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Chemistry

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Also known as: 36322-90-4, Feldene, Piroxicamum, Pyroxycam, Roxicam, Piroftal
Molecular Formula
C15H13N3O4S
Molecular Weight
331.3  g/mol
InChI Key
QYSPLQLAKJAUJT-UHFFFAOYSA-N
FDA UNII
13T4O6VMAM

Piroxicam
A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain. Its long half-life enables it to be administered once daily.
Piroxicam is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of piroxicam is as a Cyclooxygenase Inhibitor.
1 2D Structure

Piroxicam

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-hydroxy-2-methyl-1,1-dioxo-N-pyridin-2-yl-16,2-benzothiazine-3-carboxamide
2.1.2 InChI
InChI=1S/C15H13N3O4S/c1-18-13(15(20)17-12-8-4-5-9-16-12)14(19)10-6-2-3-7-11(10)23(18,21)22/h2-9,19H,1H3,(H,16,17,20)
2.1.3 InChI Key
QYSPLQLAKJAUJT-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1C(=C(C2=CC=CC=C2S1(=O)=O)O)C(=O)NC3=CC=CC=N3
2.2 Other Identifiers
2.2.1 UNII
13T4O6VMAM
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cp 16171

2. Cp-16171

3. Cp16171

4. Feldene

2.3.2 Depositor-Supplied Synonyms

1. 36322-90-4

2. Feldene

3. Piroxicamum

4. Pyroxycam

5. Roxicam

6. Piroftal

7. Baxo

8. Cp-16171

9. 2h-1,2-benzothiazine-3-carboxamide, 4-hydroxy-2-methyl-n-2-pyridinyl-, 1,1-dioxide

10. 4-hydroxy-2-methyl-n-(pyridin-2-yl)-2h-benzo[e][1,2]thiazine-3-carboxamide 1,1-dioxide

11. Cp 16171

12. Chf 1251

13. Nsc 666076

14. Piroxicam (feldene)

15. 4-hydroxy-2-methyl-n-(2-pyridyl)-2h-1,2-benzothiazine-3-carboxamide-1,1-dioxide

16. Nsc-666076

17. 13t4o6vmam

18. 4-hydroxy-2-methyl-3-(pyrid-2-yl-carbamoyl)-2h-1,2-benzothiazine 1,1-dioxide

19. 4-hydroxy-2-methyl-n-(2-pyridyl)-2h-1,2-benzothiazin-3-caboxyamid-1,1-dioxid

20. 4-hydroxy-2-methyl-n-2-pyridyl-2h-1,2-benzothiazine-3-carboxamide 1,1-dioxide

21. Cp-16,171

22. Mls000069644

23. Chebi:8249

24. Nsc666076

25. 4-hydroxy-2-methyl-n-pyridin-2-yl-2h-1,2-benzothiazine-3-carboxamide 1,1-dioxide

26. Ncgc00015823-02

27. Artroxicam

28. Bruxicam

29. Caliment

30. Flogobene

31. Geldene

32. Improntal

33. Larapam

34. Piroflex

35. Reudene

36. Roxiden

37. Sasulen

38. Smr000035997

39. Solocalm

40. Erazon

41. Pirkam

42. Piroxicam Usp

43. Riacen

44. Zunden

45. Roxam

46. Cas-36322-90-4

47. Dsstox_cid_1170

48. 4-hydroxy-2-methyl-1,1-dioxo-n-pyridin-2-yl-1lambda6,2-benzothiazine-3-carboxamide

49. 4-hydroxy-2-methyl-n-2-pyridinyl-2h-1,2-benzothiazine-3-carboxamide 1,1-dioxide

50. Dsstox_rid_75990

51. Dsstox_gsid_21170

52. Piroxicamum [inn-latin]

53. Piroxicam D3 (n-methyl D3)

54. Rosiden

55. Felden

56. Feldene Fast

57. Feldene Gel

58. 4-hydroxy-2-methyl-n-(2-pyridyl)-2h-1,2-benzothiazine-3-carboxamide 1,1-dioxide

59. 4-hydroxy-2-methyl-n-2-pyridinyl-2h-1,2-benzothiazine-3-carboxamide-1,1-dioxide

60. (z)-3-(hydroxy(pyridin-2-ylamino)methylene)-2-methyl-2h-benzo[e][1,2]thiazin-4(3h)-one 1,1-dioxide

61. Feldene (tn)

62. Ccris 3719

63. Sr-01000000199

64. Einecs 252-974-3

65. Ak1015

66. Unii-13t4o6vmam

67. Brn 0627692

68. 4-hydroxy-2-methyl-1,1-dioxo-n-pyridin-2-yl-1?^{6},2-benzothiazine-3-carboxamide

69. Piroxicam,(s)

70. Prestwick_573

71. Mfcd00057317

72. 4-hydroxy-2-methyl-n-(2-pyridyl)-2h-1,2-benzothiazin-3-caboxyamid-1,1-dioxid [german]

73. Piroxicam [usan:usp:inn:ban:jan]

74. Piroxicam:malonic Acid

75. Spectrum_001115

76. Tocris-0960

77. Piroxicam-(methyl-d3)

78. Opera_id_442

79. Piroxicam [inn]

80. Piroxicam [jan]

81. Piroxicam: Form Alpha1

82. Piroxicam: Form Alpha2

83. Piroxicam [mi]

84. Piroxicam [usan]

85. Prestwick0_000211

86. Prestwick1_000211

87. Prestwick2_000211

88. Prestwick3_000211

89. Spectrum2_001287

90. Spectrum3_000780

91. Spectrum4_000968

92. Spectrum5_001445

93. Lopac-p-5654

94. Piroxicam [vandf]

95. Piroxicam Anhydrous

96. Chembl527

97. Piroxicam [mart.]

98. P 5654

99. Piroxicam [usp-rs]

100. Piroxicam [who-dd]

101. Bidd:pxr0154

102. Lopac0_000900

103. Oprea1_714707

104. Schembl13462

105. Schembl21350

106. Bspbio_000221

107. Bspbio_001030

108. Bspbio_002460

109. Kbiogr_000370

110. Kbiogr_001315

111. Kbioss_000370

112. Kbioss_001595

113. Mls000038002

114. Mls001148207

115. Mls001304054

116. Mls004774122

117. Divk1c_000369

118. Spectrum1500491

119. Spbio_001293

120. Spbio_002142

121. Piroxicam (jp17/usp/inn)

122. Bpbio1_000245

123. Gtpl7273

124. Piroxicam, >=98% (tlc)

125. Schembl3703617

126. Piroxicam [orange Book]

127. Piroxicam For System Suitability

128. Chembl1518938

129. Dtxsid5021170

130. Piroxicam [ep Monograph]

131. Bcbcmap01_000176

132. Bdbm85245

133. Hms501c11

134. Kbio1_000369

135. Kbio2_000370

136. Kbio2_001595

137. Kbio2_002938

138. Kbio2_004163

139. Kbio2_005506

140. Kbio2_006731

141. Kbio3_000719

142. Kbio3_000720

143. Kbio3_001680

144. Piroxicam [usp Monograph]

145. Ninds_000369

146. Piroxicam 1.0 Mg/ml In Methanol

147. Bio1_000363

148. Bio1_000852

149. Bio1_001341

150. Bio2_000355

151. Bio2_000835

152. Glxc-26155

153. Glxc-26156

154. Hms1362d11

155. Hms1568l03

156. Hms1792d11

157. Hms1920h22

158. Hms1990d11

159. Hms2089b06

160. Hms2092a05

161. Hms2095l03

162. Hms2231g03

163. Hms3262d22

164. Hms3267i03

165. Hms3369b07

166. Hms3403d11

167. Hms3414h17

168. Hms3429l03

169. Hms3655c04

170. Hms3678h15

171. Hms3712l03

172. Hms3884c08

173. Pharmakon1600-01500491

174. Bcp02919

175. Hy-b0253

176. Nsc_4856

177. Tox21_110231

178. Tox21_200151

179. Tox21_500900

180. Ccg-36403

181. Nsc757284

182. S1713

183. Stk177288

184. Zinc12466469

185. Zinc51133897

186. Zinc87724780

187. Akos000714958

188. Akos025312555

189. Akos026749939

190. Tox21_110231_1

191. Am84917

192. Db00554

193. Ks-5322

194. Lp00900

195. Nsc-757284

196. Sdccgsbi-0050875.p005

197. (4-hydroxy-2-methyl-1,1-dioxobenzo[e]1,2-thiazin-3-yl)-n-(2-pyridyl)carboxamid E

198. (4-hydroxy-2-methyl-1,1-dioxobenzo[e]1,2-thiazin-3-yl)-n-(2-pyridyl)carboxamide

199. 2h-1,2-benzothiazine-3-carboxamide,4-hydroxy-2-methyl-n-2-pyridinyl-, 1,1-dioxide

200. 3,4-dihydro-2-methyl-4-oxo-n-2-pyridyl-2h-1,2-benzothiazine-3-carboxamide 1,1-dioxide

201. 4-hydroxy-2-methyl-n-(pyridin-2-yl)-2h-1,2-benzothiazine-3-carboxamide 1,1-dioxide

202. Idi1_000369

203. Idi1_002110

204. Ncgc00015823-01

205. Ncgc00015823-03

206. Ncgc00015823-04

207. Ncgc00015823-05

208. Ncgc00015823-06

209. Ncgc00015823-07

210. Ncgc00015823-08

211. Ncgc00015823-09

212. Ncgc00015823-10

213. Ncgc00015823-11

214. Ncgc00015823-12

215. Ncgc00015823-13

216. Ncgc00015823-14

217. Ncgc00015823-15

218. Ncgc00015823-17

219. Ncgc00015823-18

220. Ncgc00015823-20

221. Ncgc00015823-29

222. Ncgc00021244-03

223. Ncgc00021244-05

224. Ncgc00021244-06

225. Ncgc00021244-07

226. Ncgc00021244-08

227. Ncgc00021244-09

228. Ncgc00188982-01

229. Ncgc00257705-01

230. Ncgc00261585-01

231. Piroxicam 100 Microg/ml In Acetonitrile

232. 1488516-58-0

233. Ac-24190

234. Nci60_022912

235. Bcp0726000299

236. Sbi-0050875.p004

237. Cas_36322-90-4

238. Piroxicam, Meets Usp Testing Specifications

239. Eu-0100900

240. Ft-0630590

241. Ft-0673949

242. P1905

243. Sw219862-1

244. En300-70724

245. A19556

246. C01608

247. D00127

248. D70554

249. Ab00052074-21

250. Ab00052074-22

251. Ab00052074_23

252. Ab00052074_24

253. 322p904

254. Q408676

255. Sr-01000000199-3

256. Sr-01000000199-5

257. Sr-01000000199-9

258. W-106626

259. Sr-01000000199-12

260. F0001-2399

261. Piroxicam, British Pharmacopoeia (bp) Reference Standard

262. Z1259192069

263. Piroxicam, European Pharmacopoeia (ep) Reference Standard

264. Piroxicam, United States Pharmacopeia (usp) Reference Standard

265. Piroxicam, Pharmaceutical Secondary Standard; Certified Reference Material

266. 4-hydroxy-2-methyl-1,1-dioxo-n-(2-pyridyl)-1$l^{6},2-benzothiazine-3-carboxamide

267. 4-hydroxy-2-methyl-1,1-dioxo-n-(pyridin-2-yl)-2h-1$l^{6},2-benzothiazine-3-carboxamide

268. 4-hydroxy-2-methyl-3-(2-pyridylcarbamoyl)-2h-1,2-benzothiazine 1,1-dioxide

269. 4-hydroxy-2-methyl-n-(2-pyridyl)-2h-1,2-benzo-thiazine-3-carboxamide1,1-dioxide

270. 4-hydroxy-2-methyl-n-(pyridin-2-yl)-2h-benzo[e][1,2]thiazine-3-carboxamide1,1-dioxide

271. 4-hydroxy-2-methyl-n-2-pyridinyl-2h-1,2-benzothiazine-3-carboxamide1,1-dioxide

272. N-(2-pyridyl)-4-hydroxy-2-methyl-2h-1,2-benzothiazine-3-carboxamide 1,1-dioxide

273. 1044566-76-8

274. 3-{hydroxy[(pyridin-2-yl)amino]methylidene}-2-methyl-3,4-dihydro-2h-1$l^{6},2-benzothiazine-1,1,4-trione

275. 3-{hydroxy[(pyridin-2-yl)amino]methylidene}-2-methyl-3,4-dihydro-2h-1lambda6,2-benzothiazine-1,1,4-trione

276. 4-hydroxy-2-methyl-1,1-dioxo-n-(2-pyridyl)-1,2-dihydro-1lambda,2-benzothiazine-3-carboxamide

277. 4-hydroxy-2-methyl-n-(2-pyridyl)-2h-1,2-benzothiazine -3-carboxamide-1,1-dioxide Malonic Acid

2.4 Create Date
2011-12-26
3 Chemical and Physical Properties
Molecular Weight 331.3 g/mol
Molecular Formula C15H13N3O4S
XLogP33.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count2
Exact Mass331.06267708 g/mol
Monoisotopic Mass331.06267708 g/mol
Topological Polar Surface Area108 Ų
Heavy Atom Count23
Formal Charge0
Complexity611
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameAkten
PubMed HealthLidocaine (Into the eye)
Drug ClassesAnesthetic, Local
Active IngredientLidocaine hydrochloride
Dosage FormGel
RouteOphthalmic
Strength3.5%
Market StatusPrescription
CompanyAkorn

2 of 6  
Drug NameFeldene
PubMed HealthPiroxicam (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelFELDENEcontains piroxicam which is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each maroon and blue capsule contains 10 mg piroxicam, each maroon capsule contains 20 mg piroxicam for oral administration. The chemica...
Active IngredientPiroxicam
Dosage FormCapsule
RouteOral
Strength10mg; 20mg
Market StatusPrescription
CompanyPfizer

3 of 6  
Drug NamePiroxicam
PubMed HealthPiroxicam (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelPiroxicam capsules USP contain piroxicam which is a member of the oxicam group of non-steroidal anti-inflammatory drugs (NSAIDs). Each dark green and olive capsule contains 10 mg piroxicam, each dark green capsule contains 20 mg piroxicam for oral ad...
Active IngredientPiroxicam
Dosage FormCapsule
RouteOral
Strength10mg; 20mg
Market StatusPrescription
CompanyTeva; Nostrum Labs; Mutual Pharm; Mylan

4 of 6  
Drug NameAkten
PubMed HealthLidocaine (Into the eye)
Drug ClassesAnesthetic, Local
Active IngredientLidocaine hydrochloride
Dosage FormGel
RouteOphthalmic
Strength3.5%
Market StatusPrescription
CompanyAkorn

5 of 6  
Drug NameFeldene
PubMed HealthPiroxicam (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelFELDENEcontains piroxicam which is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each maroon and blue capsule contains 10 mg piroxicam, each maroon capsule contains 20 mg piroxicam for oral administration. The chemica...
Active IngredientPiroxicam
Dosage FormCapsule
RouteOral
Strength10mg; 20mg
Market StatusPrescription
CompanyPfizer

6 of 6  
Drug NamePiroxicam
PubMed HealthPiroxicam (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelPiroxicam capsules USP contain piroxicam which is a member of the oxicam group of non-steroidal anti-inflammatory drugs (NSAIDs). Each dark green and olive capsule contains 10 mg piroxicam, each dark green capsule contains 20 mg piroxicam for oral ad...
Active IngredientPiroxicam
Dosage FormCapsule
RouteOral
Strength10mg; 20mg
Market StatusPrescription
CompanyTeva; Nostrum Labs; Mutual Pharm; Mylan

4.2 Drug Indication

For treatment of osteoarthritis and rheumatoid arthritis.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Piroxicam is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Piroxicam works by reducing hormones that cause inflammation and pain in the body. Piroxicam is used to reduce the pain, inflammation, and stiffness caused by rheumatoid arthritis and osteoarthritis.


5.2 MeSH Pharmacological Classification

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.)


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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
PIROXICAM
5.3.2 FDA UNII
13T4O6VMAM
5.3.3 Pharmacological Classes
Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]
5.4 ATC Code

M01AC01

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

M01AC - Oxicams

M01AC01 - Piroxicam


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

M02AA07 - Piroxicam


S - Sensory organs

S01 - Ophthalmologicals

S01B - Antiinflammatory agents

S01BC - Antiinflammatory agents, non-steroids

S01BC06 - Piroxicam


5.5 Absorption, Distribution and Excretion

Absorption

Well absorbed following oral administration.


Route of Elimination

Piroxicam and its biotransformation products are excreted in urine and feces, with about twice as much appearing in the urine as in the feces. Approximately 5% of a piroxicam dose is excreted unchanged. However, a substantial portion of piroxicam elimination occurs by hepatic metabolism. Piroxicam is excreted into human milk.


Volume of Distribution

0.14 L/kg


5.6 Metabolism/Metabolites

Renal


Piroxicam has known human metabolites that include 5'-Hydroxypiroxicam.

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


5.7 Biological Half-Life

30 to 86 hours


5.8 Mechanism of Action

The antiinflammatory effect of Piroxicam may result from the reversible inhibition of cyclooxygenase, causing the peripheral inhibition of prostaglandin synthesis. The prostaglandins are produced by an enzyme called Cox-1. Piroxicam blocks the Cox-1 enzyme, resulting into the disruption of production of prostaglandins. Piroxicam also inhibits the migration of leukocytes into sites of inflammation and prevents the formation of thromboxane A2, an aggregating agent, by the platelets.


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DOSAGE - CAPSULE;ORAL - 10MG

USFDA APPLICATION NUMBER - 18147

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DOSAGE - CAPSULE;ORAL - 20MG

USFDA APPLICATION NUMBER - 18147

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ABOUT THIS PAGE

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API | Excipient name

Piroxicam

Synonyms

36322-90-4, Feldene, Piroxicamum, Pyroxycam, Roxicam, Piroftal

Cas Number

36322-90-4

Unique Ingredient Identifier (UNII)

13T4O6VMAM

About Piroxicam

A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain. Its long half-life enables it to be administered once daily.

Piroxicam Manufacturers

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

Piroxicam Suppliers

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

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

Piroxicam USDMF

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

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

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

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

Piroxicam KDMF

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

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

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

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

Piroxicam CEP

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

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

Piroxicam WC

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

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

Piroxicam 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 Piroxicam as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Piroxicam 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 Piroxicam 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 Piroxicam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Piroxicam NDC to their finished compounded human drug products, they may choose to do so.

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

Piroxicam GMP

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

Piroxicam CoA

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

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

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