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1. Citrate, Norflex Orphenadrine
2. Citrate, Orphenadrine
3. Disipal
4. Hydrochloride, Orphenadrine
5. Lysantin
6. Mefenamine
7. Mefenamine, Sodium
8. Mephenamine
9. Methyldiphenylhydramine
10. Norflex
11. Norflex Orphenadrine Citrate
12. Orphenadrine
13. Orphenadrine Citrate, Norflex
14. Orphenadrine Hydrochloride
15. Sodium Mefenamine
1. 4682-36-4
2. Norflex
3. Banflex
4. Orphenadrine Dihydrogen Citrate
5. Flexon
6. Orphenadrine (citrate)
7. Flexoject
8. X-otag
9. Orphenadrine Citrate Salt
10. 2-hydroxypropane-1,2,3-tricarboxylic Acid; Dimethyl({2-[(2-methylphenyl)(phenyl)methoxy]ethyl})amine
11. 4596-23-0
12. Nsc-757238
13. Orphenadrine Citrate [usp]
14. N,n-dimethyl-2-[(2-methylphenyl)-phenylmethoxy]ethanamine;2-hydroxypropane-1,2,3-tricarboxylic Acid
15. Orphenadrine Citrate (norflex)
16. Chebi:7790
17. X0a40n8i4s
18. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethanamine 2-hydroxypropane-1,2,3-tricarboxylate
19. Ncgc00094745-01
20. Plenactol
21. Euflex
22. Flexor
23. Tega-flex
24. Orphenadrine Citrate (usp)
25. Dsstox_cid_24678
26. Dsstox_rid_80390
27. Dsstox_gsid_44678
28. Norflex (pharmaceutical)
29. Orphenadrinecitrate
30. N,n-dimethyl-2-(phenyl(o-tolyl)methoxy)ethan-1-amine 2-hydroxypropane-1,2,3-tricarboxylate
31. Cas-4682-36-4
32. Einecs 225-137-5
33. Unii-x0a40n8i4s
34. Norflex (tn)
35. Orphenadine Citrate
36. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)
37. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
38. Mls000069549
39. Schembl119470
40. Spectrum1500447
41. Chembl1200395
42. Dtxsid8044678
43. Hms502k15
44. Hy-b0369a
45. Orphenadrine Citrate [mi]
46. Hms1920d10
47. Hms2091l10
48. Hms2231j06
49. Hms3259m21
50. Hms3370m12
51. Hms3651a10
52. Hms3884m22
53. Pharmakon1600-01500447
54. Citric Acid; N,n-dimethyl-2-[o-tolyl(phenyl)methoxy]ethanamine
55. O-methyldiphenhydramine Citrate Salt
56. Orphenadrine Citrate [vandf]
57. Tox21_111323
58. Tox21_113543
59. Tox21_301079
60. Ccg-40242
61. Nsc757238
62. Orphenadrine Citrate [mart.]
63. Orphenadrine Citrate [who-dd]
64. Akos008132385
65. Tox21_111323_1
66. Nc00525
67. Nsc 757238
68. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate (1:1)
69. Ethylamine, N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)-, Citrate (1:1)
70. Ncgc00015771-13
71. Ncgc00094745-02
72. Ncgc00094745-03
73. Ncgc00254980-01
74. As-74807
75. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
76. Orphenadrine Citrate [ep Impurity]
77. Orphenadrine Citrate [orange Book]
78. Smr000058817
79. Orphenadrine Citrate [ep Monograph]
80. Orphenadrine Citrate [usp Monograph]
81. Ft-0655842
82. Ft-0673305
83. S2054
84. Sw102176-4
85. En300-53019
86. Norgesic Component Orphenadrine Citrate
87. C75247
88. D00774
89. Invagesic Component Orphenadrine Citrate
90. Orphenadrine Citrate Component Of Norgesic
91. Orphengesic Component Orphenadrine Citrate
92. A826945
93. Orphenadrine Citrate Component Of Invagesic
94. Orphenadrine Citrate Component Of Orphengesic
95. Sr-01000002975-5
96. Invagesic Forte Component Orphenadrine Citrate
97. Orphengesic Forte Component Orphenadrine Citrate
98. Q27107584
99. Orphenadrine Citrate Component Of Invagesic Forte
100. Orphenadrine Citrate Component Of Orphengesic Forte
101. Beta-dimethylaminoethyl 2-methylbenzhydryl Ether Citrate Salt
102. N,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate
103. (+-)-n,n-dimethyl-2-((o-methyl-alpha-phenylbenzyl)oxy)ethylamine Citrate
104. (+/-)-n,n-dimethyl-2-((o-methyl-.alpha.-phenylbenzyl)oxy)ethylamine Citrate (1:1)
105. Ethanamine, N,n-dimethyl-2-((2-methylphenyl)phenylmethoxy)-, (+/-)-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
106. Ethanamine, N,n-dimethyl-2-[(2-methylphenyl)phenylmethoxy]-,2-hydroxy-1,2,3-propanetricarboxylate (1:1)
107. N,n-dimethyl-2-[(2-methylphenyl)(phenyl)methoxy]ethanamine 2-hydroxypropane-1,2,3-tricarboxylate
| Molecular Weight | 461.5 g/mol |
|---|---|
| Molecular Formula | C24H31NO8 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 11 |
| Exact Mass | 461.20496695 g/mol |
| Monoisotopic Mass | 461.20496695 g/mol |
| Topological Polar Surface Area | 145 Ų |
| Heavy Atom Count | 33 |
| Formal Charge | 0 |
| Complexity | 488 |
| 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 | Norflex |
| PubMed Health | Orphenadrine |
| Drug Classes | Skeletal Muscle Relaxant, Centrally Acting |
| Drug Label | Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl... |
| Active Ingredient | Orphenadrine citrate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 30mg/ml |
| Market Status | Prescription |
| Company | Medicis |
| 2 of 4 | |
|---|---|
| Drug Name | Orphenadrine citrate |
| PubMed Health | Orphenadrine Citrate/Aspirin/Caffeine (By mouth) |
| Drug Classes | Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination |
| Drug Label | Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i... |
| Active Ingredient | Orphenadrine citrate |
| Dosage Form | Tablet, extended release; Injectable |
| Route | Injection; Oral |
| Strength | 30mg/ml; 100mg |
| Market Status | Prescription |
| Company | Impax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn |
| 3 of 4 | |
|---|---|
| Drug Name | Norflex |
| PubMed Health | Orphenadrine |
| Drug Classes | Skeletal Muscle Relaxant, Centrally Acting |
| Drug Label | Orphenadrine citrate is the citrate salt of orphenadrine (2-dimethylaminoethyl 2- methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly solubl... |
| Active Ingredient | Orphenadrine citrate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 30mg/ml |
| Market Status | Prescription |
| Company | Medicis |
| 4 of 4 | |
|---|---|
| Drug Name | Orphenadrine citrate |
| PubMed Health | Orphenadrine Citrate/Aspirin/Caffeine (By mouth) |
| Drug Classes | Skeletal Muscle Relaxant, Centrally Acting/Salicylate, Aspirin Combination |
| Drug Label | Orphenadrine citrate is the citrate salt of orphenadrine. It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol. The chemical name of orphenadrine citrate i... |
| Active Ingredient | Orphenadrine citrate |
| Dosage Form | Tablet, extended release; Injectable |
| Route | Injection; Oral |
| Strength | 30mg/ml; 100mg |
| Market Status | Prescription |
| Company | Impax Pharms; Tedor Pharma; Sandoz; Invagen Pharms; Watson Labs; Gavis Pharms; Sagent Pharms; Eurohlth Intl; Akorn |
Cytochrome P-450 CYP2B6 Inhibitors
Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2B6. (See all compounds classified as Cytochrome P-450 CYP2B6 Inhibitors.)
Antiparkinson Agents
Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)
Muscarinic Antagonists
Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)
Muscle Relaxants, Central
A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)
Parasympatholytics
Agents that inhibit the actions of the parasympathetic nervous system. The major group of drugs used therapeutically for this purpose is the MUSCARINIC ANTAGONISTS. (See all compounds classified as Parasympatholytics.)
M - Musculo-skeletal system
M03 - Muscle relaxants
M03B - Muscle relaxants, centrally acting agents
M03BC - Ethers, chemically close to antihistamines
M03BC01 - Orphenadrine (citrate)
API SUPPLIERS
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33901
Submission : 2019-05-29
Status : Active
Type : II
Certificate Number : CEP 2022-094 - Rev 00
Issue Date : 2024-05-21
Type : Chemical
Substance Number : 1759
Status : Valid
Date of Issue : 2023-04-18
Valid Till : 2026-04-17
Written Confirmation Number : WC-0555
Address of the Firm :
NDC Package Code : 71554-012
Start Marketing Date : 2019-04-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20201013-209-J-733
Manufacturer Name : RL Fine Chem Pvt Ltd
Manufacturer Address : Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Gowribidanur, Chikkaballapur Dist., Karnataka-561 208, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38456
Submission : 2023-06-05
Status : Active
Type : II
Date of Issue : 2022-10-14
Valid Till : 2025-07-28
Written Confirmation Number : WC-0445
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-16
Pay. Date : 2013-07-05
DMF Number : 5722
Submission : 1985-02-22
Status : Active
Type : II
NDC Package Code : 22568-1022
Start Marketing Date : 2021-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-11-13
Pay. Date : 2014-10-31
DMF Number : 14971
Submission : 2000-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7108
Submission : 1987-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4457
Submission : 1982-02-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4811
Submission : 1983-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2942
Submission : 1977-05-09
Status : Inactive
Type : II
NDC Package Code : 46016-0140
Start Marketing Date : 2003-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7108
Submission : 1987-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-16
Pay. Date : 2013-07-05
DMF Number : 5722
Submission : 1985-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4457
Submission : 1982-02-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4811
Submission : 1983-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-13
Pay. Date : 2014-10-31
DMF Number : 14971
Submission : 2000-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2942
Submission : 1977-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38456
Submission : 2023-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33901
Submission : 2019-05-29
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7837
Submission : 1988-12-20
Status : Inactive
Type : II
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Regulatory Info : Generic
Registration Country : Pakistan
Acetaminophen/Paracetamol; Norflex
Brand Name : Cetol Plus
Dosage Form : TABLET
Dosage Strength : 650MG; 50MG
Packaging : as per requirement
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Pakistan
Packaging : as per requirement
Regulatory Info : Generic
Acetaminophen/Paracetamol; Norflex
Dosage : TABLET
Dosage Strength : 650MG; 50MG
Brand Name : Cetol Plus
Approval Date :
Application Number :
Registration Country : Pakistan
Regulatory Info :
Registration Country : India
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Dosage Form : Tablet
Dosage Strength : 50MG
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Regulatory Info :
Registration Country : India
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Regulatory Info :
Dosage : Tablet
Dosage Strength : 50MG
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Registration Country : India
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US Medicaid Prescriptions
Company : Akorn Inc.
Orphenadrine Citrate
Drug Cost (USD) : 303,217
Year : 2023
Prescribers : 3177
Prescriptions : 4163
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Company : West-Ward/Hikma
Orphenadrine Citrate
Drug Cost (USD) : 229,391
Year : 2023
Prescribers : 2670
Prescriptions : 3611
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Company : Amneal Pharmace
Orphenadrine Citrate
Drug Cost (USD) : 13,465
Year : 2023
Prescribers : 374
Prescriptions : 516
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Company : Gavis/Lupin
Orphenadrine Citrate
Drug Cost (USD) : 1,897,075
Year : 2023
Prescribers : 24422
Prescriptions : 48010
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Company : Sandoz
Orphenadrine Citrate
Drug Cost (USD) : 26,345
Year : 2023
Prescribers : 494
Prescriptions : 748
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Company : Amneal Pharmace
Orphenadrine Citrate
Drug Cost (USD) : 16,107
Year : 2022
Prescribers : 310
Prescriptions : 504
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Company : Actavis/Teva
Orphenadrine Citrate
Drug Cost (USD) : 2,527
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Prescribers : 21
Prescriptions : 30
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Company : Akorn Inc.
Orphenadrine Citrate
Drug Cost (USD) : 676,891
Year : 2022
Prescribers : 4193
Prescriptions : 6410
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Company : Sandoz
Orphenadrine Citrate
Drug Cost (USD) : 53,319
Year : 2022
Prescribers : 798
Prescriptions : 1132
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Company : West-Ward/Hikma
Orphenadrine Citrate
Drug Cost (USD) : 70,050
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Prescribers : 832
Prescriptions : 1120
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
31
PharmaCompass offers a list of Orphenadrine 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 Orphenadrine manufacturer or Orphenadrine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Orphenadrine manufacturer or Orphenadrine supplier.
PharmaCompass also assists you with knowing the Orphenadrine API Price utilized in the formulation of products. Orphenadrine API Price is not always fixed or binding as the Orphenadrine Price is obtained through a variety of data sources. The Orphenadrine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Orphenadrine citrate (Norflex) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orphenadrine citrate (Norflex), including repackagers and relabelers. The FDA regulates Orphenadrine citrate (Norflex) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orphenadrine citrate (Norflex) supplier is an individual or a company that provides Orphenadrine citrate (Norflex) active pharmaceutical ingredient (API) or Orphenadrine citrate (Norflex) finished formulations upon request. The Orphenadrine citrate (Norflex) suppliers may include Orphenadrine citrate (Norflex) API manufacturers, exporters, distributors and traders.
click here to find a list of Orphenadrine citrate (Norflex) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Orphenadrine citrate (Norflex) DMF (Drug Master File) is a document detailing the whole manufacturing process of Orphenadrine citrate (Norflex) active pharmaceutical ingredient (API) in detail. Different forms of Orphenadrine citrate (Norflex) DMFs exist exist since differing nations have different regulations, such as Orphenadrine citrate (Norflex) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orphenadrine citrate (Norflex) DMF submitted to regulatory agencies in the US is known as a USDMF. Orphenadrine citrate (Norflex) USDMF includes data on Orphenadrine citrate (Norflex)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orphenadrine citrate (Norflex) USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Orphenadrine citrate (Norflex) Drug Master File in Korea (Orphenadrine citrate (Norflex) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Orphenadrine citrate (Norflex). The MFDS reviews the Orphenadrine citrate (Norflex) KDMF as part of the drug registration process and uses the information provided in the Orphenadrine citrate (Norflex) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) API can apply through the Korea Drug Master File (KDMF).
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A Orphenadrine citrate (Norflex) CEP of the European Pharmacopoeia monograph is often referred to as a Orphenadrine citrate (Norflex) Certificate of Suitability (COS). The purpose of a Orphenadrine citrate (Norflex) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orphenadrine citrate (Norflex) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orphenadrine citrate (Norflex) to their clients by showing that a Orphenadrine citrate (Norflex) CEP has been issued for it. The manufacturer submits a Orphenadrine citrate (Norflex) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orphenadrine citrate (Norflex) CEP holder for the record. Additionally, the data presented in the Orphenadrine citrate (Norflex) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orphenadrine citrate (Norflex) DMF.
A Orphenadrine citrate (Norflex) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orphenadrine citrate (Norflex) CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Orphenadrine citrate (Norflex) written confirmation (Orphenadrine citrate (Norflex) WC) is an official document issued by a regulatory agency to a Orphenadrine citrate (Norflex) manufacturer, verifying that the manufacturing facility of a Orphenadrine citrate (Norflex) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Orphenadrine citrate (Norflex) APIs or Orphenadrine citrate (Norflex) finished pharmaceutical products to another nation, regulatory agencies frequently require a Orphenadrine citrate (Norflex) WC (written confirmation) as part of the regulatory process.
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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 Orphenadrine citrate (Norflex) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orphenadrine citrate (Norflex) NDC to their finished compounded human drug products, they may choose to do so.
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Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) 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 Orphenadrine citrate (Norflex) GMP manufacturer or Orphenadrine citrate (Norflex) GMP API supplier for your needs.
A Orphenadrine citrate (Norflex) CoA (Certificate of Analysis) is a formal document that attests to Orphenadrine citrate (Norflex)'s compliance with Orphenadrine citrate (Norflex) specifications and serves as a tool for batch-level quality control.
Orphenadrine citrate (Norflex) CoA mostly includes findings from lab analyses of a specific batch. For each Orphenadrine citrate (Norflex) 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.
Orphenadrine citrate (Norflex) may be tested according to a variety of international standards, such as European Pharmacopoeia (Orphenadrine citrate (Norflex) EP), Orphenadrine citrate (Norflex) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orphenadrine citrate (Norflex) USP).
