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1. Dhep
2. Diclofenac 1-(2-hydroxyethyl)pyrrolidinium Salt
3. Diclofenac Hydroxyethylpyrrolidine
4. Diclofenac-epolamine
5. Diclofenac-n-(2-hydroxyethyl) Pyrrolidine
6. Diep
7. Flector
8. N-(2-hydroxyethyl)pyrrolidinium (2-((2,6-dichlorophenyl)amino)phenyl)acetate
1. Flector
2. Diclofenac Hydroxyethylpyrrolidine
3. Diep
4. Dhep
5. Diclofenac Epolaminum
6. Diclofenac-epolamine
7. X5f8ekl9zg
8. 2-[2-(2,6-dichloroanilino)phenyl]acetic Acid;2-pyrrolidin-1-ylethanol
9. N-(2-hydroxyethyl)pyrrolidinium (2-((2,6-dichlorophenyl)amino)phenyl)acetate
10. 2-((2,6-dichlorophenyl)amino)benzeneacetic Acid, Compd. With 1-pyrrolidineethanol (1:1)
11. Diclofenac 1-(2-hydroxyethyl)pyrrolidinium Salt
12. Dhep Plaster
13. Benzeneacetic Acid, 2-((2,6-dichlorophenyl)amino)-, Compd. With 1-pyrrolidineethanol (1:1)
14. Chebi:48296
15. Unii-x5f8ekl9zg
16. Flector (tn)
17. Licart
18. Diclofenac-n-(2-hydroxyethyl) Pyrrolidine
19. Schembl1006944
20. Chembl1201180
21. Dtxsid80152531
22. Diclofenac Epolamine [vandf]
23. Diclofenac Epolamine [mart.]
24. S5737
25. Diclofenac Epolamine [who-dd]
26. Diclofenac Hydroxyethylpirrolidine
27. Diclofenac Epolamine [orange Book]
28. D07818
29. 528d502
30. Diclofenac Acid N-(2-hydroxyetheyl) Pyrrolidine Salt
31. Q27121125
| Molecular Weight | 411.3 g/mol |
|---|---|
| Molecular Formula | C20H24Cl2N2O3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 6 |
| Exact Mass | 410.1163980 g/mol |
| Monoisotopic Mass | 410.1163980 g/mol |
| Topological Polar Surface Area | 72.8 Ų |
| Heavy Atom Count | 27 |
| Formal Charge | 0 |
| Complexity | 363 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| 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 | Flector |
| PubMed Health | Diclofenac |
| Drug Classes | Analgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent |
| Drug Label | Flector Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and coveredwith a polypropylene film release liner. The release liner is emoved prior to... |
| Active Ingredient | Diclofenac epolamine |
| Dosage Form | Patch |
| Route | Topical |
| Strength | 1.3% |
| Market Status | Prescription |
| Company | Inst Biochem |
| 2 of 2 | |
|---|---|
| Drug Name | Flector |
| PubMed Health | Diclofenac |
| Drug Classes | Analgesic, Anti-Inflammatory, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent, Ophthalmologic Agent |
| Drug Label | Flector Patch (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and coveredwith a polypropylene film release liner. The release liner is emoved prior to... |
| Active Ingredient | Diclofenac epolamine |
| Dosage Form | Patch |
| Route | Topical |
| Strength | 1.3% |
| Market Status | Prescription |
| Company | Inst Biochem |
Anti-Inflammatory Agents, Non-Steroidal
Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
Date of Issue : 2022-02-22
Valid Till : 2026-12-31
Written Confirmation Number : TFDA-0002291
Address of the Firm :
Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.
NDC Package Code : 51604-1159
Start Marketing Date : 2013-07-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23909
Submission : 2010-06-18
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26112
Submission : 2012-05-31
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-03
Pay. Date : 2014-04-30
DMF Number : 24962
Submission : 2011-05-05
Status : Active
Type : II
NDC Package Code : 54871-1093
Start Marketing Date : 2013-02-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25224
Submission : 2011-09-16
Status : Active
Type : II
Date of Issue : 2025-08-26
Valid Till : 2028-08-25
Written Confirmation Number : WC-0134
Address of the Firm :
NDC Package Code : 62512-0046
Start Marketing Date : 2010-09-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24522
Submission : 2011-01-04
Status : Inactive
Type : II


Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2014-02-18
Registration Number : 20140218-80-D-134-19
Manufacturer Name : Samoh Pharmaceutical Co., Ltd. @ [Starting material (diclofenac sodium) manufacturer] Ningbo Smart Pharmaceutical Co., Ltd.
Manufacturer Address : 63@No.1 , Yicheng Road, Beilun District, Ningbo, China, Okgucheonseo-ro 81beon-gil, Siheung-si, Gyeonggi-do .

Registrant Name : Redox Bio Co., Ltd.
Registration Date : 2012-11-21
Registration Number : 20121121-80-D-117-16
Manufacturer Name : Redox Bio Co., Ltd. @ [Diclofenac Manufacturer] Hebei Ausun Gaobo Biotechnology Co., Ltd.
Manufacturer Address : 83, Pharmaceutical Complex 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @[Diclofenac Manufacturer] Mengshang Village, Xisu township, Yongnian district, Handan City, Hebei, China

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25929
Submission : 2012-04-03
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25224
Submission : 2011-09-16
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26112
Submission : 2012-05-31
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-03-03
Pay. Date : 2014-04-30
DMF Number : 24962
Submission : 2011-05-05
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23909
Submission : 2010-06-18
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24522
Submission : 2011-01-04
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Dipharma is a leading European manufacturer of Active Pharmaceutical Ingredients that has been developing innovative and proprietary processes since 1949. We support our custome...

About the Company : Through years' researching and improving, Yung Zip Chemical had laid the groundwork for the technology and quality, also started expanding its business scope, Yung Zip started serv...

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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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RLD : Yes
TE Code :
Brand Name : FLECTOR
Dosage Form : SYSTEM;TOPICAL
Dosage Strength : 1.3%
Approval Date : 2007-01-31
Application Number : 21234
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Brand Name : LICART
Dosage Form : SYSTEM;TOPICAL
Dosage Strength : 1.3%
Approval Date : 2018-12-19
Application Number : 206976
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Flectormed
Dosage Form : Medicinal Adhesive Dressing
Dosage Strength : 180MG
Packaging :
Approval Date : 23-03-2018
Application Number : 82182
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Flector
Dosage Form : Patch
Dosage Strength : 140mg
Packaging :
Approval Date : 13-08-2004
Application Number : 2.00E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Alterflex
Dosage Form : Patch
Dosage Strength : 0.01
Packaging :
Approval Date : 26-08-2005
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Perskindol Diclofenac Patch
Dosage Form : Patch
Dosage Strength : 180.05mg
Packaging :
Approval Date : 03/05/2023
Application Number : 69254
Regulatory Info : Allowed
Registration Country : Switzerland

Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Flector EP
Dosage Form : Granules
Dosage Strength : 32.5mg
Packaging :
Approval Date : 13/12/1995
Application Number : 49065
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Flexor EP
Dosage Form : Effervescent Granule
Dosage Strength : 65mg
Packaging :
Approval Date : 13/12/1995
Application Number : 49065
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Flexor EP Tissugel
Dosage Form : Patch
Dosage Strength : 181mg
Packaging :
Approval Date : 25/06/1993
Application Number : 52022
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Flexor EP
Dosage Form : Gel
Dosage Strength : 12.92mg/g
Packaging :
Approval Date : 28/03/1991
Application Number : 50716
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Diclofenac Epolamine; Heparin Sodium
Brand Name : Flectoparin Tissugel
Dosage Form : Patch
Dosage Strength :
Packaging :
Approval Date : 14/07/2006
Application Number : 57347
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Diclofenac Epolamine; Heparin Sodium
Brand Name : Flexor Plus Tissugel
Dosage Form : Patch
Dosage Strength :
Packaging :
Approval Date : 23/03/2016
Application Number : 65998
Regulatory Info : Allowed
Registration Country : Switzerland

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ABOUT THIS PAGE
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PharmaCompass offers a list of Diclofenac Epolamine 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 Diclofenac Epolamine manufacturer or Diclofenac Epolamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diclofenac Epolamine manufacturer or Diclofenac Epolamine supplier.
PharmaCompass also assists you with knowing the Diclofenac Epolamine API Price utilized in the formulation of products. Diclofenac Epolamine API Price is not always fixed or binding as the Diclofenac Epolamine Price is obtained through a variety of data sources. The Diclofenac Epolamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Diclofenac Epolamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diclofenac Epolamine, including repackagers and relabelers. The FDA regulates Diclofenac Epolamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diclofenac Epolamine 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 Diclofenac Epolamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diclofenac Epolamine supplier is an individual or a company that provides Diclofenac Epolamine active pharmaceutical ingredient (API) or Diclofenac Epolamine finished formulations upon request. The Diclofenac Epolamine suppliers may include Diclofenac Epolamine API manufacturers, exporters, distributors and traders.
click here to find a list of Diclofenac Epolamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diclofenac Epolamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Diclofenac Epolamine active pharmaceutical ingredient (API) in detail. Different forms of Diclofenac Epolamine DMFs exist exist since differing nations have different regulations, such as Diclofenac Epolamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diclofenac Epolamine DMF submitted to regulatory agencies in the US is known as a USDMF. Diclofenac Epolamine USDMF includes data on Diclofenac Epolamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diclofenac Epolamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diclofenac Epolamine suppliers with USDMF 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 Diclofenac Epolamine Drug Master File in Korea (Diclofenac Epolamine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diclofenac Epolamine. The MFDS reviews the Diclofenac Epolamine KDMF as part of the drug registration process and uses the information provided in the Diclofenac Epolamine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Diclofenac Epolamine 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 Diclofenac Epolamine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Diclofenac Epolamine suppliers with KDMF on PharmaCompass.
A Diclofenac Epolamine written confirmation (Diclofenac Epolamine WC) is an official document issued by a regulatory agency to a Diclofenac Epolamine manufacturer, verifying that the manufacturing facility of a Diclofenac Epolamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Diclofenac Epolamine APIs or Diclofenac Epolamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Diclofenac Epolamine WC (written confirmation) as part of the regulatory process.
click here to find a list of Diclofenac Epolamine 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 Diclofenac Epolamine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diclofenac Epolamine 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 Diclofenac Epolamine 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 Diclofenac Epolamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diclofenac Epolamine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diclofenac Epolamine suppliers with NDC on PharmaCompass.
Diclofenac Epolamine 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 Diclofenac Epolamine 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 Diclofenac Epolamine GMP manufacturer or Diclofenac Epolamine GMP API supplier for your needs.
A Diclofenac Epolamine CoA (Certificate of Analysis) is a formal document that attests to Diclofenac Epolamine's compliance with Diclofenac Epolamine specifications and serves as a tool for batch-level quality control.
Diclofenac Epolamine CoA mostly includes findings from lab analyses of a specific batch. For each Diclofenac Epolamine 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.
Diclofenac Epolamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Diclofenac Epolamine EP), Diclofenac Epolamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diclofenac Epolamine USP).