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1. Adolquir
2. Badyket
3. Dexketoprofen Trometamol
4. Enangel
5. Enantyum
6. Keral
7. Ketesse
8. Quiralam
9. Quirgel
10. Sympal
1. (s)-(+)-ketoprofen
2. 22161-81-5
3. (s)-ketoprofen
4. (+)-ketoprofen
5. (s)-2-(3-benzoylphenyl)propanoic Acid
6. (2s)-2-(3-benzoylphenyl)propanoic Acid
7. S-(+)-ketoprofen
8. Dexketoprofen [inn]
9. Arveles
10. (+)-3-benzoylhydratropic Acid
11. (+)-(s)-m-benzoylhydratropic Acid
12. Hydratropic Acid, M-benzoyl-, (+)-
13. Ketoprofen, (s)-
14. (s)-3-benzoyl-alpha-methylbenzeneacetic Acid
15. Chembl75435
16. (s)-(+)-2-(3-benzoylphenyl)propionic Acid
17. Chebi:76128
18. 6kd9e78x68
19. Dexketoprofen (inn)
20. (2s)-2-[3-(benzenecarbonyl)phenyl]propanoic Acid
21. Smr000857177
22. Dexketoprofen [inn:ban]
23. Unii-6kd9e78x68
24. 9kl
25. Mfcd00673316
26. Biomolki_000007
27. Biomolki2_000017
28. Schembl66987
29. Bmk1-b7
30. Mls001333189
31. Mls001333190
32. Benzeneacetic Acid, 3-benzoyl-alpha-methyl-, (s)-
33. Dexketoprofen [who-dd]
34. Zinc5560
35. (s)-(+)-ketoprofen, 99%
36. Dtxsid40905141
37. Hms2090m22
38. Hms2234m14
39. Bcp13810
40. Hy-b2137
41. Bdbm50088570
42. S5192
43. 2-(3-benzoyl-phenyl)-propionic Acid
44. Akos015913672
45. Ac-8103
46. Ccg-100611
47. Cs-8173
48. Db09214
49. Ncgc00142585-01
50. Ncgc00142585-02
51. As-17683
52. Bk166230
53. (s)-2-(3-benzoyl-phenyl)-propionic Acid
54. (+)-2-(3-benzoylphenyl)propionic Acid
55. (s)-(+)-2-(3-benzoylphenyl) Propionic Acid
56. (s)-(+)-3-benzoyl-?-methylbenzeneacetic Acid
57. D07269
58. D94685
59. (2s)-2-(3-benzoylphenyl)propionic Acid
60. Ab00918363-05
61. (s)-(+)-3-benzoyl-alpha-methylbenzeneacetic Acid
62. 161k815
63. A878675
64. Q425440
65. S-(+)-ketoprofen; (s)-ketoprofen; Dexketoprofen
66. W-201922
67. (.alpha.s)-3-benzoyl-.alpha.-methylbenzeneacetic Acid
68. Benzeneacetic Acid, 3-benzoyl-.alpha.-methyl-, (.alpha.s)-
69. Benzeneacetic Acid, 3-benzoyl-.alpha.-methyl-, (s)-
70. Benzeneacetic Acid, 3-benzoyl-?-methyl-, (s)-hydratropic Acid, M-benzoyl-, (+)-
| Molecular Weight | 254.28 g/mol |
|---|---|
| Molecular Formula | C16H14O3 |
| XLogP3 | 3.1 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 4 |
| Exact Mass | 254.094294304 g/mol |
| Monoisotopic Mass | 254.094294304 g/mol |
| Topological Polar Surface Area | 54.4 Ų |
| Heavy Atom Count | 19 |
| Formal Charge | 0 |
| Complexity | 331 |
| 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 | 1 |
For short-term treatment of mild to moderate pain, including dysmenorrhoea, musculoskeletal pain and toothache.
This drug is an isomer of ketoprofen. Dexketoprofen a propionic acid derivative with analgesic, anti-inflammatory, and antipyretic properties.
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.)
M - Musculo-skeletal system
M01 - Antiinflammatory and antirheumatic products
M01A - Antiinflammatory and antirheumatic products, non-steroids
M01AE - Propionic acid derivatives
M01AE17 - Dexketoprofen
M - Musculo-skeletal system
M02 - Topical products for joint and muscular pain
M02A - Topical products for joint and muscular pain
M02AA - Antiinflammatory preparations, non-steroids for topical use
M02AA27 - Dexketoprofen
Absorption
After oral ingestion, the Dexketoprofen onset of action is within 30 minutes. The plasma half-life of Dexketoprofen is about 4-6 hours. The Cmax is about 30 minutes
Route of Elimination
Approximately 70 to 80% of the ingested dose is recovered in the urine during the first 12 hours post-ingestion, mainly as the acyl-conjugated form of the drug.
Volume of Distribution
<0.25 L/kg
Clearance
Mainly cleared via glucuronide conjugation and followed by renal excretion, mainly unchanged.
Dexketoprofen is highly lipophilic, and is metabolized in the liver by glucuronidation. In one study, after oral administration of 25 mg of dexketoprofen to young healthy adults, Tmax was approximately 30 min for a Cmax of 3.7 0.72 mg/l. Dexketoprofen trometamol is metabolized by the hepatic cytochrome P450 enzymes (CYP2C8 and CYP2C9). Dexketoprofen trometamol has a number of metabolites, with hydroxyl derivatives making up the greatest volume. In humans, hydroxylation plays a minor role. Dexketoprofen is primarily conjugated to an acyl-glucuronide
1.65 h
It is a non-steroidal anti-inflammatory drug (NSAID) that reduces prostaglandin synthesis via inhibition of cyclooxygenase pathway (both COX-1 and COX-2) activity.
API SUPPLIERS
Jai Radhe Sales is your partner for all your sourcing needs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34732
Submission : 2020-03-21
Status : Active
Type : II
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-007
Start Marketing Date : 2020-03-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2025-01-14
Registration Number : 20250114-180-I-682-03
Manufacturer Name : Metrochem API Private Limited
Manufacturer Address : Unit-IV, Plot No. 34B, 40B & 60B, JN Pharma City, Thanam Village, Parawada Mandal, Anakapalli District, Andhra Pradesh, 531021, India.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23201
Submission : 2009-09-18
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
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PharmaCompass offers a list of Dexketoprofen Trometamol 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 Dexketoprofen Trometamol manufacturer or Dexketoprofen Trometamol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dexketoprofen Trometamol manufacturer or Dexketoprofen Trometamol supplier.
PharmaCompass also assists you with knowing the Dexketoprofen Trometamol API Price utilized in the formulation of products. Dexketoprofen Trometamol API Price is not always fixed or binding as the Dexketoprofen Trometamol Price is obtained through a variety of data sources. The Dexketoprofen Trometamol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Enantyum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enantyum, including repackagers and relabelers. The FDA regulates Enantyum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enantyum 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 Enantyum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enantyum supplier is an individual or a company that provides Enantyum active pharmaceutical ingredient (API) or Enantyum finished formulations upon request. The Enantyum suppliers may include Enantyum API manufacturers, exporters, distributors and traders.
click here to find a list of Enantyum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Enantyum DMF (Drug Master File) is a document detailing the whole manufacturing process of Enantyum active pharmaceutical ingredient (API) in detail. Different forms of Enantyum DMFs exist exist since differing nations have different regulations, such as Enantyum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enantyum DMF submitted to regulatory agencies in the US is known as a USDMF. Enantyum USDMF includes data on Enantyum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enantyum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Enantyum 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 Enantyum Drug Master File in Korea (Enantyum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Enantyum. The MFDS reviews the Enantyum KDMF as part of the drug registration process and uses the information provided in the Enantyum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Enantyum 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 Enantyum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Enantyum suppliers with KDMF on PharmaCompass.
A Enantyum written confirmation (Enantyum WC) is an official document issued by a regulatory agency to a Enantyum manufacturer, verifying that the manufacturing facility of a Enantyum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Enantyum APIs or Enantyum finished pharmaceutical products to another nation, regulatory agencies frequently require a Enantyum WC (written confirmation) as part of the regulatory process.
click here to find a list of Enantyum 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 Enantyum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Enantyum 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 Enantyum 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 Enantyum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Enantyum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Enantyum suppliers with NDC on PharmaCompass.
Enantyum 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 Enantyum 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 Enantyum GMP manufacturer or Enantyum GMP API supplier for your needs.
A Enantyum CoA (Certificate of Analysis) is a formal document that attests to Enantyum's compliance with Enantyum specifications and serves as a tool for batch-level quality control.
Enantyum CoA mostly includes findings from lab analyses of a specific batch. For each Enantyum 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.
Enantyum may be tested according to a variety of international standards, such as European Pharmacopoeia (Enantyum EP), Enantyum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enantyum USP).
