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Synopsis

Synopsis

Chemistry

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Also known as: 169590-42-5, Celebrex, Celebra, Onsenal, Celocoxib, Celecox
Molecular Formula
C17H14F3N3O2S
Molecular Weight
381.4  g/mol
InChI Key
RZEKVGVHFLEQIL-UHFFFAOYSA-N
FDA UNII
JCX84Q7J1L

Celecoxib
A pyrazole derivative and selective CYCLOOXYGENASE 2 INHIBITOR that is used to treat symptoms associated with RHEUMATOID ARTHRITIS; OSTEOARTHRITIS and JUVENILE ARTHRITIS, as well as the management of ACUTE PAIN.
Celecoxib is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of celecoxib is as a Cyclooxygenase Inhibitor.
1 2D Structure

Celecoxib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[5-(4-methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide
2.1.2 InChI
InChI=1S/C17H14F3N3O2S/c1-11-2-4-12(5-3-11)15-10-16(17(18,19)20)22-23(15)13-6-8-14(9-7-13)26(21,24)25/h2-10H,1H3,(H2,21,24,25)
2.1.3 InChI Key
RZEKVGVHFLEQIL-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=CC=C(C=C1)C2=CC(=NN2C3=CC=C(C=C3)S(=O)(=O)N)C(F)(F)F
2.2 Other Identifiers
2.2.1 UNII
JCX84Q7J1L
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-(5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl)benzenesulfonamide

2. Celebrex

3. Sc 58635

4. Sc-58635

5. Sc58635

2.3.2 Depositor-Supplied Synonyms

1. 169590-42-5

2. Celebrex

3. Celebra

4. Onsenal

5. Celocoxib

6. Celecox

7. Sc 58635

8. Sc-58635

9. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl]benzenesulfonamide

10. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide

11. Ym177

12. 184007-95-2

13. Ym 177

14. P-(5-p-tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide

15. Hsdb 7038

16. Mfcd00941298

17. 4-(5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl)benzenesulfonamide

18. Sc58635

19. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl]benzene-1-sulfonamide

20. Chembl118

21. Nsc-719627

22. Nsc-758624

23. Dfn15

24. Jcx84q7j1l

25. Dfn-15

26. 194044-54-7

27. Chebi:41423

28. 4-(5-(p-tolyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl)benzenesulfonamide

29. Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl]-

30. Celecoxib [usan]

31. Ncgc00091455-01

32. Xilebao

33. Dsstox_cid_2777

34. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl]-benzenesulfonamide

35. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonami De

36. Dsstox_rid_76725

37. Dsstox_gsid_22777

38. Solexa

39. Benzenesulfonamide, 4-(5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl)-

40. Celebrex (tn)

41. Smr000550473

42. Cas-169590-42-5

43. Sr-01000837528

44. Ym-177

45. Unii-jcx84q7j1l

46. Celecoxibum

47. Celecoxib [usan:inn:ban]

48. Ccris 9330

49. Tpi-336

50. Celecoxib- Bio-x

51. Celecoxib-[d4]

52. Onsenal (tn)

53. Ai-525

54. Cep-33222

55. Celebcoxib

56. Elyxyb

57. Spectrum_000432

58. 1oq5

59. Celecoxib [inn]

60. Celecoxib [jan]

61. Celecoxib [mi]

62. Celecoxib [hsdb]

63. Spectrum2_001576

64. Spectrum3_001996

65. Spectrum4_000182

66. Spectrum5_001324

67. Celecoxib [vandf]

68. Celecoxib [mart.]

69. Celecoxib [usp-rs]

70. Celecoxib [who-dd]

71. Cid_2662

72. Schembl3708

73. Celecoxib (jan/usp/inn)

74. Bspbio_003596

75. Celecoxib [ema Epar]

76. Kbiogr_000723

77. Kbiogr_002351

78. Kbioss_000912

79. Kbioss_002354

80. Mls001165684

81. Mls001195656

82. Mls001304708

83. Mls006011862

84. Bidd:gt0408

85. Divk1c_000893

86. Spectrum1503678

87. Spbio_001512

88. Gtpl2892

89. Celecoxib [orange Book]

90. Celecoxib [ep Monograph]

91. Celecoxib, >=98% (hplc)

92. Dtxsid0022777

93. Bdbm11639

94. Hms502m15

95. Kbio1_000893

96. Kbio2_000912

97. Kbio2_002351

98. Kbio2_003480

99. Kbio2_004919

100. Kbio2_006048

101. Kbio2_007487

102. Kbio3_002830

103. Kbio3_003037

104. Celecoxib [usp Monograph]

105. Ex-a175

106. Cmap_000027

107. Ninds_000893

108. Bcpp000290

109. Elyxyb (dfn-15; Oral Solution)

110. Hms1922g14

111. Hms2089l18

112. Hms2093i07

113. Hms2234n18

114. Hms3259l08

115. Hms3261a14

116. Hms3373a09

117. Hms3654h09

118. Hms3715f11

119. Hms3867i03

120. Hms3884m07

121. Pharmakon1600-01503678

122. Consensi Component Celecoxib

123. Act02648

124. Albb-033772

125. Bcp02156

126. Zinc2570895

127. Tox21_111135

128. Tox21_201964

129. Tox21_300599

130. Tox21_500406

131. Us8741944, Comparative Compound

132. 4-[5-(p-tolyl)-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide

133. Bbl029086

134. Ccg-39354

135. Nsc719627

136. Nsc758624

137. S1261

138. Stl373576

139. Celecoxib 1.0 Mg/ml In Acetonitrile

140. Akos015842517

141. Celecoxib Component Of Consensi

142. Tox21_111135_1

143. Ac-4228

144. Am84588

145. Bcp9000507

146. Cs-0570

147. Db00482

148. Ks-1041

149. Nc00708

150. Nsc 719627

151. Nsc 758624

152. Sb19318

153. Idi1_000893

154. Celecoxib 100 Microg/ml In Acetonitrile

155. Ncgc00091455-02

156. Ncgc00091455-03

157. Ncgc00091455-04

158. Ncgc00091455-05

159. Ncgc00091455-06

160. Ncgc00091455-07

161. Ncgc00091455-08

162. Ncgc00091455-09

163. Ncgc00091455-13

164. Ncgc00254540-01

165. Ncgc00259513-01

166. Ncgc00261091-01

167. Bc164295

168. Bp-30217

169. Hy-14398

170. Nci60_041049

171. Sy064976

172. Sbi-0051875.p002

173. Unm-0000305813

174. Ft-0601628

175. Ft-0623536

176. Ft-0700357

177. Sw199611-3

178. A25046

179. C07589

180. D00567

181. Ab00052396-07

182. Ab00052396-08

183. Ab00052396-09

184. Ab00052396_10

185. Ab00052396_11

186. 590c425

187. Q408801

188. J-010566

189. J-520011

190. Q-200816

191. Sr-01000837528-2

192. Sr-01000837528-3

193. Brd-k02637541-001-02-4

194. Brd-k02637541-001-06-5

195. Z2210694606

196. Celecoxib, European Pharmacopoeia (ep) Reference Standard

197. Celecoxib, United States Pharmacopeia (usp) Reference Standard

198. 4-[5-(p-tolyl)-3-(trifluoromethyl)-1-pyrazolyl]benzenesulfonamide

199. 4-(5-p-tolyl-3-(trifluoromethyl)-1h-pyrazol-1-yl)benzenesulfonamide

200. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-pyrazol-1-yl]benzenesulfonamide

201. 5-(4-methylphenyl)-1-(4-sulfamoylphenyl)-3-(trifluoromethyl)pyrazole

202. Celecoxib, Pharmaceutical Secondary Standard; Certified Reference Material

203. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyazol-1-yl]benezenesulfonamide

204. Benzenesulfonamide,4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl]-

205. 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-pyrazol-1-yl]benzenesulfonamide;4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1h-pyrazol-1-yl]benzenesulfonamide

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 381.4 g/mol
Molecular Formula C17H14F3N3O2S
XLogP33.4
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count3
Exact Mass381.07588236 g/mol
Monoisotopic Mass381.07588236 g/mol
Topological Polar Surface Area86.4 Ų
Heavy Atom Count26
Formal Charge0
Complexity577
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 4  
Drug NameCelebrex
PubMed HealthCelecoxib (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelCELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chem...
Active IngredientCelecoxib
Dosage FormCapsule
Routeoral; Oral
Strength200mg; 100mg; 50mg; 400mg
Market StatusPrescription
CompanyGd Searle

2 of 4  
Drug NameCelecoxib
PubMed HealthCelecoxib (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelCELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chem...
Active IngredientCelecoxib
Dosage FormCapsule
RouteOral
Strength200mg; 100mg; 50mg; 400mg
Market StatusTentative Approval; Prescription
CompanyWatson Labs; Mylan Pharms; Teva

3 of 4  
Drug NameCelebrex
PubMed HealthCelecoxib (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelCELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chem...
Active IngredientCelecoxib
Dosage FormCapsule
Routeoral; Oral
Strength200mg; 100mg; 50mg; 400mg
Market StatusPrescription
CompanyGd Searle

4 of 4  
Drug NameCelecoxib
PubMed HealthCelecoxib (By mouth)
Drug ClassesAnalgesic, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Drug LabelCELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chem...
Active IngredientCelecoxib
Dosage FormCapsule
RouteOral
Strength200mg; 100mg; 50mg; 400mg
Market StatusTentative Approval; Prescription
CompanyWatson Labs; Mylan Pharms; Teva

4.2 Therapeutic Uses

Cyclooxygenase 2 Inhibitors

National Library of Medicine's Medical Subject Headings. Celecoxib. Online file (MeSH, 2018). Available from, as of January 23, 2018: https://meshb.nlm.nih.gov/search


/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Celecoxib is included in the database.

NIH/NLM; ClinicalTrials.Gov. Available from, as of January 22, 2018: https://clinicaltrials.gov/


/Celebrex is indicated/ for the management of the signs and symptoms of osteoarthritis. /Included in US product labeling/

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


/Celebrex is indicated/ for the management of the signs and symptoms of rheumatoid arthritis. /Included in US product labeling/

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


For more Therapeutic Uses (Complete) data for Celecoxib (14 total), please visit the HSDB record page.


4.3 Drug Warning

/BOXED WARNING/ WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS. Cardiovascular Thrombotic Events: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. Celebrex is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


/BOXED WARNING/ WARNING: RISK OF SERIOUS GASTROINTESTINAL EVENTS. Gastrointestinal Bleeding, Ulceration, and Perforation: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs). Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, celebrex is contraindicated in patients with this form of aspirin sensitivity. When celebrex is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


Celebrex is contraindicated in patients with previous serious skin reactions to nonsteroidal anti-inflammatory drugs (NSAIDs).

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


For more Drug Warnings (Complete) data for Celecoxib (33 total), please visit the HSDB record page.


4.4 Drug Indication

Celecoxib is indicated for symptomatic treatment of adult osteoarthritis (OA) and adult rheumatoid arthritis (RA). Celecoxib is not a substitute for aspirin for cardiovascular event prophylaxis. It may be also be used to treat acute pain from various sources, juvenile rheumatoid arthritis in children over 2, ankylosing spondylitis, and primary dysmenorrhea. Celecoxib, in combination with [tramadol], is indicated for the management of acute pain in adults severe enough to require an opioid analgesic and in whom alternative treatments are inadequate.


Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4. 4).

The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been demonstrated (see sections 4. 4 and 5. 1)


5 Pharmacology and Biochemistry
5.1 Pharmacology

Celecoxib inhibits cyclooxygenase 2 (COX-2) enzyme, reducing pain and inflammation. It is important to note that though the risk of bleeding with celecoxib is lower than with certain other NSAIDS, it exists nonetheless and caution must be observed when it is administered to those with a high risk of gastrointestinal bleeding. **A note on the risk of cardiovascular events** Significant concerns regarding the safety of COX-2 selective NSAIDs emerged in the early 2000s. [Rofecoxib], another member of the COX-2 inhibitor drug class, also known as Vioxx, was withdrawn from the market due to prothrombotic cardiovascular risks. Following an FDA Advisory Committee meeting in 2005, in which data from large clinical outcome trials were evaluated, the FDA concluded that the risk for cardiovascular thrombotic events for both COX-2 selective NSAIDs and nonselective NSAIDs was evident. It was determined that the benefits of celecoxib treatment, however, outweighed the risks. Postmarketing cardiovascular outcomes trial (PRECISION) revealed that the lowest possible dose of celecoxib was similar in cardiovascular safety to moderate strength doses of both naproxen and ibuprofen. Patients who had previous cardiovascular events including acute MI, coronary revascularization, or coronary stent insertion were not evaluated in the trial. It is not advisable to administer NSAIDS to these groups of patients.


5.2 MeSH Pharmacological Classification

Cyclooxygenase 2 Inhibitors

A subclass of cyclooxygenase inhibitors with specificity for CYCLOOXYGENASE-2. (See all compounds classified as Cyclooxygenase 2 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
CELECOXIB
5.3.2 FDA UNII
JCX84Q7J1L
5.3.3 Pharmacological Classes
Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]
5.4 ATC Code

L01XX33


M01AH01

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


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01X - Other antineoplastic agents

L01XX - Other antineoplastic agents

L01XX33 - Celecoxib


M - Musculo-skeletal system

M01 - Antiinflammatory and antirheumatic products

M01A - Antiinflammatory and antirheumatic products, non-steroids

M01AH - Coxibs

M01AH01 - Celecoxib


5.5 Absorption, Distribution and Excretion

Absorption

Celecoxib is absorbed rapidly in the gastrointestinal tract. When a single oral dose of 200 mg was given to healthy research subjects, the peak plasma levels of celecoxib occurred within 3 hours. The Cmax is 705 ng/mL. When multiple doses are given, steady-state concentrations are reached on or before day 5. When taken with a high-fat meal, peak plasma levels are delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%. The AUC of celecoxib has been shown to be significantly lower in patients with chronic renal impairment. A meta-analysis of pharmacokinetic studies has suggested an approximately 40% higher AUC (area under the curve) of celecoxib in black patients compared to Caucasians for unknown reasons.


Route of Elimination

Celecoxib is primarily eliminated by hepatic metabolism with small amounts (<3%) of the unchanged drug found in both the urine and feces. About 57% of an oral dose of celecoxib is excreted in the feces and 27% is found to be excreted into the urine in the form of metabolites. The main metabolite in urine and feces is identified as the carboxylic acid metabolite (73%). The amount of glucuronide in the urine is reported to be low.


Volume of Distribution

The apparent volume of distribution of celecoxib at steady state (Vss/F) is about 429 L, which suggests wide distribution into various tissues. Celecoxib is not preferentially bound to red blood cells. Another resource reports a volume of distribution of 455 166L.


Clearance

Apparent clearance (CL/F), single oral 200 mg dose, healthy subjects = 27.7 L/hr. Clearance may be decreased by about 47% in patients with chronic renal insufficiency, according to a pharmacokinetic study. Studies have not been performed in patients with severe renal impairment.


/MILK/ Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of Celebrex in breast milk. The calculated average daily infant dose was 10-40 ug/kg/day, less than 1% of the weight-based therapeutic dose for a two-year old-child.

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


/MILK/ The aim of this study was to investigate the transfer of celecoxib into human milk. In one group of 3 breastfeeding patients on celecoxib at steady state, milk levels were determined at set intervals over 24 hours. Plasma levels were determined in 2 of their infants, age 17 and 22 months. In a second group of 2 subjects, intravenous lines were placed and a single 200-mg dose of celecoxib was followed by multiple paired plasma and milk samples over 8 hours. The mean milk-to-plasma ratio for celecoxib was 0.23 (95% confidence interval [CI]: 0.15-0.31). The average concentration of celecoxib in milk during the 8-hour dosing interval was 66 ug/L (95% CI: 41-89). The absolute infant dose averaged 9.8 ug/kg/d (95% CI: 6.2-13.4); the mean relative infant dose was 0.30%. Therefore, the average clinical dose transferred to the infant daily would be approximately 0.3% of the weight-adjusted maternal dose. ...

PMID:15479658 Hale TW et al; J Hum Lact 20 (4): 397-403 (2004)


/MILK/ A 40 year old woman who was breastfeeding her 5 month old daughter was admitted to the hospital for surgery. In the postoperative period, she received four doses of celecoxib (100 mg twice/day) in addition to other medications. Starting about 5 hours after her last dose, four milk samples were obtained by hand expression over a 24 hour interval. The elimination half life range was 4.0-6.5 hours. These data suggest that celecoxib would be eliminated from breast milk about 24 hours after the last dose. Although maternal plasma was not obtained, the estimated milk:plasma ratios (based on reported adult plasma levels) were 0.27-0.59. the infant did not resume breastfeeding until 48 hours after the last dose. If she had nursed, the estimated maximum infant dose would have have been about 40 ug/kg/day.

Briggs, G.G., Freeman, R.K., Yaffee, S.J.; Drugs in Pregancy and Lactation Tenth Edition. Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA. 2015, p. 234


/MILK/ /The aim of this study was/ to determine the milk-to-plasma (M/P) concentration ratio of celecoxib, and estimate likely infant exposure. Blood and milk were sampled for 48 hr after oral administration of celecoxib 200 mg to six lactating volunteers. The M/P ratio was derived from the area under the concentration-time curves (0-infinity) and the infant 'dose' estimated from celecoxib concentrations in milk. The median (range) M/P ratio was 0.18 (0.15-0.26). The median (range) infant 'dose' was 0.23% (0.17-0.30%) of the maternal dose, adjusted for weight. ...

PMID:16390357 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884977 Gardiner SJ et al; Br J Clin Pharmacol 61 (1): 101-4 (2006)


For more Absorption, Distribution and Excretion (Complete) data for Celecoxib (11 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

A large part of celecoxib metabolism is mediated by cytochrome P450 2C9 in the liver with some contribution from CYP3A4 and CYP2C8 and possible contributions from CYP2D6. It is metabolized by biotransformation to carboxylic acid and glucuronide metabolites. Three metabolites, a primary alcohol, a carboxylic acid, and a glucuronide conjugate, have been found in human plasma after celecoxib administration. These are considered inactive metabolites in regards to COX enzyme inhibition. Patients who are known or suspected to have decreased cytochrome P450 2C9 activity or function, based on their previous history, should be administered celecoxib with caution as they may have abnormally high serum concentrations resulting from decreased metabolism celecoxib.


Celecoxib metabolism is primarily mediated via CYP2C9. Three metabolites, a primary alcohol, the corresponding carboxylic acid and its glucuronide conjugate, have been identified in human plasma. These metabolites are inactive as COX-1 or COX-2 inhibitors.

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


Celecoxib has known human metabolites that include Hydroxy celecoxib.

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


5.7 Biological Half-Life

The effective half-life of celecoxib is approximately 11 hours when a single 200 mg dose is given to healthy subjects. The terminal half-life of celecoxib varies because of its low solubility, which prolongs absorption.


A 40 year old woman who was breastfeeding her 5 month old daughter was admitted to the hospital for surgery. In the postoperative period, she received four doses of celecoxib (100 mg twice/day) in addition to other medications. Starting about 5 hours after her last dose, four milk samples were obtained by hand expression over a 24 hour interval. The elimination half life range was 4.0-6.5 hours. ...

Briggs, G.G., Freeman, R.K., Yaffee, S.J.; Drugs in Pregancy and Lactation Tenth Edition. Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA. 2015, p. 234


The plasma elimination half-life of celecoxib following oral administration of a single 200-mg dose under fasting conditions is about 11 hours, and the apparent plasma clearance of the drug is about 500 mL/minute; these parameters exhibit wide intraindividual variability, presumably because the low aqueous solubility of celecoxib prolongs absorption. The half-life of celecoxib is prolonged in patients with renal or hepatic impairment and has been reported to be 13.1 hours in patients with chronic renal insufficiency and 11 or 13.1 hours in patients with mild or moderate hepatic impairment, respectively.

American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 2151


5.8 Mechanism of Action

Unlike most NSAIDs, which inhibit both types of cyclooxygenases (COX-1 and COX-2), celecoxib is a selective noncompetitive inhibitor of cyclooxygenase-2 (COX-2) enzyme. COX-2 is expressed heavily in inflamed tissues where it is induced by inflammatory mediators. The inhibition of this enzyme reduces the synthesis of metabolites that include prostaglandin E2 (PGE2), prostacyclin (PGI2), thromboxane (TXA2), prostaglandin D2 (PGD2), and prostaglandin F2 (PGF2). Resultant inhibition of these mediators leads to the alleviation of pain and inflammation. By inhibiting prostaglandin synthesis, non-steroidal anti-inflammatory drugs (NSAIDs) cause mucosal damage, ulceration and ulcer complication throughout the gastrointestinal tract. Celecoxib poses less of an ulceration risk than other NSAIDS, owing to its decreased effect on gastric mucosal prostaglandin synthesis when compared to placebo. Celecoxib exerts anticancer effects by binding to the cadherin-11 (CDH11)protein, which is thought to be involved in the progression of tumors, and inhibiting the 3-phosphoinositide-dependent kinase-1 (PDK-1) signaling mechanism. In addition, celecoxib has been found to inhibit carbonic anhydrase enzymes 2 and 3, further enhancing its anticancer effects. As mentioned in the pharmacodynamics section of this drug entry, celecoxib may cause an increased risk of thrombotic events. The risk of thrombosis resulting from COX-2 inhibition is caused by the vasoconstricting actions of thromboxane A2, leading to enhanced platelet aggregation, which is uncontrolled when the actions of prostacyclin, a platelet aggregation inhibitor, are suppressed through the inhibition of COX-2.


Nonsteroidal anti-inflammatory drugs (NSAIDs) are well-known causes of acute renal insufficiency and gastropathy in patients with chronic inflammatory diseases. This action is presumed to result from nonselective inhibition of both constitutive and inducible forms of prostaglandin H synthases, also known as the cyclooxygenase enzymes (i.e., COX-1 amd COX-2). Celecoxib (Celebrex) is a COX-2 enzyme inhibitor and has emerged as a preferred therapeutic agent for the treatment of rheumatoid arthritis as compared to other NSAIDs. Celecoxib has recently been the subject of criticism for its side effects, mainly arterial thrombosis and renal hemorrhage, although it is considered a superior drug in protecting the gastrointestinal tract. In the present study, we report that celecoxib not only inhibited COX-2, but also exhibited the property of inhibiting adenylyl cyclase, an important enzyme forming the intracellular second messenger 3',5'-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). Celecoxib also inhibited cholera toxin-stimulated cAMP formation, which indicated its ability to permeate cell membranes in order to reach intracellular adenylyl cyclase. It inhibited in vitro adenylyl cyclase activity in both human colonic epithelial cells and purified adenylyl cyclase from Bordetella pertussis. The IC50 of celecoxib for B. pertussis adenylyl cyclase was calculated to be 0.375 mM. Lineweaver-Burk analysis showed that the type of enzyme inhibition was competitive. The apparent Km and Vm of adenylyl cyclase was calculated as 25.0 nM and 7.14 nmol/min/mg, respectively. Celecoxib changed the Km value to 66.6 nM without affecting the Vmax. The current study suggests that apart from inflammation, celecoxib therapy could be further extended to diseases involving cAMP upregulation either by endogenous reactions or exogenous agents. These new data showing inhibition of adenylyl cyclase should be considered in light of the drug's pathological effects or in patients specifically excluded from treatment (e.g., asthmatics).

PMID:12797547 Saini SS et al; Inflammation 27 (2): 79-88 (2003)


Cardiovascular disease is one of the leading causes of death worldwide, and evidence indicates a correlation between the inflammatory process and cardiac dysfunction. Selective inhibitors of cyclooxygenase-2 (COX-2) enzyme are not recommended for long-term use because of potentially severe side effects to the heart. Considering this and the frequent prescribing of commercial celecoxib, the present study analyzed cellular and molecular effects of 1 and 10 uM celecoxib in a cell culture model. After a 24-hr incubation, celecoxib reduced cell viability in a dose-dependent manner as also demonstrated in MTT assays. Furthermore, reverse transcription-polymerase chain reaction analysis showed that the drug modulated the expression level of genes related to death pathways, and Western blot analyses demonstrated a modulatory effect of the drug on COX-2 protein levels in cardiac cells. In addition, the results demonstrated a downregulation of prostaglandin E2 production by the cardiac cells incubated with celecoxib, in a dose-specific manner. These results are consistent with the decrease in cell viability and the presence of necrotic processes shown by Fourier transform infrared analysis, suggesting a direct correlation of prostanoids in cellular homeostasis and survival.

PMID:24519091 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3932973 Sakane KK et al; Braz J Med Biol Res 47 (1): 50-9 (2014)


Celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, has recently been shown to affect the development of different types of cancer. The present study utilized a murine H22 hepatocarcinoma model to investigate the molecular mechanisms involved in celecoxib-induced inhibition of tumor angiogenesis. Tumor-bearing mice were randomly divided into five groups: i) control; ii) low-dose celecoxib (50 mg/kg); iii) high-dose celecoxib (200 mg/kg); iv) 5-fluorouracil (5-FU), (20 mg/kg) and v) combination of 5-FU and celecoxib (50 mg/kg). The antitumor effect of celecoxib was determined by measuring tumor volume. Tumor angiogenesis was evaluated by microvessel density (MVD). Tumor histology and immunostaining for CD34 in endothelial cells were performed to detect MVD. The expression levels of phosphatase and tensin homologue deleted from chromosome 10 (PTEN), phosphatidylinositol 3-kinase (PI3K), phospho-Akt (P-Akt), COX-2, hypoxia-inducible factor-1a (HIF-1a) and vascular endothelial growth factor-A (VEGF-A) were detected by ELISA, immunohistochemistry and western blotting, respectively. We discovered substantial growth delay in murine H22 hepatoma as a result of celecoxib treatment. The inhibition rate of tumor growth induced by high-dose and low-dose celecoxib was 49.3 and 37.0%, respectively (P<0.05). The expression of PI3K, P-Akt, COX-2, HIF-1a, VEGF-A and PTEN in tumor tissues treated with celecoxib was demonstrated by immunohistochemistry, and the MVD was decreased in a dose-dependent manner (P<0.05). Reduced PI3K and P-Akt was particularly apparent in the high-dose celecoxib group (P<0.05). ELISA and western blotting data showed that the expression of PI3K, P-Akt, COX-2, HIF-1a and VEGF-A were reduced and PTEN was increased after treatment with celecoxib. In conclusion, the impact of celecoxib-induced tumor growth delay of murine H22 hepatocarcinoma may correlate with the inhibition of angiogenesis by reducing PI3K, P-Akt, COX-2, HIF-1a and VEGF-A expression and increasing PTEN expression in tumor tissue.

PMID:24647425 Sui W et al; Oncol Rep 31 (5): 2252-60 (2014)


The mechanism of action of Celebrex is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2).

NIH; DailyMed. Current Medication Information for Celebrex (Celecoxib Capsule) (Updated: October 6, 2017). Available from, as of January 24, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8d52185d-421f-4e34-8db7-f7676db2a226


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Valid Till : 2025-08-08

Written Confirmation Number : WC-0066

Address of the Firm : Plot No 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram, Anakapalli -531081, A...

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Hikal

India
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Hikal

India
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Celecoxib USP/Ph. Eur

Date of Issue : 2022-06-14

Valid Till : 2025-07-02

Written Confirmation Number : WC-0094nA2A

Address of the Firm : Plot No. 72 & 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bengaluru-560 1...

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09

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Celecoxib USP/EP

Date of Issue : 2025-11-12

Valid Till : 2028-11-10

Written Confirmation Number : WC-0079

Address of the Firm : Plot No. - 2209, G.I.D.C., Sarigam - 396 155, Dist - Valsad, Gujarat, India

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10

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Celecoxib USP/Ph. Eur

Date of Issue : 2025-09-29

Valid Till : 2028-08-04

Written Confirmation Number : WC-0127

Address of the Firm : A1/B, SIPCOT Industrial Complex,\r\nKudikadu, Cuddalore -607005, Tamil Nadu, Ind...

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KDMF

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01

Axplora

Germany
  • fda
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  • WHO-GMP

Virtual BoothAxplora is your partner of choice for complex APIs.

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Celecoxib

Registrant Name : Eltech Pharmachem Co., Ltd.

Registration Date : 2025-08-05

Registration Number : 20200915-209-J-721(A)

Manufacturer Name : PharmaZell (India) Private L...

Manufacturer Address : Plot No. 115, Visakha Pharmacity Limited, SEZ, Parawada, Anakapalli – 531 019 Andhr...

Axplora CB

02

Axplora

Germany
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora is your partner of choice for complex APIs.

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Celecoxib

Registrant Name : Sam-O Pharmaceutical Co., Ltd.

Registration Date : 2020-09-15

Registration Number : 20200915-209-J-721

Manufacturer Name : PharmaZell (India) Private L...

Manufacturer Address : Plot No. 115, Visakha Pharmacity Limited, SEZ, Parawada, Anakapalli – 531 019 Andhr...

Axplora CB

03

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Celecoxib

Registrant Name : Iksoo Pharmaceutical Co., Ltd.

Registration Date : 2025-07-14

Registration Number : 20200813-209-J-567(A)

Manufacturer Name : Aurore Pharmaceuticals Priva...

Manufacturer Address : Plot No. 35, 36, 38 To 40 & 49 To 51, Phase-IV, IDA Jeedimetla, Hyderabad, Telangana,...

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Celecoxib

Registrant Name : Donghu Pharma Co., Ltd.

Registration Date : 2026-05-15

Registration Number : 20190812-209-J-405(16)

Manufacturer Name : Jiangxi Synergy Pharmaceutic...

Manufacturer Address : 699, Changle Ave, Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province,...

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Celecoxib

Registrant Name : Narsha Farm Co., Ltd.

Registration Date : 2026-04-14

Registration Number : 20190812-209-J-405(15)

Manufacturer Name : Jiangxi Synergy Pharmaceutic...

Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, China

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Celecoxib

Registrant Name : Taewang Mulsan Co., Ltd.

Registration Date : 2025-06-02

Registration Number : 20190812-209-J-405(14)

Manufacturer Name : Jiangxi Synergy Pharmaceutic...

Manufacturer Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, China

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Celecoxib

Registrant Name : Sampung Pharmachem Co., Ltd.

Registration Date : 2025-10-10

Registration Number : 20251010-209-J-2036

Manufacturer Name : Shandong Anxin Pharmaceutica...

Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shangdong, 250105 China

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Celecoxib

Registrant Name : Gapi Bio Co., Ltd.

Registration Date : 2025-10-29

Registration Number : 20251029-209-J-2046

Manufacturer Name : Zhejiang Chemsyn Pharm Co., ...

Manufacturer Address : No.36 Huayang Road, Hi-Tech Industry Zone, Quzhou City, Zhejiang Province, 324004 PR ...

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Celecoxib

Registrant Name : Ikemi Korea Co., Ltd.

Registration Date : 2025-08-05

Registration Number : 20250805-209-J-1991

Manufacturer Name : Harway Pharma Co., Ltd.

Manufacturer Address : No. 69 Yinhai'er Road, Binhai New Area, Lijin County, Dongying City, Shandong Provinc...

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Celecoxib

Registrant Name : Huseong Bio Co., Ltd.

Registration Date : 2026-05-18

Registration Number : 20260518-209-J-2185

Manufacturer Name : Chemeca Drugs Private Limite...

Manufacturer Address : Plot No.07,Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Anakapalli Di...

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NDC API

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CELECOXIB

NDC Package Code : 62704-0046

Start Marketing Date : 1999-12-31

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CELECOXIB

NDC Package Code : 65862-793

Start Marketing Date : 2023-11-02

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

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CELECOXIB

NDC Package Code : 77777-115

Start Marketing Date : 2021-12-17

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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CELECOXIB

NDC Package Code : 66651-919

Start Marketing Date : 2017-07-24

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CELECOXIB

NDC Package Code : 52048-1995

Start Marketing Date : 2011-01-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CELECOXIB

NDC Package Code : 42571-155

Start Marketing Date : 2010-11-26

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (10kg/10kg)

Marketing Category : BULK INGREDIENT

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CELECOXIB

NDC Package Code : 51927-0319

Start Marketing Date : 2023-10-17

End Marketing Date : 2026-07-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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CELECOXIB

NDC Package Code : 57582-032

Start Marketing Date : 2020-12-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : DRUG FOR FURTHER PROCESSING

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Listed Suppliers

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01

Axplora

Germany
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora is your partner of choice for complex APIs.

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Celecoxib

About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.
Axplora CB

02

Interquim SA

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Celecoxib

About the Company : Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are ...

Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are exported to regulated markets. Approved by regulators and clients, Interquim supports clients from development to marketing with advanced production and quality-control labs. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Interquim

03

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Celecoxib

About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
LGM Pharma CB

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Celecoxib

About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...

Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, impurities, metabolites, method development, advanced intermediates, and APIs for commercial launch. Focused on quality, reliability, and transparency, Nuray is a trusted partner in the global generic market. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Nuray Chemicals

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Celecoxib

About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...

Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered in Hauppauge, New York, it operates 16 offices worldwide. Rochem’s operations are fully cGMP compliant and have been audited by the USFDA and several multinational organizations. The company also trains and audits its partners to ensure FDA-compliant technologies and systems. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Rochem

06

Temad Co

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTemad- We think of world-class quality.

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Celecoxib

About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...

Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Iranian GMP and international standards like ISO 9001/14001/17025/45001 and OHSAS 18001. Temad manufactures over 115 pharmaceutical products, meeting GMP and WHO standards, and exports to 45 countries worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Temad

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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Celecoxib

About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...

Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology products. The company is supported by a dedicated team and promoters with over 25 years of experience in manufacturing, product promotion, and regulatory audits across markets including the EU, Mexico, China, Korea, and Russia. Gonane Pharma is also engaged with Japanese customers and continues to expand into new markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Gonane Pharma

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Digital Content Digital Content

Celecoxib

About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Jai Radhe Sales

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

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Digital Content Digital Content

Celecoxib

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished Formulation Technology Transfer. With 24 years' expertise, our 6 GMP workshops ensure 100-ton monthly cGMP-compliant capacity. We hold 21 NMPA-registered APIs, 4 US-DMF filings, 8 CEP applications, and passed US FDA, Korea MFDS, and global client audits. Note: Patent-protected products are for R&D use only per Patent Act, not for commercial sale.
Shandong Chenghui Shuangda Pharmaceutical

10

HRV Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Digital Content Digital Content

Celecoxib

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
HRV Global Life Sciences
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Drugs in Development

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Details:

BDSI intends to launch ELYXYB in the first quarter of 2022. Additionally, BDSI plans to conduct an ELYXYB pediatric study, which will have the potential to address the significant unmet needs of pediatric and adolescent patients suffering from migraine attacks.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Neurology Brand Name: Elyxyb

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: BioDelivery Sciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition September 09, 2021

Dr Reddy Company Banner

01

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : BioDelivery Sciences

Deal Size : Undisclosed

Deal Type : Acquisition

Details : BDSI intends to launch ELYXYB in the first quarter of 2022. Additionally, BDSI plans to conduct an ELYXYB pediatric study, which will have the potential to address the significant unmet needs of pediatric and adolescent patients suffering from migraine a...

Product Name : Elyxyb

Product Type : Miscellaneous

Upfront Cash : Undisclosed

September 09, 2021

Dr Reddy Company Banner

Details:

ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Neurology Brand Name: Elyxyb

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: BioDelivery Sciences

Deal Size: $15.0 million Upfront Cash: $6.0 million

Deal Type: Acquisition August 04, 2021

Dr Reddy Company Banner

02

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : BioDelivery Sciences

Deal Size : $15.0 million

Deal Type : Acquisition

Details : ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption.

Product Name : Elyxyb

Product Type : Miscellaneous

Upfront Cash : $6.0 million

August 04, 2021

Dr Reddy Company Banner

Details:

Ethypharm has acquired the exclusive rights for the development, registration and commercialization in the top 5 European markets of a novel celecoxib formulation already approved in the US for the acute treatment of migraine. Celecoxib is developed by Dr Reddy's.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Neurology Brand Name: Elyxyb

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Ethypharm

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition May 19, 2021

Dr Reddy Company Banner

03

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Ethypharm

Deal Size : Undisclosed

Deal Type : Acquisition

Details : Ethypharm has acquired the exclusive rights for the development, registration and commercialization in the top 5 European markets of a novel celecoxib formulation already approved in the US for the acute treatment of migraine. Celecoxib is developed by D...

Product Name : Elyxyb

Product Type : Miscellaneous

Upfront Cash : Undisclosed

May 19, 2021

Dr Reddy Company Banner

Details:

Celecoxib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Acute Pain.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 13, 2018

Dr Reddy Company Banner

04

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Celecoxib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Acute Pain.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 13, 2018

Dr Reddy Company Banner

Details:

DFN-15 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Migraine Disorders.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 14, 2017

Dr Reddy Company Banner

05

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : DFN-15 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Migraine Disorders.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 14, 2017

Dr Reddy Company Banner

Details:

DFN-15 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 14, 2017

Dr Reddy Company Banner

06

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Undisclosed

Highest Development Status : Phase I

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : DFN-15 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 14, 2017

Dr Reddy Company Banner

Details:

DFN-15 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Migraine Disorders.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 15, 2015

Dr Reddy Company Banner

07

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Neurology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : DFN-15 is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Migraine Disorders.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 15, 2015

Dr Reddy Company Banner

Details:

Celebrex-Generic (celecoxib) is a COX-2 inhibitor, small molecule drug candidate. It is indicated for the treatment of osteoarthritis & rheumatoid arthritis in adults.


Lead Product(s): Celecoxib,Inapplicable

Therapeutic Area: Musculoskeletal Brand Name: Celebrex-Generic

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 30, 2025

Strides Pharma Science

08

Lead Product(s) : Celecoxib,Inapplicable

Therapeutic Area : Musculoskeletal

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Celebrex-Generic (celecoxib) is a COX-2 inhibitor, small molecule drug candidate. It is indicated for the treatment of osteoarthritis & rheumatoid arthritis in adults.

Product Name : Celebrex-Generic

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 30, 2025

Strides Pharma Science
  • Development Update

Details:

Celecoxib is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of orthodontic pain.


Lead Product(s): Celecoxib,Etoricoxib

Therapeutic Area: Dental and Oral Health Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 30, 2026

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09

Sharif Medical Research Center

Country
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Sharif Medical Research Center

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Details : Celecoxib is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of orthodontic pain.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 30, 2026

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  • Development Update

Details:

HRS-2129 is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of osteoarthritis, knee.


Lead Product(s): HRS-2129,Celecoxib

Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 20, 2026

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10

Shandong Suncadia Medicine Co., Ltd.

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Shandong Suncadia Medicine Co., Ltd.

Country
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Not Confirmed

Details : HRS-2129 is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of osteoarthritis, knee.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 20, 2026

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 100MG

USFDA APPLICATION NUMBER - 20998

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DOSAGE - CAPSULE;ORAL - 200MG

USFDA APPLICATION NUMBER - 20998

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DOSAGE - CAPSULE;ORAL - 400MG

USFDA APPLICATION NUMBER - 20998

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DOSAGE - CAPSULE;ORAL - 50MG

USFDA APPLICATION NUMBER - 20998

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DOSAGE - TABLET;ORAL - EQ 10MG BASE;200MG

USFDA APPLICATION NUMBER - 210045

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DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;200MG

USFDA APPLICATION NUMBER - 210045

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DOSAGE - TABLET;ORAL - EQ 5MG BASE;200MG

USFDA APPLICATION NUMBER - 210045

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Excipients by Applications

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Fillers, Diluents & Binders

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

Grade : Oral

Category : Co-Processed Excipients, Fillers, Diluents & Binders

02

  • fda
  • EDQM
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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Fillers, Diluents & Binders

Brand Name : KoVidone® K25

Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

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06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Grade : Parenteral

Category : Parenteral

Brand Name : Lactose Monohydrate

Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

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07

Pfanstiehl

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.

Grade : Oral

Category : Fillers, Diluents & Binders, Solubilizers

Brand Name : PVP K 30

Excipient Details : PVP K30 is used as a binder, solubilizer, film-forming agent, and stabilizer in pharmaceutical formulations.

Pharmacopoeia Ref : Not Available

Technical Specs : Not Available

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10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Fillers, Diluents & Binders

Brand Name : KoVidone® K30

Excipient Details : KoVidone® K30 is used as a binder for tablets and capsules.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

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Disintegrants & Superdisintegrants

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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCerata Pharmaceuticals LLP: WHO-GMP Certified Leading Manufacturer & Exporter of Steroid-Hormone & Peptide APIs From India.

Grade : Oral

Category : Disintegrants & Superdisintegrants

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

Brand Name : PolyKoVidone XL

Excipient Details : PolyKoVidone XL is used as a superdisintegrant and solid dispersant aid in solid dosage forms such as tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

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07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBoai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Grade : Oral (Pharma Grade)

Category : Disintegrants & Superdisintegrants

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Direct Compression

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07

SPI Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Direct Compression

08

SPI Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Direct Compression, Disintegrants & Superdisintegrants

Brand Name : Mannogem 2080

Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.

Pharmacopoeia Ref : NA

Technical Specs : Not Available

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Granulation

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Lubricants & Glidants

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

Grade : Oral

Category : Lubricants & Glidants

Brand Name : Lubriorb

Excipient Details : Lubriorb is used as a lubricant in oral dosage forms such as tablets.

Pharmacopoeia Ref : USP-NF,BP,EP

Technical Specs : NA

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02

Minakem

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

Grade : Oral

Category : Lubricants & Glidants

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

Grade : Oral

Category : Lubricants & Glidants

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPanvo Organics: Advancing quality APIs and formulations with Halal, Kosher, US FDA, and WHO-approved manufacturing excellence.

Grade : Oral

Category : Lubricants & Glidants

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDr. Paul Lohmann® provides premium mineral salts backed by 140+ years of innovation, quality manufacturing, and global expertise.

Grade : Oral

Category : Lubricants & Glidants

Brand Name : Magnesium Stearate

Excipient Details : Magnesium stearate is used as a lubricant in various oral solid dosage forms.

Pharmacopoeia Ref : Ph. Eur.|USP|NF

Technical Specs : Not Available

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Chewable & Orodispersible Aids

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Solubilizers

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ABOUT THIS PAGE

Looking for 169590-42-5 / Celecoxib API manufacturers, exporters & distributors?

Celecoxib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Celecoxib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Celecoxib manufacturer or Celecoxib supplier for your needs.

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

API | Excipient name

Celecoxib

Synonyms

169590-42-5, Celebrex, Celebra, Onsenal, Celocoxib, Celecox

Cas Number

169590-42-5

Unique Ingredient Identifier (UNII)

JCX84Q7J1L

About Celecoxib

A pyrazole derivative and selective CYCLOOXYGENASE 2 INHIBITOR that is used to treat symptoms associated with RHEUMATOID ARTHRITIS; OSTEOARTHRITIS and JUVENILE ARTHRITIS, as well as the management of ACUTE PAIN.

TPI-336 Manufacturers

A TPI-336 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TPI-336, including repackagers and relabelers. The FDA regulates TPI-336 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TPI-336 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 TPI-336 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

TPI-336 Suppliers

A TPI-336 supplier is an individual or a company that provides TPI-336 active pharmaceutical ingredient (API) or TPI-336 finished formulations upon request. The TPI-336 suppliers may include TPI-336 API manufacturers, exporters, distributors and traders.

click here to find a list of TPI-336 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

TPI-336 USDMF

A TPI-336 DMF (Drug Master File) is a document detailing the whole manufacturing process of TPI-336 active pharmaceutical ingredient (API) in detail. Different forms of TPI-336 DMFs exist exist since differing nations have different regulations, such as TPI-336 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A TPI-336 DMF submitted to regulatory agencies in the US is known as a USDMF. TPI-336 USDMF includes data on TPI-336's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TPI-336 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of TPI-336 suppliers with USDMF on PharmaCompass.

TPI-336 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 TPI-336 Drug Master File in Japan (TPI-336 JDMF) empowers TPI-336 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 TPI-336 JDMF during the approval evaluation for pharmaceutical products. At the time of TPI-336 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 TPI-336 suppliers with JDMF on PharmaCompass.

TPI-336 KDMF

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

Pharmaceutical companies submit a TPI-336 Drug Master File in Korea (TPI-336 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TPI-336. The MFDS reviews the TPI-336 KDMF as part of the drug registration process and uses the information provided in the TPI-336 KDMF to evaluate the safety and efficacy of the drug.

After submitting a TPI-336 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 TPI-336 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of TPI-336 suppliers with KDMF on PharmaCompass.

TPI-336 CEP

A TPI-336 CEP of the European Pharmacopoeia monograph is often referred to as a TPI-336 Certificate of Suitability (COS). The purpose of a TPI-336 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of TPI-336 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of TPI-336 to their clients by showing that a TPI-336 CEP has been issued for it. The manufacturer submits a TPI-336 CEP (COS) as part of the market authorization procedure, and it takes on the role of a TPI-336 CEP holder for the record. Additionally, the data presented in the TPI-336 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the TPI-336 DMF.

A TPI-336 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. TPI-336 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 TPI-336 suppliers with CEP (COS) on PharmaCompass.

TPI-336 WC

A TPI-336 written confirmation (TPI-336 WC) is an official document issued by a regulatory agency to a TPI-336 manufacturer, verifying that the manufacturing facility of a TPI-336 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TPI-336 APIs or TPI-336 finished pharmaceutical products to another nation, regulatory agencies frequently require a TPI-336 WC (written confirmation) as part of the regulatory process.

click here to find a list of TPI-336 suppliers with Written Confirmation (WC) on PharmaCompass.

TPI-336 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 TPI-336 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for TPI-336 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 TPI-336 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 TPI-336 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TPI-336 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of TPI-336 suppliers with NDC on PharmaCompass.

TPI-336 GMP

TPI-336 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 TPI-336 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right TPI-336 GMP manufacturer or TPI-336 GMP API supplier for your needs.

TPI-336 CoA

A TPI-336 CoA (Certificate of Analysis) is a formal document that attests to TPI-336's compliance with TPI-336 specifications and serves as a tool for batch-level quality control.

TPI-336 CoA mostly includes findings from lab analyses of a specific batch. For each TPI-336 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.

TPI-336 may be tested according to a variety of international standards, such as European Pharmacopoeia (TPI-336 EP), TPI-336 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TPI-336 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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