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Also known as: Podophyllotoxin, 518-28-5, Condylox, Condyline, (-)-podophyllotoxin, Wartec
Molecular Formula
C22H22O8
Molecular Weight
414.4  g/mol
InChI Key
YJGVMLPVUAXIQN-XVVDYKMHSA-N
FDA UNII
L36H50F353

Podophyllotoxin
A lignan (LIGNANS) found in PODOPHYLLIN resin from the roots of PODOPHYLLUM plants. It is a potent spindle poison, toxic if taken internally, and has been used as a cathartic. It is very irritating to skin and mucous membranes, has keratolytic actions, has been used to treat warts and keratoses, and may have antineoplastic properties, as do some of its congeners and derivatives.
The physiologic effect of podofilox is by means of Decreased Mitosis.
1 2D Structure

Podophyllotoxin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(5R,5aR,8aR,9R)-5-hydroxy-9-(3,4,5-trimethoxyphenyl)-5a,6,8a,9-tetrahydro-5H-[2]benzofuro[5,6-f][1,3]benzodioxol-8-one
2.1.2 InChI
InChI=1S/C22H22O8/c1-25-16-4-10(5-17(26-2)21(16)27-3)18-11-6-14-15(30-9-29-14)7-12(11)20(23)13-8-28-22(24)19(13)18/h4-7,13,18-20,23H,8-9H2,1-3H3/t13-,18+,19-,20-/m0/s1
2.1.3 InChI Key
YJGVMLPVUAXIQN-XVVDYKMHSA-N
2.1.4 Canonical SMILES
COC1=CC(=CC(=C1OC)OC)C2C3C(COC3=O)C(C4=CC5=C(C=C24)OCO5)O
2.1.5 Isomeric SMILES
COC1=CC(=CC(=C1OC)OC)[C@H]2[C@@H]3[C@H](COC3=O)[C@H](C4=CC5=C(C=C24)OCO5)O
2.2 Other Identifiers
2.2.1 UNII
L36H50F353
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Condyline

2. Condylox

3. Cph86

4. Epipodophyllotoxin

5. Podocon-25

6. Podofilm

7. Podophyllotoxin

8. Podophyllotoxin, (5r-(5 Alpha,5a Alpha,8a Alpha,9 Alpha))-isomer

9. Podophyllotoxin, (5r-(5 Alpha,5a Alpha,8a Alpha,9 Beta))-isomer

10. Podophyllotoxin, (5r-(5 Alpha,5a Alpha,8a Beta,9 Alpha))-isomer

11. Podophyllotoxin, (5r-(5 Alpha,5a Beta,8a Alpha,9 Beta))-isomer

12. Wartec

13. Warticon

2.3.2 Depositor-Supplied Synonyms

1. Podophyllotoxin

2. 518-28-5

3. Condylox

4. Condyline

5. (-)-podophyllotoxin

6. Wartec

7. Podophyllinic Acid Lactone

8. Podophyllotoxin 7

9. Warticon

10. Podofilox [usan]

11. Podophyllum

12. Nsc24818

13. Chembl61

14. Mfcd00075290

15. Nsc-24818

16. (10r,11r,15r,16r)-16-hydroxy-10-(3,4,5-trimethoxyphenyl)-4,6,13-trioxatetracyclo[7.7.0.0^{3,7}.0^{11,15}]hexadeca-1(9),2,7-trien-12-one

17. (5r,5ar,8ar,9r)-5-hydroxy-9-(3,4,5-trimethoxyphenyl)-5a,6,8a,9-tetrahydro-5h-[2]benzofuro[5,6-f][1,3]benzodioxol-8-one

18. Mls000069495

19. (5r,5ar,8ar,9r)-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-5,8,8a,9-tetrahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-6(5ah)-one

20. Chebi:50305

21. Podofilox (usan)

22. L36h50f353

23. (5r,5ar,8ar,9r)-5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)furo(3',4':6,7)naphtho(2,3-d)-1,3-dioxol-6(5ah)-one

24. Ncgc00022001-05

25. Podofilm

26. Smr000059121

27. Nsc 24818

28. Dsstox_cid_25645

29. Dsstox_rid_81023

30. Dsstox_gsid_45645

31. (5r,5ar,8ar,9r)-5-hydroxy-9-(3,4,5-trimethoxyphenyl)-5a,6,8a,9-tetrahydro-5h-isobenzofuro[5,6-f][1,3]benzodioxol-8-one

32. (5r,5ar,8ar,9r)-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-5,5a,8a,9-tetrahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-6(8h)-one

33. Podocon-25

34. Podophilox

35. (5r,5ar,8ar,9r)-5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5ah)-one

36. Ccris 565

37. Hsdb 7238

38. Sr-05000001749

39. Mls002702981

40. Einecs 208-250-4

41. Podofillina

42. Podophylotoxin

43. Ai3-50456

44. Mayapple Isolate

45. Unii-l36h50f353

46. Condylox (tn)

47. Cas-518-28-5

48. Podophyllotoxin,(s)

49. Prestwick_1018

50. Furo(3',4':6,7)naphtho(2,3-d)-1,3-dioxol-6(5ah)-one, 5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-, (5r-(5alpha,5abeta,8aalpha,9alpha))-

51. Podofillina [italian]

52. Podophyllotoxin (ban)

53. Podophyllotoxin, 95%

54. Spectrum_000199

55. Podofilox [hsdb]

56. Opera_id_1397

57. Prestwick0_000782

58. Prestwick1_000782

59. Prestwick2_000782

60. Prestwick3_000782

61. Spectrum2_000878

62. Spectrum4_000592

63. Spectrum5_001368

64. Podofilox [vandf]

65. Upcmld-dp035

66. Podophyllotoxin [mi]

67. Schembl42243

68. Bspbio_000884

69. Bspbio_002352

70. Kbiogr_001084

71. Kbioss_000679

72. Mls001148204

73. Mls002172467

74. Mls006010754

75. Mls006011412

76. Bidd:gt0123

77. Divk1c_000292

78. Unii-16902yvy2b

79. Spbio_000955

80. Spbio_002823

81. Bpbio1_000974

82. Ccris 4391

83. Podofilox [orange Book]

84. Podophyllotoxin [mart.]

85. Dtxsid3045645

86. Podophyllotoxin [who-dd]

87. Upcmld-dp035:001

88. Upcmld-dp035:002

89. Bcbcmap01_000165

90. Hms500o14

91. Kbio1_000292

92. Kbio2_000679

93. Kbio2_003247

94. Kbio2_005815

95. Amy2648

96. Ninds_000292

97. 16902yvy2b

98. Hms1570m06

99. Hms2093p16

100. Hms2097m06

101. Hms2235a23

102. Hms3259j19

103. Hms3714m06

104. Pharmakon1600-02300332

105. (5r,5ar,8ar,9r)-5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-furo(3',4':6,7)naphtho[2,3-d]-1,3-dioxol-6(5ah)-one

106. 9-hydroxy-5-(3,4,5-trimethoxyphenyl)-5,8,8a,9-tetrahydrofuro[3',4':6,7]naphtho[2,3-d][1,3]dioxol-6(5ah)-one

107. Albb-020906

108. Bcp24085

109. Furo(3',4':6,7)naphtho(2,3-d)-1,3-dioxol-6(5ah)-one, 5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-, (5r-(5.alpha.,5a.beta.,8a.alpha.,9.alpha.))-

110. Podophyllotoxin, Analytical Standard

111. Zinc3861806

112. Einecs 232-546-2

113. Tox21_110874

114. Tox21_202922

115. B18-5c

116. Bbl033695

117. Bdbm50035218

118. Ccg-39894

119. Nsc759591

120. Stk801918

121. Podophyllotoxin [ep Monograph]

122. Akos000265559

123. Tox21_110874_1

124. Ac-1656

125. Cs-1185

126. Db01179

127. Ks-1281

128. Nc00675

129. Nd-1185

130. Nsc-759591

131. Sdccgmls-0066888.p001

132. Idi1_000292

133. Smp1_000243

134. Ncgc00022001-03

135. Ncgc00022001-07

136. Ncgc00022001-08

137. Ncgc00022001-09

138. Ncgc00022001-10

139. Ncgc00022001-11

140. Ncgc00022001-13

141. Ncgc00022001-14

142. Ncgc00260468-01

143. (5r,9r,5ar,8ar)-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-5,8,9,5a,8a-pentahydro-2h -isobenzofurano[5',6'-2,1]benzo[4,5-d]1,3-dioxolan-6-one

144. 1,3,3a,4,9,9a-hexahydro-9-hydroxy-6,7-(methylenedioxy)-4-(3',4',5'-trimethoxyphenyl)benz(f)isobenzofuran-3-one

145. Hy-15552

146. Nci60_001981

147. Rd4-6269

148. P1771

149. En300-52746

150. D05529

151. P-6980

152. 518p285

153. A828801

154. Q421193

155. Sr-01000003030

156. Sr-01000003030-3

157. Sr-05000001749-1

158. Sr-05000001749-2

159. Brd-k47869605-001-05-6

160. Brd-k47869605-001-18-9

161. Z1258578359

162. (10r,11r,15r,16r)-16-hydroxy-10-(3,4,5-trimethoxyphenyl)-4,6,13-trioxatetracyclo[7.7.0.0?,?.0??,??]hexadeca-1(9),2,7-trien-12-one

163. (10r,11r,15r,16r)-16-hydroxy-10-(3,4,5-trimethoxyphenyl)-4,6,13-trioxatetracyclo[7.7.0.03,7.011,15]hexadeca-1,3(7),8-trien-12-one

164. (5r,5ar,8ar,9r)-5-hydroxy-9-(3,4,5-trimethoxyphenyl)-5a,6,8a,9-tetrahydro-5h-isobenzofuro[6,5-f][1,3]benzodioxol-8-one

165. (5r,5ar,8ar,9r)-5-oxidanyl-9-(3,4,5-trimethoxyphenyl)-5a,6,8a,9-tetrahydro-5h-[2]benzofuro[5,6-f][1,3]benzodioxol-8-one

166. 11016-28-7

167. 5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5ah)-one, [5r-(5.alpha.,5a.beta.,8a.alpha.,9.alpha.)]

168. Furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5ah)-one, 5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-, (5r,5ar,8ar,9r)-

169. Furo[3',7]naphtho[2,3-d]-1,3-dioxol-6(5ah)-one, 5,8,8a,9-tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)-, [5r-(5.alpha.,5a.beta.,8a.alpha.,9.alpha.)]-

170. Naphtho[2,3-dioxole-6-carboxylic Acid, 5,6,7,8-tetrahydro-8-hydroxy-7-(hydroxymethyl)-5-(3,4,5-trimethoxyphenyl-, .gamma.-lactone

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 414.4 g/mol
Molecular Formula C22H22O8
XLogP32
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count8
Rotatable Bond Count4
Exact Mass414.13146766 g/mol
Monoisotopic Mass414.13146766 g/mol
Topological Polar Surface Area92.7 Ų
Heavy Atom Count30
Formal Charge0
Complexity629
Isotope Atom Count0
Defined Atom Stereocenter Count4
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 NameCondylox
PubMed HealthPodofilox (On the skin)
Drug ClassesKeratolytic
Drug LabelCondylox is the brand name of podofilox, an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Condylox 0.5% Solution is formulated for top...
Active IngredientPodofilox
Dosage FormGel; Solution
RouteTopical
Strength0.5%
Market StatusPrescription
CompanyWatson Pharms

2 of 4  
Drug NamePodofilox
Drug LabelPodofilox Topical Solution 0.5% is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Podofilox Topical Solution 0.5% is formulated for...
Active IngredientPodofilox
Dosage FormSolution
RouteTopical
Strength0.5%
Market StatusPrescription
CompanyPrecision Dermat; Paddock

3 of 4  
Drug NameCondylox
PubMed HealthPodofilox (On the skin)
Drug ClassesKeratolytic
Drug LabelCondylox is the brand name of podofilox, an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Condylox 0.5% Solution is formulated for top...
Active IngredientPodofilox
Dosage FormGel; Solution
RouteTopical
Strength0.5%
Market StatusPrescription
CompanyWatson Pharms

4 of 4  
Drug NamePodofilox
Drug LabelPodofilox Topical Solution 0.5% is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Podofilox Topical Solution 0.5% is formulated for...
Active IngredientPodofilox
Dosage FormSolution
RouteTopical
Strength0.5%
Market StatusPrescription
CompanyPrecision Dermat; Paddock

4.2 Therapeutic Uses

Antiviral (topical)

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1355


Podofilox is indicated for the treatment of condyloma acuminatum of the external genital areas; the gel, but not the solution, may be used for perianal warts. Neither the gel nor the solution should be used to treat warts on mucous membranes, including membranous areas of the urethra, rectum, and vagina. /Included in US product labeling/

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2337


4.3 Drug Warning

Because of the potential for adverse local reactions, the recommended dose, frequency of application, and duration of treatment of topical podofilox should not be exceeded. There is no evidence that applying podofilox more frequently than recommended would increase efficacy; however, more frequent application would be expected to increase the risk of local adverse reactions and increase systemic absorption of the drug.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3455


Pregnancy risk category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2337


Podofilox generally is well tolerated when applied topically. In clinical studies evaluating topical podofilox in otherwise healthy adults 18 years of age or older with external genital and/or perianal warts caused by human papillomavirus, up to 6% of patients discontinued the drug because of adverse local reactions; however, serious systemic effects have not been reported to date.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3455


Adverse local reactions, including burning, pain, inflammation, erosion, and pruritus, commonly occur at the site of application of podofilox 0.5% gel or 0.5% solution. These reactions usually are mild to moderate in severity; however, severe local reactions have been reported, especially during the first 2 weeks of therapy. Adverse local reactions generally resolve within 4 weeks following completion of topical podofilox therapy.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3455


For more Drug Warnings (Complete) data for PODOFILOX (9 total), please visit the HSDB record page.


4.4 Drug Indication

For treatment of external genital warts (Condyloma acuminatum).


5 Pharmacology and Biochemistry
5.1 Pharmacology

Podofilox, also called podophyllotoxin, is a purer and more stable form of podophyllin in which only the biologically active portion of the compound is present. Podofilox is used to remove certain types of warts on the outside skin of the genital areas.


5.2 MeSH Pharmacological Classification

Antineoplastic Agents, Phytogenic

Agents obtained from higher plants that have demonstrable cytostatic or antineoplastic activity. (See all compounds classified as Antineoplastic Agents, Phytogenic.)


Keratolytic Agents

Agents that soften, separate, and cause desquamation of the cornified epithelium or horny layer of skin. They are used to expose mycelia of infecting fungi or to treat corns, warts, and certain other skin diseases. (See all compounds classified as Keratolytic Agents.)


Tubulin Modulators

Agents that interact with TUBULIN to inhibit or promote polymerization of MICROTUBULES. (See all compounds classified as Tubulin Modulators.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
PODOFILOX
5.3.2 FDA UNII
L36H50F353
5.3.3 Pharmacological Classes
Decreased Mitosis [PE]
5.4 ATC Code

D - Dermatologicals

D06 - Antibiotics and chemotherapeutics for dermatological use

D06B - Chemotherapeutics for topical use

D06BB - Antivirals

D06BB04 - Podophyllotoxin


5.5 Absorption, Distribution and Excretion

Absorption

Topical application of 0.05 mL of 0.5% podofilox solution to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application.


Small amounts of podofilox may be absorbed systemically following topical application. In a study in adults with anogenital warts caused by human papillomavirus, topical application of 0.05 mL of podofilox 0.5% solution to external genitalia did not result in detectable serum concentrations of the drug; however, topical application of 0.1-1.5mL of the solution resulted in peak serum concentrations of 1-17 ng/mL at 1-2 hours after application.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3456


5.6 Biological Half-Life

1.0 to 4.5 hours.


The serum elimination half-life of podofilox is estimated to range from 1-4.5 hours.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2004. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2004 (Plus Supplements)., p. 3456


5.7 Mechanism of Action

The exact mechanism of action is not well understood. It does appear, however, that it and its derivatives may bind and inhibit topoisomerase II during the late S and early G2 stage. The drug may bind and stabilize the temporary break caused by the enzyme. This disrupts the reparation of the break through which the double-stranded DNA passes, and consequently stops DNA unwinding and replication


The exact mechanism of action for podofilox is unknown. Podofilox is a potent mitotoxic agent that inhibits cell mitosis; cell division stops, other cellular processes are impaired, necrosis occurs, and the affected tissues gradually erode.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 2337


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[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1648578600,"product":"PODOPHYLLOTOXIN BATCH NO.: 22PP002\/122","address":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM","city":"NAVI MUMBAI","supplier":"ZYDUS TAKEDA HEALTHCARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BERLIN","customer":"TAKEDA GMBHFIRMA","customerCountry":"GERMANY","quantity":"2.63","actualQuantity":"2.625","unit":"KGS","unitRateFc":"14333","totalValueFC":"40672","currency":"EURO","unitRateINR":1180952.3809523811,"date":"30-Mar-2022","totalValueINR":"3100000","totalValueInUsd":"40672","indian_port":"BOMBAY AIR","hs_no":"29145000","bill_no":"9346493","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659033000,"product":"PODOPHYLLOTOXIN","address":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM","city":"NAVI MUMBAI","supplier":"ZYDUS TAKEDA HEALTHCARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"FIRMA TAKEDA GMBH FIRMA","customerCountry":"GERMANY","quantity":"2.77","actualQuantity":"2.765","unit":"KGS","unitRateFc":"15049.7","totalValueFC":"41991.3","currency":"EURO","unitRateINR":1207594.9367088608,"date":"29-Jul-2022","totalValueINR":"3339000","totalValueInUsd":"41991.3","indian_port":"JNPT","hs_no":"29145000","bill_no":"3167936","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668623400,"product":"PODOPHYLLOTOXIN","address":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM","city":"NAVI MUMBAI","supplier":"ZYDUS TAKEDA HEALTHCARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"UNDISCLOSED","customerCountry":"GERMANY","quantity":"1.85","actualQuantity":"1.845","unit":"KGS","unitRateFc":"15049.7","totalValueFC":"27238.4","currency":"EURO","unitRateINR":1204878.0487804879,"date":"17-Nov-2022","totalValueINR":"2223000","totalValueInUsd":"27238.4","indian_port":"JNPT","hs_no":"29145000","bill_no":"5525617","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674498600,"product":"PODOPHYLLOTOXIN","address":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM","city":"NAVI MUMBAI","supplier":"ZYDUS TAKEDA HEALTHCARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"UNDISCLOSED","customerCountry":"GERMANY","quantity":"2.72","actualQuantity":"2.715","unit":"KGS","unitRateFc":"15049.7","totalValueFC":"43151","currency":"EURO","unitRateINR":1299447.5138121548,"date":"24-Jan-2023","totalValueINR":"3528000","totalValueInUsd":"43151","indian_port":"JNPT","hs_no":"29145000","bill_no":"7238515","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680546600,"product":"PODOPHYLLOTOXIN","address":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM","city":"NAVI MUMBAI","supplier":"ZYDUS TAKEDA HEALTHCARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"UNDISCLOSED","customerCountry":"GERMANY","quantity":"1.39","actualQuantity":"1.385","unit":"KGS","unitRateFc":"15049.7","totalValueFC":"21927","currency":"EURO","unitRateINR":1297472.9241877256,"date":"04-Apr-2023","totalValueINR":"1797000","totalValueInUsd":"21927","indian_port":"JNPT","hs_no":"29145000","bill_no":"9065047","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"C\/4, MIDC, VILLAGE PAWANE THANE BELAPUR ROAD, VASHI NAVI MUM, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703097000,"product":"PODOPHYLLOTOXIN","address":"C\/4, MIDC, TTC INDUSTRIAL AREA,","city":"VASHI, NAVI MUMBAI","supplier":"ZYDUS TAKEDA HEALTHCARE PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"HAMBURG","customer":"TAKEDA GMBH FIRMA","customerCountry":"GERMANY","quantity":"2.16","actualQuantity":"2.161","unit":"KGS","unitRateFc":"15049.7","totalValueFC":"34477.3","currency":"EURO","unitRateINR":1328088.8477556687,"date":"21-Dec-2023","totalValueINR":"2870000","totalValueInUsd":"34477.3","indian_port":"JNPT","hs_no":"29145000","bill_no":"6207280","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"C\/4, MIDC, TTC INDUSTRIAL AREA,, VASHI, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657650600,"product":"4-DEMETHYL-EPI-PODOPHYLLOTOXIN","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"SHANGHAI JINHE BIO PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"50.10","actualQuantity":"50.1","unit":"KGS","unitRateFc":"2700","totalValueFC":"135922.3","currency":"USD","unitRateINR":"215730","date":"13-Jul-2022","totalValueINR":"10808073","totalValueInUsd":"135922.3","indian_port":"BOMBAY AIR","hs_no":"29329990","bill_no":"9533703","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676831400,"product":"4\\'-DEMETHYL-EPI-PODOPHYLLOTOXIN","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"SHANGHAI JINHE BIO PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"50.05","actualQuantity":"50.05","unit":"KGS","unitRateFc":"2150","totalValueFC":"108988.6","currency":"USD","unitRateINR":"179847.5","date":"20-Feb-2023","totalValueINR":"9001367.38","totalValueInUsd":"108988.6","indian_port":"BOMBAY AIR","hs_no":"29329990","bill_no":"4716649","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691433000,"product":"4-DEMETHYL-EPI-PODOPHYLLOTOXINCAS#:6559-91-7","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL","city":"MUMBAI","supplier":"SHANGHAI JINHE BIO PHARMACEUTICALS CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"2100","totalValueFC":"105946.8","currency":"USD","unitRateINR":"173769.6","date":"08-Aug-2023","totalValueINR":"8776244.4","totalValueInUsd":"105946.8","indian_port":"SAHAR AIR","hs_no":"29329990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698777000,"product":"4-DEMETHYL-EPI-PODOPHYLLOTOXIN(CAS#:6559-91-7)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SHANGHAI JINHE BIO PHARMACEUTICALS CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"2100","totalValueFC":"212343.1","currency":"USD","unitRateINR":"176820","date":"01-Nov-2023","totalValueINR":"17682000","totalValueInUsd":"212343.1","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"8570116","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO. 508 MAODIAN ROAD, LIANTANG, QINGPU DISTRICT, SHANGHAI,201716, CHINA China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707157800,"product":"4-DEMETHYL-EPI-PODOPHYLLOTOXIN(CAS#:6559-91-7)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SHANGHAI JINHE BIO PHARMACEUTICALS CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"119.00","actualQuantity":"119","unit":"KGS","unitRateFc":"2400","totalValueFC":"288960.2","currency":"USD","unitRateINR":"201480","date":"06-Feb-2024","totalValueINR":"23976120","totalValueInUsd":"288960.2","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"2000697","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO. 508 MAODIAN ROAD, LIANTANG, QINGPU DISTRICT, SHANGHAI,201716, CHINA China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"4\\'-DEMETHYLEPIPODOPHYLLOTOXIN - CS-1426 - 6559-91-7 29322090","address":"102\/12 KRISHNA GREENLAND PARK,KASA","city":"THANE,MAHARASHTRA","supplier":"SHANGHAI KAIXIN PHARMACEUTICALS CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"JINAY PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"1.8","totalValueFC":"367.5","currency":"USD","unitRateINR":"157.3","date":"15-Apr-2025","totalValueINR":"31461.78","totalValueInUsd":"367.5","indian_port":"Bombay Air","hs_no":"29322090","bill_no":"9496994","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":",LTD ROOM 502,5\/F NO.2 BUILDING 720 CAIL ZHANGJIANG HIGH-TECH PARK SHANGHAI CHINA","customerAddress":"102\/12 KRISHNA GREENLAND PARK,KASA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745519400,"product":"4-DEMETHYL-EPI-PODOPHYLLOTOXIN (CAS#:6559-91-7) 4-DEMETHYL-EPI-PODOPHYLLOTOXIN(CAS#:6559-91-7)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SHANGHAI JINHE BIO PHARMACEUTICALS CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"2600","totalValueFC":"131212.2","currency":"USD","unitRateINR":"224640","date":"25-Apr-2025","totalValueINR":"11232000","totalValueInUsd":"131212.2","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"9703374","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO. 508 MAODIAN ROAD, LIANTANG, QIN GPU DISTRICT, SHANGHAI,201716, CHIN A China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1758479400,"product":"100KG 4\\'-DEMETHYL-EPI-PODOPHYLLOTOXIN (25KG\/BAG\/DRUM,4DRUMS)(CAS#:6559-91-7)150KG 4\\'-DEMETHYL-EPI-PODOPHYLLOTOXIN (25KG\/BAG\/DRUM,6DRUMS)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SHANGHAI JINHE BIO PHARMACEUTICALS CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"2950","totalValueFC":"296941.6","currency":"USD","unitRateINR":"262107.5","date":"22-Sep-2025","totalValueINR":"26210750","totalValueInUsd":"296941.6","indian_port":"Bombay Air","hs_no":"29329990","bill_no":"4656110","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO. 508 MAODIAN ROAD, LIANTANG, QIN GPU DISTRICT, SHANGHAI,201716, CHIN A China","customerAddress":"MUMBAI CENTRAL,"}]
30-Mar-2022
22-Sep-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDF Dossiers

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01

PODOFILOX

Brand Name : CONDYLOX

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.5%

Packaging :

Approval Date : 1997-03-13

Application Number : 20529

Regulatory Info : RX

Registration Country : USA

Abbvie CB

02

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Condyline

Dosage Form :

Dosage Strength : Skin Soluz 3.5 Ml 0.5%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

BIO Partnering at JPM
Not Confirmed
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arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : PODOFILOX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Packaging :

Approval Date : 2010-07-21

Application Number : 90184

Regulatory Info : DISCN

Registration Country : USA

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04

Galderma

Switzerland
BIO Partnering at JPM
Not Confirmed
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Galderma

Switzerland
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Condyline

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Condylin

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Condyline

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

07

Padagis

Israel
BIO Partnering at JPM
Not Confirmed
arrow

Padagis

Israel
arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : PODOFILOX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Packaging :

Approval Date : 2002-01-29

Application Number : 75600

Regulatory Info : RX

Registration Country : USA

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08

Padagis

Israel
BIO Partnering at JPM
Not Confirmed
arrow

Padagis

Israel
arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : PODOFILOX

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.5%

Packaging :

Approval Date : 2023-11-22

Application Number : 211871

Regulatory Info : RX

Registration Country : USA

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09

Stiefel

United Kingdom
BIO Partnering at JPM
Not Confirmed
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Stiefel

United Kingdom
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Wartec

Dosage Form :

Dosage Strength : Cream U.E. 5 G 0.15%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

BIO Partnering at JPM
Not Confirmed
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arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : CONDYLOX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Packaging :

Approval Date : 1990-12-13

Application Number : 19795

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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01

ALLERGAN

U.S.A

PODOFILOX

Brand Name : CONDYLOX

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.5%

Approval Date : 1997-03-13

Application Number : 20529

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Abbvie CB

02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : PODOFILOX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Approval Date : 2010-07-21

Application Number : 90184

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

PADAGIS US

Israel
BIO Partnering at JPM
Not Confirmed
arrow

PADAGIS US

Israel
arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : PODOFILOX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Approval Date : 2002-01-29

Application Number : 75600

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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04

PADAGIS US

Israel
BIO Partnering at JPM
Not Confirmed
arrow

PADAGIS US

Israel
arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : PODOFILOX

Dosage Form : GEL;TOPICAL

Dosage Strength : 0.5%

Approval Date : 2023-11-22

Application Number : 211871

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

05

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

PODOFILOX

Brand Name : CONDYLOX

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Approval Date : 1990-12-13

Application Number : 19795

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AT

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Europe

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01

2Care4 Aps

Denmark
BIO Partnering at JPM
Not Confirmed
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2Care4 Aps

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Podofyllotoxin

Brand Name : Condyline

Dosage Form : Cutaneous Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 03/12/2014

Application Number : 20140304000062

Regulatory Info : Deregistered

Registration Country : Sweden

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02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Condyline

Dosage Form :

Dosage Strength : Skin Soluz 3.5 Ml 0.5%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

03

Galderma Nordic Ab

Switzerland
BIO Partnering at JPM
Not Confirmed
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Galderma Nordic Ab

Switzerland
arrow
BIO Partnering at JPM
Not Confirmed

Podofyllotoxin

Brand Name : Condyline

Dosage Form : Cutaneous Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 12/06/1987

Application Number : 19870612000068

Regulatory Info : Deregistered

Registration Country : Sweden

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04

Orifarm AS

Denmark
BIO Partnering at JPM
Not Confirmed
arrow

Orifarm AS

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Condylin

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

05

Orifarm AS

Denmark
BIO Partnering at JPM
Not Confirmed
arrow

Orifarm AS

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Condyline

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

06

Orifarm Ab

Denmark
BIO Partnering at JPM
Not Confirmed
arrow

Orifarm Ab

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Podofyllotoxin

Brand Name : Condylin

Dosage Form : Cutaneous Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 07/05/2014

Application Number : 20131023000051

Regulatory Info : Deregistered

Registration Country : Sweden

blank

07

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Podofyllotoxin

Brand Name : Wartec

Dosage Form : Cream

Dosage Strength : 0.0015

Packaging :

Approval Date : 12/03/1999

Application Number : 19990312000059

Regulatory Info : Approved

Registration Country : Sweden

blank

08

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Podofyllotoxin

Brand Name : Wartec

Dosage Form : Cutaneous Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 08/11/1985

Application Number : 19851108000052

Regulatory Info : Approved

Registration Country : Sweden

blank

09

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Wartec

Dosage Form : Cutaneous Solution

Dosage Strength : 5MG

Packaging :

Approval Date : 1991-06-01

Application Number : 58844

Regulatory Info : Authorized

Registration Country : Spain

blank

10

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Brand Name : Wartec

Dosage Form : Cream

Dosage Strength : 0.15%

Packaging : Tube

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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DRUG PRODUCT COMPOSITIONS

Do you need Business Intel? Ask us

DOSAGE - SOLUTION;TOPICAL - 0.5%

USFDA APPLICATION NUMBER - 19795

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DOSAGE - GEL;TOPICAL - 0.5%

USFDA APPLICATION NUMBER - 20529

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EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

Grade : Topical, Parenteral

Category : Parenteral, Topical

03

Actylis

U.S.A
BIO Partnering at JPM
Not Confirmed
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Actylis

U.S.A
BIO Partnering at JPM
Not Confirmed
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Topical

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DATA COMPILATION #PharmaFlow

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FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments
This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  

Impressions: 5197

https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

#PharmaFlow by PHARMACOMPASS
11 Jul 2024

NEWS #PharmaBuzz

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US Medicaid Prescriptions

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Biotech Showcase
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Company : Allergan Inc.

Podofilox

Drug Cost (USD) : 16,598

Year : 2023

Prescribers : 25

Prescriptions : 25

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Company : Actavis/Teva

Podofilox

Drug Cost (USD) : 74,566

Year : 2023

Prescribers : 971

Prescriptions : 1417

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Company : Padagis

Podofilox

Drug Cost (USD) : 273,944

Year : 2023

Prescribers : 3066

Prescriptions : 4389

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Company : Actavis/Teva

Podofilox

Drug Cost (USD) : 69,936

Year : 2022

Prescribers : 905

Prescriptions : 1307

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Company : Allergan Inc.

Podofilox

Drug Cost (USD) : 308,390

Year : 2022

Prescribers : 348

Prescriptions : 440

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06

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Company : Perrigo/Padagis

Podofilox

Drug Cost (USD) : 247,960

Year : 2022

Prescribers : 2840

Prescriptions : 3925

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07

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Company : Actavis/Teva

Podofilox

Drug Cost (USD) : 117,857

Year : 2021

Prescribers : 1364

Prescriptions : 2007

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08

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Company : Allergan Inc.

Podofilox

Drug Cost (USD) : 421,866

Year : 2021

Prescribers : 406

Prescriptions : 561

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09

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Company : Perrigo/Padagis

Podofilox

Drug Cost (USD) : 214,956

Year : 2021

Prescribers : 2436

Prescriptions : 3404

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Biotech Showcase
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Company : Actavis/Teva

Podofilox

Drug Cost (USD) : 162,308

Year : 2020

Prescribers : 1663

Prescriptions : 2731

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Regulatory FDF Prices

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Brand Name : Condyline

Japan
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BIO Partnering at JPM
Not Confirmed

Brand Name : Condyline

Japan
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form :

Dosage Strength : Skin Soluz 3.5 Ml 0.5%  

Price Per Pack (Euro) : 20.91

Published in :

Country : Italy

RX/OTC/DISCN : Class C

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03

Brand Name : Wartec

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Brand Name : Wartec

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form :

Dosage Strength : Cream U.E. 5 G 0.15%  

Price Per Pack (Euro) : 27.54

Published in :

Country : Italy

RX/OTC/DISCN : Class C

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04

Brand Name : Wartec

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Brand Name : Wartec

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form : Cream

Dosage Strength : 0.15%

Price Per Pack (Euro) : 21.604

Published in :

Country : Norway

RX/OTC/DISCN :

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05

Brand Name : Condyline

Switzerland
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BIO Partnering at JPM
Not Confirmed

Brand Name : Condyline

Switzerland
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Price Per Pack (Euro) : 18.931

Published in :

Country : Norway

RX/OTC/DISCN :

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06

Brand Name : Condylin

Denmark
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BIO Partnering at JPM
Not Confirmed

Brand Name : Condylin

Denmark
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Price Per Pack (Euro) : 18.931

Published in :

Country : Norway

RX/OTC/DISCN :

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07

Brand Name : Condyline

Denmark
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BIO Partnering at JPM
Not Confirmed

Brand Name : Condyline

Denmark
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Price Per Pack (Euro) : 18.931

Published in :

Country : Norway

RX/OTC/DISCN :

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08

Brand Name : Wartec

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Brand Name : Wartec

United Kingdom
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form : Liniment, resolution

Dosage Strength : 5 mg/ml

Price Per Pack (Euro) : 18.183

Published in :

Country : Norway

RX/OTC/DISCN :

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09

Brand Name : PODOFILOX

Israel
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BIO Partnering at JPM
Not Confirmed

Brand Name : PODOFILOX

Israel
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : RX

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10

Brand Name : CONDYLOX

Israel
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BIO Partnering at JPM
Not Confirmed

Brand Name : CONDYLOX

Israel
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BIO Partnering at JPM
Not Confirmed

Podophyllotoxin

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 0.5%

Price Per Pack :

Published in :

Country : USA

RX/OTC/DISCN : RX

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ABOUT THIS PAGE

Looking for 477-47-4 / Podophyllotoxin API manufacturers, exporters & distributors?

Podophyllotoxin manufacturers, exporters & distributors 1

66

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

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

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

API | Excipient name

Podophyllotoxin

Synonyms

518-28-5, Condylox, Condyline, (-)-podophyllotoxin, Wartec, Podophyllinic acid lactone

Cas Number

477-47-4

Unique Ingredient Identifier (UNII)

L36H50F353

About Podophyllotoxin

A lignan (LIGNANS) found in PODOPHYLLIN resin from the roots of PODOPHYLLUM plants. It is a potent spindle poison, toxic if taken internally, and has been used as a cathartic. It is very irritating to skin and mucous membranes, has keratolytic actions, has been used to treat warts and keratoses, and may have antineoplastic properties, as do some of its congeners and derivatives.

Condyline Manufacturers

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

Condyline Suppliers

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

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

Condyline USDMF

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

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

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

Condyline WC

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

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

Condyline 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 Condyline as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Condyline GMP

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

Condyline CoA

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

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

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