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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 2015-075 - Rev 00
Issue Date : 2021-03-25
Type : Chemical
Substance Number : 632
Status : Valid
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 : R1-CEP 2003-179 - Rev 04
Issue Date : 2021-09-13
Type : Chemical
Substance Number : 632
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 : 2025-12-31
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.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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USDMF
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API / Semi finish form...
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Drugs in Development
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Regulatory Info :
Registration Country : Norway
Brand Name : Fenylefrin Abcur
Dosage Form : Injection fluid, resolution
Dosage Strength : 0.05 mg/ml
Packaging : Ampoule of glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Metaoxedrin Minims
Dosage Form : Eye drops, solution
Dosage Strength : 100 mg/ml
Packaging : Endo container 20 0.5ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Ukraine
Phenylephrine Hydrochloride; Dimetindene Maleate
Brand Name : Edem RINO
Dosage Form : Nasal Spray
Dosage Strength : 2.5MG/ML; 0.25MG/ML
Packaging : 10ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Regulatory Info :
Registration Country : Sweden
Brand Name : Phenylephrine Stragen
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 50 MICROGRAM / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Phenylephrine Unimedic
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 0.05 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Fenylefrin Unimedic
Dosage Form : Injection fluid, resolution
Dosage Strength : 0.05 mg/ml
Packaging : Ampoule of glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Generic
Registration Country : Turkey
Dexamethasone; Framycetin; Phenylephrine; Polymyxin B
Brand Name :
Dosage Form : NASAL SPRAY
Dosage Strength : 0.25MG; 10MG; 2.5MG; 10.000IU
Packaging : 15 Ml/Bottle
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Turkey
Acetaminophen/Paracetamol; Phenylephrine Hydrochloride; Pheniramine
Brand Name :
Dosage Form : SACHET
Dosage Strength : 650MG; 10MG; 20M G
Packaging : 7 Or 10 Sachets/Box
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Generic
Registration Country : Turkey
Acetaminophen/Paracetamol; Phenylephrine Hydrochloride; Pheniramine; Ascorbic Acid
Brand Name :
Dosage Form : SACHET
Dosage Strength : 500MG; 10MG; 20MG; 50MG
Packaging : 7 Or 10 Sachets/Box
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Italy
Chloramphenicol; Phenylephrine; Pyrilamine
Brand Name : Vasofen
Dosage Form :
Dosage Strength : Coll 10 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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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 - 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 - SOLUTION/DROPS;OPHTHALMIC - 0.2%;1%
USFDA APPLICATION NUMBER - 84300
DOSAGE - SYRUP;ORAL - 5MG/5ML;6.25MG/5ML
USFDA APPLICATION NUMBER - 88761
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PharmaCompass offers a list of Phenylephrine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Phenylephrine Hydrochloride manufacturer or Phenylephrine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenylephrine Hydrochloride manufacturer or Phenylephrine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Phenylephrine Hydrochloride API Price utilized in the formulation of products. Phenylephrine Hydrochloride API Price is not always fixed or binding as the Phenylephrine Hydrochloride Price is obtained through a variety of data sources. The Phenylephrine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A L-Pheny lephrine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Pheny lephrine Hydrochloride, including repackagers and relabelers. The FDA regulates L-Pheny lephrine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Pheny lephrine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of L-Pheny lephrine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Pheny lephrine Hydrochloride supplier is an individual or a company that provides L-Pheny lephrine Hydrochloride active pharmaceutical ingredient (API) or L-Pheny lephrine Hydrochloride finished formulations upon request. The L-Pheny lephrine Hydrochloride suppliers may include L-Pheny lephrine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L-Pheny lephrine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Pheny lephrine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Pheny lephrine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of L-Pheny lephrine Hydrochloride DMFs exist exist since differing nations have different regulations, such as L-Pheny lephrine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Pheny lephrine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. L-Pheny lephrine Hydrochloride USDMF includes data on L-Pheny lephrine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Pheny lephrine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Pheny lephrine Hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The L-Pheny lephrine Hydrochloride Drug Master File in Japan (L-Pheny lephrine Hydrochloride JDMF) empowers L-Pheny lephrine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the L-Pheny lephrine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L-Pheny lephrine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of L-Pheny lephrine Hydrochloride 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 L-Pheny lephrine Hydrochloride Drug Master File in Korea (L-Pheny lephrine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of L-Pheny lephrine Hydrochloride. The MFDS reviews the L-Pheny lephrine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the L-Pheny lephrine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a L-Pheny lephrine Hydrochloride 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 L-Pheny lephrine Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of L-Pheny lephrine Hydrochloride suppliers with KDMF on PharmaCompass.
A L-Pheny lephrine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a L-Pheny lephrine Hydrochloride Certificate of Suitability (COS). The purpose of a L-Pheny lephrine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Pheny lephrine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Pheny lephrine Hydrochloride to their clients by showing that a L-Pheny lephrine Hydrochloride CEP has been issued for it. The manufacturer submits a L-Pheny lephrine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Pheny lephrine Hydrochloride CEP holder for the record. Additionally, the data presented in the L-Pheny lephrine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Pheny lephrine Hydrochloride DMF.
A L-Pheny lephrine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Pheny lephrine Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of L-Pheny lephrine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A L-Pheny lephrine Hydrochloride written confirmation (L-Pheny lephrine Hydrochloride WC) is an official document issued by a regulatory agency to a L-Pheny lephrine Hydrochloride manufacturer, verifying that the manufacturing facility of a L-Pheny lephrine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting L-Pheny lephrine Hydrochloride APIs or L-Pheny lephrine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a L-Pheny lephrine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of L-Pheny lephrine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing L-Pheny lephrine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Pheny lephrine Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture L-Pheny lephrine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain L-Pheny lephrine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Pheny lephrine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Pheny lephrine Hydrochloride suppliers with NDC on PharmaCompass.
L-Pheny lephrine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of L-Pheny lephrine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right L-Pheny lephrine Hydrochloride GMP manufacturer or L-Pheny lephrine Hydrochloride GMP API supplier for your needs.
A L-Pheny lephrine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to L-Pheny lephrine Hydrochloride's compliance with L-Pheny lephrine Hydrochloride specifications and serves as a tool for batch-level quality control.
L-Pheny lephrine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each L-Pheny lephrine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
L-Pheny lephrine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Pheny lephrine Hydrochloride EP), L-Pheny lephrine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Pheny lephrine Hydrochloride USP).
