phenylephrine.HCl 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 Phenylephrine.HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Phenylephrine.HCl 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 Phenylephrine.HCl 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 Phenylephrine.HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phenylephrine.HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Phenylephrine.HCl suppliers with NDC on PharmaCompass.
Phenylephrine.HCl 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 Phenylephrine.HCl 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 Phenylephrine.HCl GMP manufacturer or Phenylephrine.HCl GMP API supplier for your needs.
A Phenylephrine.HCl CoA (Certificate of Analysis) is a formal document that attests to Phenylephrine.HCl's compliance with Phenylephrine.HCl specifications and serves as a tool for batch-level quality control.
Phenylephrine.HCl CoA mostly includes findings from lab analyses of a specific batch. For each Phenylephrine.HCl 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.
Phenylephrine.HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Phenylephrine.HCl EP), Phenylephrine.HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phenylephrine.HCl USP).
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