Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Allegra
2. Alpha-(4-(1-carboxy-1-methylethyl)phenyl)-4-hydroxydiphenylmethyl-1-piperidinebutanol
3. Fexofenadine
4. Mdl 16,455a
5. Mdl 16.455
6. Mdl 16455
7. Mdl-16455
8. Telfast
1. 153439-40-8
2. Fexofenadine Hcl
3. Allegra
4. Telfast
5. 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic Acid Hydrochloride
6. Mdl 16,455a
7. 138452-21-8
8. Fexofenadine (hydrochloride)
9. Mdl 16455
10. Mdl-16455a
11. Terfenadine Carboxylate Hydrochloride
12. 2s068b75zu
13. Mdl 16455a
14. 2-(4-{1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl}phenyl)-2-methylpropanoic Acid Hydrochloride
15. 2-[4-[1-hydroxy-4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butyl]phenyl]-2-methylpropanoic Acid;hydrochloride
16. 153439-40-8 (hcl)
17. Dsstox_cid_28642
18. Dsstox_rid_82912
19. Dsstox_gsid_48716
20. Allegra Allergy
21. Allegra Hives
22. Smr000718798
23. Cas-153439-40-8
24. Ncgc00015453-05
25. Children's Allegra Hives
26. Fexofenidine Hydrochloride
27. Children's Allegra Allergy
28. Terfenidine
29. Altiva
30. Unii-2s068b75zu
31. Carboxyterfenadine Hydrochloride
32. Allegra Flash
33. Sr-01000075889
34. Allegra Od
35. Fexofenadine Hydrochloride [usan]
36. Fexofenadine, Hcl
37. Allegra (tn)
38. Terfenidine Carboxylate Hydrochloride
39. Mfcd00865710
40. Fexofenadine Hydrochloride [usan:usp]
41. Fexofenadina Cloridrato
42. Fexofenadine-d10 Hcl
43. Cloridrato De Fexofenadina
44. Clorhidrato De Fexofenadina
45. Chlorhydrate De Fexofenadine
46. Mdl-16455 Hydrochloride
47. Schembl40914
48. Mls001306422
49. Mls001332493
50. Mls001332494
51. Fexofenadine Impurity Standard
52. Spectrum1504179
53. Chebi:5051
54. Chembl1200618
55. Dtxsid5048716
56. Hy-b0801a
57. Fexofenadine Hydrochloride- Bio-x
58. Pharmakon1600-01504179
59. Tox21_113125
60. Nsc758678
61. S3208
62. Akos015907422
63. Tox21_113125_1
64. Ab07499
65. Ccg-213275
66. Cs-4483
67. Fexofenadine Hydrochloride (jp17/usp)
68. Fexofenadine Hydrochloride [mi]
69. Ks-1057
70. Nc00724
71. Nsc 758678
72. Nsc-758678
73. Fexofenadine Hydrochloride [jan]
74. Ncgc00015453-02
75. Ncgc00015453-08
76. Ncgc00092389-01
77. Ncgc00095906-01
78. Ncgc00095906-02
79. (+-)-p-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidino)butyl)-alpha-methylhydratropic Acid Hydrochloride
80. Ac-24745
81. Bf164454
82. Fexofenadine Hydrochloride [mart.]
83. Fexofenadine Hydrochloride [vandf]
84. Fexofenadine Hydrochloride [usp-rs]
85. Fexofenadine Hydrochloride [who-dd]
86. Fexofenadine Hydrochloride, >98% (hplc)
87. Db-043190
88. A3371
89. F0698
90. Ft-0631183
91. M-016455-o
92. Sw199568-2
93. Bim-0050472.0001
94. D00671
95. Fexofenadine Hydrochloride [orange Book]
96. Fexofenadine Hydrochloride [ep Monograph]
97. Fexofenadine Hydrochloride [usp Impurity]
98. 452f218
99. Fexofenadine Hydrochloride [usp Monograph]
100. J-505843
101. Sr-01000075889-6
102. Allegra-d Component Fexofenadine Hydrochloride
103. Q27255526
104. Fexofenadine Hydrochloride 100 Microg/ml In Acetonitrile
105. Fexofenadine Hydrochloride Component Of Allegra-d
106. Z2210694607
107. Fexofenadine Hydrochloride, European Pharmacopoeia (ep) Reference Standard
108. Fexofenadine Hcl, Pharmaceutical Secondary Standard; Certified Reference Material
109. Fexofenadine Hydrochloride, United States Pharmacopeia (usp) Reference Standard
110. (+/-)-p-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidino)butyl)-.alpha.-methylhydratropic Acid, Hydrochloride
111. 2-(4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)piperidin-1-yl)butyl)phenyl)-2-methylpropanoic Acid Hcl
112. 2-(4-{1-hydroxy-4-[4-(hydroxy-diphenyl-methyl)-piperidin-1-yl]-butyl}-phenyl)-2-methyl-propionic Acid
113. 2-(4-{1-hydroxy-4-[4-(hydroxy-diphenyl-methyl)-piperidin-1-yl]-butyl}-phenyl)-2-methyl-propionic Acid; Hydrochloride;fexofenadine Hcl
114. 4-[(4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride
115. 4-[4-[4-(hydroxydiphenylmethyl)-1-pieridinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride
116. 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-alpha,alpha-dimethylbenzeneacetic Acid Hydrochloride
117. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-.alpha.,.alpha.-dimethyl-, Hydrochloride, (+/-)-
118. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-alpha,alpha-dimethyl-, Hydrochloride
119. Benzeneacetic Acid, 4-(1-hydroxy-4-(4-(hydroxydiphenylmethyl)-1-piperidinyl)butyl)-alpha,alpha-dimethyl-, Hydrochloride, (+-)-
| Molecular Weight | 538.1 g/mol |
|---|---|
| Molecular Formula | C32H40ClNO4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 10 |
| Exact Mass | 537.2645865 g/mol |
| Monoisotopic Mass | 537.2645865 g/mol |
| Topological Polar Surface Area | 81 Ų |
| Heavy Atom Count | 38 |
| Formal Charge | 0 |
| Complexity | 678 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Allegra |
| PubMed Health | Fexofenadine/Pseudoephedrine (By mouth) |
| Drug Classes | Antihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination |
| Drug Label | Fexofenadine hydrochloride, the active ingredient of ALLEGRA Tablets, ALLEGRA ODT and ALLEGRA Oral Suspension, is a histamine H1-receptor antagonist with the chemical name ()-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-,-dim... |
| Active Ingredient | Fexofenadine hydrochloride |
| Dosage Form | Suspension |
| Route | Oral |
| Strength | 30mg/5ml |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
| 2 of 4 | |
|---|---|
| Drug Name | Fexofenadine hydrochloride |
| Drug Label | Fexofenadine hydrochloride is a histamine H1-receptor antagonist with the chemical name (benzeneacetic acid hydrochloride. It has the following chemical structure:C32H39NO4Molecular Weight: 538.13Fexofenadine hydrochloride is a white to off-white cry... |
| Active Ingredient | Fexofenadine hydrochloride |
| Dosage Form | Tablet; Suspension |
| Route | oral; Oral |
| Strength | 180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml |
| Market Status | Tentative Approval; Prescription |
| Company | Ranbaxy; Aurolife Pharma; Actavis Mid Atlantic; Teva; Dr Reddys Labs; Sandoz; Mylan; Barr |
| 3 of 4 | |
|---|---|
| Drug Name | Allegra |
| PubMed Health | Fexofenadine/Pseudoephedrine (By mouth) |
| Drug Classes | Antihistamine, Less-Sedating/Decongestant Combination, Antihistamine/Decongestant Combination |
| Drug Label | Fexofenadine hydrochloride, the active ingredient of ALLEGRA Tablets, ALLEGRA ODT and ALLEGRA Oral Suspension, is a histamine H1-receptor antagonist with the chemical name ()-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-,-dim... |
| Active Ingredient | Fexofenadine hydrochloride |
| Dosage Form | Suspension |
| Route | Oral |
| Strength | 30mg/5ml |
| Market Status | Prescription |
| Company | Sanofi Aventis Us |
| 4 of 4 | |
|---|---|
| Drug Name | Fexofenadine hydrochloride |
| Drug Label | Fexofenadine hydrochloride is a histamine H1-receptor antagonist with the chemical name (benzeneacetic acid hydrochloride. It has the following chemical structure:C32H39NO4Molecular Weight: 538.13Fexofenadine hydrochloride is a white to off-white cry... |
| Active Ingredient | Fexofenadine hydrochloride |
| Dosage Form | Tablet; Suspension |
| Route | oral; Oral |
| Strength | 180mg; 30mg/5ml; 60mg; 30mg; 30mg/ml |
| Market Status | Tentative Approval; Prescription |
| Company | Ranbaxy; Aurolife Pharma; Actavis Mid Atlantic; Teva; Dr Reddys Labs; Sandoz; Mylan; Barr |
Anti-Allergic Agents
Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)
Histamine H1 Antagonists, Non-Sedating
A class of non-sedating drugs that bind to but do not activate histamine receptors (DRUG INVERSE AGONISM), thereby blocking the actions of histamine or histamine agonists. These antihistamines represent a heterogenous group of compounds with differing chemical structures, adverse effects, distribution, and metabolism. Compared to the early (first generation) antihistamines, these non-sedating antihistamines have greater receptor specificity, lower penetration of BLOOD-BRAIN BARRIER, and are less likely to cause drowsiness or psychomotor impairment. (See all compounds classified as Histamine H1 Antagonists, Non-Sedating.)
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
With Virupaksha, you get a quality product with on-time delivery.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-06-27
DMF Number : 23070
Submission : 2009-08-10
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-15
Pay. Date : 2020-03-26
DMF Number : 34645
Submission : 2020-03-12
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-12
Pay. Date : 2020-12-04
DMF Number : 15757
Submission : 2001-12-05
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-19
Pay. Date : 2016-07-12
DMF Number : 30604
Submission : 2016-08-16
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18949
Submission : 2005-11-09
Status : Inactive
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18948
Submission : 2005-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18800
Submission : 2005-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16029
Submission : 2002-06-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15419
Submission : 2001-05-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19816
Submission : 2006-09-29
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SUSPENSION;ORAL - 30MG/5ML
USFDA APPLICATION NUMBER - 201373
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
USFDA APPLICATION NUMBER - 20786
DOSAGE - TABLET;ORAL - 180MG
USFDA APPLICATION NUMBER - 20872
DOSAGE - TABLET;ORAL - 30MG **Federal Registe...DOSAGE - TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20872
DOSAGE - TABLET;ORAL - 60MG
USFDA APPLICATION NUMBER - 20872
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
USFDA APPLICATION NUMBER - 21704
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
USFDA APPLICATION NUMBER - 21909
DOSAGE - SUSPENSION;ORAL - 30MG/5ML
USFDA APPLICATION NUMBER - 21963
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Minbiotech
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vertellus
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Direct Compression
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Granulation
Solubilizers
Taste Masking
Controlled & Modified Release
Lubricants & Glidants
Film Formers & Plasticizers
Chewable & Orodispersible Aids
Topical
Parenteral
Co-Processed Excipients
Rheology Modifiers
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Coloring Agents
Surfactant & Foaming Agents
Vegetarian Capsules
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Analytical Methods
ABOUT THIS PAGE
89
PharmaCompass offers a list of Fexofenadine 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 Fexofenadine Hydrochloride manufacturer or Fexofenadine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fexofenadine Hydrochloride manufacturer or Fexofenadine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Fexofenadine Hydrochloride API Price utilized in the formulation of products. Fexofenadine Hydrochloride API Price is not always fixed or binding as the Fexofenadine Hydrochloride Price is obtained through a variety of data sources. The Fexofenadine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 153439-40-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 153439-40-8, including repackagers and relabelers. The FDA regulates 153439-40-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 153439-40-8 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 153439-40-8 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 153439-40-8 supplier is an individual or a company that provides 153439-40-8 active pharmaceutical ingredient (API) or 153439-40-8 finished formulations upon request. The 153439-40-8 suppliers may include 153439-40-8 API manufacturers, exporters, distributors and traders.
click here to find a list of 153439-40-8 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 153439-40-8 DMF (Drug Master File) is a document detailing the whole manufacturing process of 153439-40-8 active pharmaceutical ingredient (API) in detail. Different forms of 153439-40-8 DMFs exist exist since differing nations have different regulations, such as 153439-40-8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 153439-40-8 DMF submitted to regulatory agencies in the US is known as a USDMF. 153439-40-8 USDMF includes data on 153439-40-8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 153439-40-8 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 153439-40-8 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 153439-40-8 Drug Master File in Japan (153439-40-8 JDMF) empowers 153439-40-8 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 153439-40-8 JDMF during the approval evaluation for pharmaceutical products. At the time of 153439-40-8 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 153439-40-8 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 153439-40-8 Drug Master File in Korea (153439-40-8 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 153439-40-8. The MFDS reviews the 153439-40-8 KDMF as part of the drug registration process and uses the information provided in the 153439-40-8 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 153439-40-8 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 153439-40-8 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 153439-40-8 suppliers with KDMF on PharmaCompass.
A 153439-40-8 CEP of the European Pharmacopoeia monograph is often referred to as a 153439-40-8 Certificate of Suitability (COS). The purpose of a 153439-40-8 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 153439-40-8 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 153439-40-8 to their clients by showing that a 153439-40-8 CEP has been issued for it. The manufacturer submits a 153439-40-8 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 153439-40-8 CEP holder for the record. Additionally, the data presented in the 153439-40-8 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 153439-40-8 DMF.
A 153439-40-8 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 153439-40-8 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 153439-40-8 suppliers with CEP (COS) on PharmaCompass.
A 153439-40-8 written confirmation (153439-40-8 WC) is an official document issued by a regulatory agency to a 153439-40-8 manufacturer, verifying that the manufacturing facility of a 153439-40-8 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 153439-40-8 APIs or 153439-40-8 finished pharmaceutical products to another nation, regulatory agencies frequently require a 153439-40-8 WC (written confirmation) as part of the regulatory process.
click here to find a list of 153439-40-8 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 153439-40-8 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 153439-40-8 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 153439-40-8 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 153439-40-8 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 153439-40-8 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 153439-40-8 suppliers with NDC on PharmaCompass.
153439-40-8 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 153439-40-8 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 153439-40-8 GMP manufacturer or 153439-40-8 GMP API supplier for your needs.
A 153439-40-8 CoA (Certificate of Analysis) is a formal document that attests to 153439-40-8's compliance with 153439-40-8 specifications and serves as a tool for batch-level quality control.
153439-40-8 CoA mostly includes findings from lab analyses of a specific batch. For each 153439-40-8 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.
153439-40-8 may be tested according to a variety of international standards, such as European Pharmacopoeia (153439-40-8 EP), 153439-40-8 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (153439-40-8 USP).
