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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.)
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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Registrant Name : KR Pharm Co., Ltd.
Registration Date : 2014-02-18
Registration Number : 20080228-88-D-11-05(1)
Manufacturer Name : Malladi Drug & Pharmaceutica...
Manufacturer Address : 7B&7C, SIPCOT Industrial complex, Ranipet-632 403, Vellore District, India.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2008-02-28
Registration Number : 20080228-88-D-11-05
Manufacturer Name : Malladi Drugs & Pharmaceutic...
Manufacturer Address : Unit-3, 7B&7C, SIPCOT Industrial Complex, Ranipet-632 403, Ranipet District, Tamil Na...
Registrant Name : CTC Bio Co., Ltd.
Registration Date : 2013-07-10
Registration Number : 20130710-88-D-119-08
Manufacturer Name : Siegfried PharmaChemikalien ...
Manufacturer Address : Karlstraße 15-39, 42-44 32423 Minden, Germany
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2012-09-18
Registration Number : 20081128-88-D-28-07(1)
Manufacturer Name : Divi's Laboratories Limited
Manufacturer Address : Chippada Village, Bheemunipatnam Mandal, Vishakapatnam District, Andhra Pradesh, Indi...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2013-05-22
Registration Number : 20081128-88-D-28-07(2)
Manufacturer Name : Divi's Laboratories Ltd
Manufacturer Address : Chippada Villaga, Bheemunipatnam Mandal, Vishakapatnam District, Ahndra Pradesh, Indi...
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2017-08-24
Registration Number : 20081128-88-D-28-07(3)
Manufacturer Name : Divi's Laboratories Limited
Manufacturer Address : Chippada Village, Bheemunipatnam Mandal, Vishakapatnam District, Andhra Pradesh
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2011-10-28
Registration Number : 20071228-88-D-12-04(2)
Manufacturer Name : Iwaki Seiyaku Co., Ltd.
Manufacturer Address : 1700, hamagawa shinden, kakegawa-city, shizuoka-pref(F4)
Registrant Name : Wonpung Pharmaceutical Co., Ltd.
Registration Date : 2011-10-07
Registration Number : 20071228-88-D-12-04(3)
Manufacturer Name : Iwaki Seiyaku Co., Ltd.
Manufacturer Address : 1700, hamagawa shinden, kakegawa-city, shizuoka-pref(F4)1700, hamagawa shinden, kakeg...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2011-05-31
Registration Number : 20071025-88-D-17-02(3)
Manufacturer Name : Syn-tech chem & pharm Co. Lt...
Manufacturer Address : No. 168, kai yuan Rd, hsin-ying Tainan City 73055, Taiwan
Registrant Name : Hwaduk Pharmaceutical Co., Ltd.
Registration Date : 2011-08-19
Registration Number : 20071025-88-D-17-02(5)
Manufacturer Name : Syn-Tech Chem & Pharm Co.Ltd...
Manufacturer Address : No. 168 Kai Yaun Rd., Hsin-Ying, Tainan City 73055, Taiwan
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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
About the Company : Transo-Pharm, founded in 1987, is a fully licensed global distributor of pharmaceutical components for health and veterinary industries. It supports customers throughout the API li...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...
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 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
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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 - 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 meta-Synephrine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of meta-Synephrine hydrochloride, including repackagers and relabelers. The FDA regulates meta-Synephrine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. meta-Synephrine 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 meta-Synephrine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A meta-Synephrine hydrochloride supplier is an individual or a company that provides meta-Synephrine hydrochloride active pharmaceutical ingredient (API) or meta-Synephrine hydrochloride finished formulations upon request. The meta-Synephrine hydrochloride suppliers may include meta-Synephrine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of meta-Synephrine hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A meta-Synephrine hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of meta-Synephrine hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of meta-Synephrine hydrochloride DMFs exist exist since differing nations have different regulations, such as meta-Synephrine hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A meta-Synephrine hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. meta-Synephrine hydrochloride USDMF includes data on meta-Synephrine hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The meta-Synephrine hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 meta-Synephrine hydrochloride Drug Master File in Japan (meta-Synephrine hydrochloride JDMF) empowers meta-Synephrine 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 meta-Synephrine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of meta-Synephrine hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a meta-Synephrine hydrochloride Drug Master File in Korea (meta-Synephrine hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of meta-Synephrine hydrochloride. The MFDS reviews the meta-Synephrine hydrochloride KDMF as part of the drug registration process and uses the information provided in the meta-Synephrine hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a meta-Synephrine 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 meta-Synephrine hydrochloride API can apply through the Korea Drug Master File (KDMF).
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A meta-Synephrine hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a meta-Synephrine hydrochloride Certificate of Suitability (COS). The purpose of a meta-Synephrine hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of meta-Synephrine hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of meta-Synephrine hydrochloride to their clients by showing that a meta-Synephrine hydrochloride CEP has been issued for it. The manufacturer submits a meta-Synephrine hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a meta-Synephrine hydrochloride CEP holder for the record. Additionally, the data presented in the meta-Synephrine hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the meta-Synephrine hydrochloride DMF.
A meta-Synephrine hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. meta-Synephrine 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 meta-Synephrine hydrochloride suppliers with CEP (COS) on PharmaCompass.
A meta-Synephrine hydrochloride written confirmation (meta-Synephrine hydrochloride WC) is an official document issued by a regulatory agency to a meta-Synephrine hydrochloride manufacturer, verifying that the manufacturing facility of a meta-Synephrine hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting meta-Synephrine hydrochloride APIs or meta-Synephrine hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a meta-Synephrine hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of meta-Synephrine 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 meta-Synephrine hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for meta-Synephrine 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 meta-Synephrine 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 meta-Synephrine hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a meta-Synephrine hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of meta-Synephrine hydrochloride suppliers with NDC on PharmaCompass.
meta-Synephrine 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 meta-Synephrine 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 meta-Synephrine hydrochloride GMP manufacturer or meta-Synephrine hydrochloride GMP API supplier for your needs.
A meta-Synephrine hydrochloride CoA (Certificate of Analysis) is a formal document that attests to meta-Synephrine hydrochloride's compliance with meta-Synephrine hydrochloride specifications and serves as a tool for batch-level quality control.
meta-Synephrine hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each meta-Synephrine 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.
meta-Synephrine hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (meta-Synephrine hydrochloride EP), meta-Synephrine hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (meta-Synephrine hydrochloride USP).
