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Chemistry

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Also known as: 22071-15-4, 2-(3-benzoylphenyl)propanoic acid, Orudis, 2-(3-benzoylphenyl)propionic acid, Actron, Capisten
Molecular Formula
C16H14O3
Molecular Weight
254.28  g/mol
InChI Key
DKYWVDODHFEZIM-UHFFFAOYSA-N
FDA UNII
90Y4QC304K

Ketoprofen
An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.
Ketoprofen is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of ketoprofen is as a Cyclooxygenase Inhibitor.
1 2D Structure

Ketoprofen

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-(3-benzoylphenyl)propanoic acid
2.1.2 InChI
InChI=1S/C16H14O3/c1-11(16(18)19)13-8-5-9-14(10-13)15(17)12-6-3-2-4-7-12/h2-11H,1H3,(H,18,19)
2.1.3 InChI Key
DKYWVDODHFEZIM-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C1=CC(=CC=C1)C(=O)C2=CC=CC=C2)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
90Y4QC304K
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 19,583 Rp

2. 2-(3-benzoylphenyl)propionic Acid

3. Alrheumat

4. Alrheumum

5. Benzoylhydratropic Acid

6. Orudis

7. Profenid

8. Rp 19583

9. Rp, 19,583

10. Rp-19583

11. Rp19583

2.3.2 Depositor-Supplied Synonyms

1. 22071-15-4

2. 2-(3-benzoylphenyl)propanoic Acid

3. Orudis

4. 2-(3-benzoylphenyl)propionic Acid

5. Actron

6. Capisten

7. Oruvail

8. M-benzoylhydratropic Acid

9. Alrheumat

10. Ketoprofene

11. Profenid

12. Aneol

13. 3-benzoylhydratropic Acid

14. Alrheumun

15. Epatec

16. Iso-k

17. Orudis (tn)

18. Rp-19583

19. Ketoprofeno

20. Ketoprophene

21. 2-[3-(phenylcarbonyl)phenyl]propanoic Acid

22. Ketorin

23. Sector

24. (rs)-ketoprofen

25. 2-(m-benzoylphenyl)propionic Acid

26. Actron Ketoprofen

27. Racemic Ketoprofen

28. Benzeneacetic Acid, 3-benzoyl-.alpha.-methyl-

29. 3-benzoyl-alpha-methylbenzeneacetic Acid

30. Ru 4733

31. Ketoprofen (actron)

32. Chebi:6128

33. Chembl571

34. Nsc-758144

35. Propionic Acid, 2-(3-benzoylphenyl)-

36. (s)-ketoprofen;dexketoprofen

37. 19583 Rp

38. Hydratropic Acid, M-benzoyl-

39. L'acide (benzoyl-3-phenyl)-2-propionique

40. Mls000079024

41. Idea-033

42. R.p. 19,583

43. 90y4qc304k

44. Orudis Kt

45. 1189508-77-7

46. 19583rp

47. Ru-4733

48. Kefenid

49. Ketopron

50. Menamin

51. Meprofen

52. Orugesic

53. Oscorel

54. Smr000040181

55. Fastum

56. Ketoprofen 100 Microg/ml In Acetonitrile

57. Lertus

58. Toprec

59. Toprek

60. Dexal

61. Dsstox_cid_771

62. R.p. 19583

63. Racemic-ketoprofen

64. Dsstox_rid_75783

65. Dsstox_gsid_20771

66. Ketoprofenum

67. Rp 19583

68. Ketoprofene [inn-french]

69. Ketoprofenum [inn-latin]

70. Ketoprofeno [inn-spanish]

71. Ketoprofen (+-)

72. (+-)-m-benzoylhydratropic Acid

73. Benzeneacetic Acid, 3-benzoyl-alpha-methyl-

74. Sr-01000075949

75. Rac Ketoprofen

76. Ccris 4508

77. (+-)-3-benzoyl-alpha-methylbenzeneacetic Acid

78. (+/-)-m-benzoylhydratropic Acid

79. (+) Ketoprofen

80. Ncgc00016757-01

81. Ketoprofen ,(s)

82. Acide (benzoyl-3-phenyl)-2-propionique [french]

83. Prestwick_617

84. Einecs 244-759-8

85. 2-[3-(benzoyl)phenyl]propanoic Acid

86. Cas-22071-15-4

87. Mfcd00055790

88. Nexcede

89. Ketoprofen-13c-d3

90. 2-(3-benzoylphenyl)-propionic Acid

91. Hydratropic Acid, M-benzoyl-, (+-)-

92. Acide (benzoyl-3-phenyl)-2-propionique

93. Spectrum_001309

94. Ketoprofen [mi]

95. Opera_id_509

96. Ketoprofen [inn]

97. Ketoprofen [jan]

98. Prestwick0_000219

99. Prestwick1_000219

100. Prestwick2_000219

101. Prestwick3_000219

102. Spectrum2_000956

103. Spectrum3_001479

104. Spectrum4_000028

105. Spectrum5_001254

106. Ketoprofen [usan]

107. M-benzoyl-hydratropic Acid

108. Ketoprofen [vandf]

109. Epitope Id:131783

110. K 1751

111. Ketoprofen [mart.]

112. Schembl2896

113. Ketoprofen [who-dd]

114. (+/-)-ketoprofen

115. Lopac0_000686

116. Oprea1_117113

117. Bspbio_000237

118. Bspbio_003037

119. Kbiogr_000435

120. Kbioss_001789

121. 22161-86-0

122. Mls000028446

123. Mls001201752

124. Mls001306444

125. Mls002548889

126. Mls006011967

127. Bidd:gt0443

128. Divk1c_000598

129. Spectrum1501215

130. Unii-90y4qc304k

131. Spbio_000952

132. Spbio_002158

133. Benzeneacetic Acid, 3-benzoyl-alpha-methyl-, (+-)-

134. Bpbio1_000261

135. Gtpl4795

136. Ketoprofen (jp17/usp/inn)

137. Ketoprofen [green Book]

138. Ketoprofen, >=98% (tlc)

139. Dtxsid6020771

140. Ketoprofen [ep Impurity]

141. Ketoprofen [orange Book]

142. Dkywvdodhfezim-uhfffaoysa-

143. Hms501n20

144. Kbio1_000598

145. Kbio2_001789

146. Kbio2_004357

147. Kbio2_006925

148. Kbio3_002537

149. 2-(3-benzoylphenyl)propanoicacid

150. Ketoprofen [ep Monograph]

151. Ketoprofen [usp Impurity]

152. Ninds_000598

153. Hms1568l19

154. Hms1921b12

155. Hms2089b16

156. Hms2092l19

157. Hms2095l19

158. Hms2234h16

159. Hms3259i05

160. Hms3262i13

161. Hms3372m08

162. Hms3373g09

163. Hms3649n10

164. Hms3655c15

165. Hms3712l19

166. Hms3884k04

167. Ketoprofen [usp Monograph]

168. Pharmakon1600-01501215

169. Bcp23428

170. Hy-b0227

171. 2-(3'-benzoylphenyl)propionic Acid

172. 2-(3-benzoylphenyl) Propionic Acid

173. Alpha(3-benzoylphenyl)propionic Acid

174. Tox21_110594

175. Tox21_200847

176. Tox21_500686

177. (.+/-.)-m-benzoylhydratropic Acid

178. 2-(3-benzoylphenyl) Propionoic Acid

179. Alpha-(m-benzoylphenyl)propionic Acid

180. Bdbm50022271

181. Ccg-39685

182. Nsc758144

183. S1645

184. Stl450995

185. (r)-(-)-ketoprofen-[13c,d3]

186. 2-(3-benzoylphenyl)propanoic Acid #

187. Alpha-(3-benzoylphenyl)propionic Acid

188. Akos007930512

189. Alpha-(m-benzoylphenyl) Propionic Acid

190. Ketoprofen 100 Microg/ml In Methanol

191. Tox21_110594_1

192. Ac-1486

193. Bcp9000810

194. Db01009

195. Ketoprofen [usan:usp:inn:ban:jan]

196. Ks-5031

197. Lp00686

198. Nc00459

199. Nsc 758144

200. Sdccgsbi-0050664.p004

201. Idi1_000598

202. (rs)-2-(3-benzoylphenyl)propanoic Acid

203. Ncgc00015578-02

204. Ncgc00015578-03

205. Ncgc00015578-04

206. Ncgc00015578-05

207. Ncgc00015578-07

208. Ncgc00015578-08

209. Ncgc00015578-10

210. Ncgc00015578-12

211. Ncgc00015578-23

212. Ncgc00094043-01

213. Ncgc00094043-02

214. Ncgc00094043-03

215. Ncgc00094043-04

216. Ncgc00258401-01

217. Ncgc00261371-01

218. Bk166172

219. ((c)i)-ketoprofen-d4(propionic-d4 Acid)

220. 3-benzoyl-.alpha.-methylbenzeneacetic Acid

221. Bcp0726000302

222. Sbi-0050664.p003

223. (+/-)-2-(3-benzoylphenyl)propionic Acid

224. L''acide (benzoyl-3-phenyl)-2-propionique

225. Unm-0000306100

226. Ab00052249

227. Am20060549

228. Eu-0100686

229. Ft-0602834

230. Ft-0670646

231. Ft-0670647

232. K0038

233. Ketoprofen, Meets Usp Testing Specifications

234. Orudis, Profenid, Dexal, Keduril, Ketofen,

235. Sw196784-3

236. Bim-0050664.0001

237. C01716

238. D00132

239. D78110

240. Ketoprofen, Vetranal(tm), Analytical Standard

241. Ab00052249-17

242. Ab00052249-19

243. Ab00052249-20

244. Ab00052249_21

245. Ab00052249_22

246. 071k154

247. A815896

248. Q409192

249. Q-201268

250. Sr-01000075949-1

251. Sr-01000075949-6

252. Sr-01000075949-9

253. (.+/-.)-3-benzoyl-.alpha.-methylbenzeneacetic Acid

254. Brd-a97739905-001-05-9

255. Brd-a97739905-001-15-8

256. Sr-01000075949-18

257. F2173-0960

258. Z1695709452

259. (+/-)-3-benzoyl-.alpha.-methylbenzeneacetic Acid

260. Ketoprofen, British Pharmacopoeia (bp) Reference Standard

261. Ketoprofen, European Pharmacopoeia (ep) Reference Standard

262. Ketoprofen, United States Pharmacopeia (usp) Reference Standard

263. N-fmoc-3-amino-4-(4-tert-butoxy-phenyl)-butyricacid

264. Ketoprofen, Pharmaceutical Secondary Standard; Certified Reference Material

265. 154907-35-4

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 254.28 g/mol
Molecular Formula C16H14O3
XLogP33.1
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count4
Exact Mass254.094294304 g/mol
Monoisotopic Mass254.094294304 g/mol
Topological Polar Surface Area54.4 Ų
Heavy Atom Count19
Formal Charge0
Complexity331
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameKetoprofen
PubMed HealthKetoprofen (By mouth)
Drug ClassesAnalgesic, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelKetoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula:C16H14O3M.W. 254.29It has a pKa of 5.94 in methanol: water (3:1) an...
Active IngredientKetoprofen
Dosage FormCapsule; Capsule, extended release
RouteOral
Strength200mg; 25mg; 150mg; 75mg; 100mg; 50mg
Market StatusPrescription
CompanyActavis Labs Fl; Teva; Dorado Pharma; Mylan

2 of 2  
Drug NameKetoprofen
PubMed HealthKetoprofen (By mouth)
Drug ClassesAnalgesic, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelKetoprofen is a non-steroidal anti-inflammatory drug. The chemical name for ketoprofen is 2-(3-benzoylphenyl)-propionic acid with the following structural formula:C16H14O3M.W. 254.29It has a pKa of 5.94 in methanol: water (3:1) an...
Active IngredientKetoprofen
Dosage FormCapsule; Capsule, extended release
RouteOral
Strength200mg; 25mg; 150mg; 75mg; 100mg; 50mg
Market StatusPrescription
CompanyActavis Labs Fl; Teva; Dorado Pharma; Mylan

4.2 Drug Indication

For symptomatic treatment of acute and chronic rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, primary dysmenorrhea and mild to moderate pain associated with musculotendinous trauma (sprains and strains), postoperative (including dental surgery) or postpartum pain.


FDA Label


Treatment of musculoskeletal and connective tissue pain


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ketoprofen is a nonsteroidal anti-inflammatory agent (NSAIA) with analgesic and antipyretic properties. Ketoprofen has pharmacologic actions similar to those of other prototypical NSAIDs, which inhibit prostaglandin synthesis. Ketoprofen is used to treat rheumatoid arthritis, osteoarthritis, dysmenorrhea, and alleviate moderate pain.


5.2 MeSH Pharmacological Classification

Cyclooxygenase Inhibitors

Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)


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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
KETOPROFEN
5.3.2 FDA UNII
90Y4QC304K
5.3.3 Pharmacological Classes
Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]
5.4 ATC Code

M02AA10

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


M - Musculo-skeletal system

M01 - Antiinflammatory and antirheumatic products

M01A - Antiinflammatory and antirheumatic products, non-steroids

M01AE - Propionic acid derivatives

M01AE03 - Ketoprofen


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

M02AA10 - Ketoprofen


5.5 Absorption, Distribution and Excretion

Absorption

Ketoprofen is rapidly and well-absorbed orally, with peak plasma levels occurring within 0.5 to 2 hours.


Route of Elimination

In a 24 hour period, approximately 80% of an administered dose of ketoprofen is excreted in the urine, primarily as the glucuronide metabolite.


Clearance

Oral-dose cl=6.9 +/- 0.8 L/h [Ketoprofen Immediate-release capsules (4 50 mg)]

Oral-dose cl=6.8 +/- 1.8 L/h [Ketoprofen Extended-release capsules (1 200 mg)]

0.08 L/kg/h

0.7 L/kg/h [alcoholic cirrhosis patients]


5.6 Metabolism/Metabolites

Rapidly and extensively metabolized in the liver, primarily via conjugation to glucuronic acid. No active metabolites have been identified.


Ketoprofen has known human metabolites that include Ketoprofen glucuronide.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

Conventional capsules: 1.1-4 hours

Extended release capsules: 5.4 hours due to delayed absorption (intrinsic clearance is same as conventional capsules)


5.8 Mechanism of Action

The anti-inflammatory effects of ketoprofen are believed to be due to inhibition cylooxygenase-2 (COX-2), an enzyme involved in prostaglandin synthesis via the arachidonic acid pathway. This results in decreased levels of prostaglandins that mediate pain, fever and inflammation. Ketoprofen is a non-specific cyclooxygenase inhibitor and inhibition of COX-1 is thought to confer some of its side effects, such as GI upset and ulceration. Ketoprofen is thought to have anti-bradykinin activity, as well as lysosomal membrane-stabilizing action. Antipyretic effects may be due to action on the hypothalamus, resulting in an increased peripheral blood flow, vasodilation, and subsequent heat dissipation.


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LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUN PHARMACEUTICAL INDUSTRIES LTD","customerCountry":"INDIA","quantity":"900.00","actualQuantity":"900","unit":"KGS","unitRateFc":"85","totalValueFC":"77152.5","currency":"USD","unitRateINR":"7378","date":"28-Jul-2025","totalValueINR":"6640200","totalValueInUsd":"77152.5","indian_port":"JNPT","hs_no":"29420090","bill_no":"3540233","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1101,11 FLOOR, NO.757 RILI ROAD,AUX CENTRAL BUILDING,YINZHOU DISTRICT, 315100 NINGBO CHINA China","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"}]
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31-Jul-2025
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ABOUT THIS PAGE

Looking for 22071-15-4 / Ketoprofen API manufacturers, exporters & distributors?

Ketoprofen manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ketoprofen 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 Ketoprofen manufacturer or Ketoprofen supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ketoprofen manufacturer or Ketoprofen supplier.

PharmaCompass also assists you with knowing the Ketoprofen API Price utilized in the formulation of products. Ketoprofen API Price is not always fixed or binding as the Ketoprofen Price is obtained through a variety of data sources. The Ketoprofen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ketoprofen

Synonyms

22071-15-4, 2-(3-benzoylphenyl)propanoic acid, Orudis, 2-(3-benzoylphenyl)propionic acid, Actron, Capisten

Cas Number

22071-15-4

Unique Ingredient Identifier (UNII)

90Y4QC304K

About Ketoprofen

An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.

Orudis Manufacturers

A Orudis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orudis, including repackagers and relabelers. The FDA regulates Orudis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orudis 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 Orudis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Orudis Suppliers

A Orudis supplier is an individual or a company that provides Orudis active pharmaceutical ingredient (API) or Orudis finished formulations upon request. The Orudis suppliers may include Orudis API manufacturers, exporters, distributors and traders.

click here to find a list of Orudis suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Orudis USDMF

A Orudis DMF (Drug Master File) is a document detailing the whole manufacturing process of Orudis active pharmaceutical ingredient (API) in detail. Different forms of Orudis DMFs exist exist since differing nations have different regulations, such as Orudis USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Orudis DMF submitted to regulatory agencies in the US is known as a USDMF. Orudis USDMF includes data on Orudis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orudis USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Orudis suppliers with USDMF on PharmaCompass.

Orudis JDMF

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 Orudis Drug Master File in Japan (Orudis JDMF) empowers Orudis 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 Orudis JDMF during the approval evaluation for pharmaceutical products. At the time of Orudis 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 Orudis suppliers with JDMF on PharmaCompass.

Orudis KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Orudis Drug Master File in Korea (Orudis KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Orudis. The MFDS reviews the Orudis KDMF as part of the drug registration process and uses the information provided in the Orudis KDMF to evaluate the safety and efficacy of the drug.

After submitting a Orudis 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 Orudis API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Orudis suppliers with KDMF on PharmaCompass.

Orudis CEP

A Orudis CEP of the European Pharmacopoeia monograph is often referred to as a Orudis Certificate of Suitability (COS). The purpose of a Orudis CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orudis EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orudis to their clients by showing that a Orudis CEP has been issued for it. The manufacturer submits a Orudis CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orudis CEP holder for the record. Additionally, the data presented in the Orudis CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orudis DMF.

A Orudis CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orudis 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 Orudis suppliers with CEP (COS) on PharmaCompass.

Orudis WC

A Orudis written confirmation (Orudis WC) is an official document issued by a regulatory agency to a Orudis manufacturer, verifying that the manufacturing facility of a Orudis active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Orudis APIs or Orudis finished pharmaceutical products to another nation, regulatory agencies frequently require a Orudis WC (written confirmation) as part of the regulatory process.

click here to find a list of Orudis suppliers with Written Confirmation (WC) on PharmaCompass.

Orudis NDC

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 Orudis as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Orudis API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Orudis 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Orudis and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orudis NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Orudis suppliers with NDC on PharmaCompass.

Orudis GMP

Orudis 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 Orudis 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 Orudis GMP manufacturer or Orudis GMP API supplier for your needs.

Orudis CoA

A Orudis CoA (Certificate of Analysis) is a formal document that attests to Orudis's compliance with Orudis specifications and serves as a tool for batch-level quality control.

Orudis CoA mostly includes findings from lab analyses of a specific batch. For each Orudis 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.

Orudis may be tested according to a variety of international standards, such as European Pharmacopoeia (Orudis EP), Orudis JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orudis USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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