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Chemistry

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Also known as: 83-44-3, Deoxycholate, Desoxycholic acid, Cholerebic, Cholorebic, Choleic acid
Molecular Formula
C24H40O4
Molecular Weight
392.6  g/mol
InChI Key
KXGVEGMKQFWNSR-LLQZFEROSA-N
FDA UNII
005990WHZZ

Deoxycholic Acid
A bile acid formed by bacterial action from cholate. It is usually conjugated with glycine or taurine. Deoxycholic acid acts as a detergent to solubilize fats for intestinal absorption, is reabsorbed itself, and is used as a choleretic and detergent.
Deoxycholic acid is a Cytolytic Agent. The physiologic effect of deoxycholic acid is by means of Decreased Cell Membrane Integrity.
1 2D Structure

Deoxycholic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R)-4-[(3R,5R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
2.1.2 InChI
InChI=1S/C24H40O4/c1-14(4-9-22(27)28)18-7-8-19-17-6-5-15-12-16(25)10-11-23(15,2)20(17)13-21(26)24(18,19)3/h14-21,25-26H,4-13H2,1-3H3,(H,27,28)/t14-,15-,16-,17+,18-,19+,20+,21+,23+,24-/m1/s1
2.1.3 InChI Key
KXGVEGMKQFWNSR-LLQZFEROSA-N
2.1.4 Canonical SMILES
CC(CCC(=O)O)C1CCC2C1(C(CC3C2CCC4C3(CCC(C4)O)C)O)C
2.1.5 Isomeric SMILES
C[C@H](CCC(=O)O)[C@H]1CC[C@@H]2[C@@]1([C@H](C[C@H]3[C@H]2CC[C@H]4[C@@]3(CC[C@H](C4)O)C)O)C
2.2 Other Identifiers
2.2.1 UNII
005990WHZZ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 12beta-isomer Deoxycholic Acid

2. 3beta-isomer Deoxycholic Acid

3. 5alpha-isomer Deoxycholic Acid

4. Choleic Acid

5. Deoxycholate

6. Deoxycholate, Sodium

7. Deoxycholic Acid, 12beta Isomer

8. Deoxycholic Acid, 12beta-isomer

9. Deoxycholic Acid, 3beta Isomer

10. Deoxycholic Acid, 3beta-isomer

11. Deoxycholic Acid, 5alpha Isomer

12. Deoxycholic Acid, 5alpha-isomer

13. Deoxycholic Acid, Disodium Salt

14. Deoxycholic Acid, Magnesium (2:1) Salt

15. Deoxycholic Acid, Monoammonium Salt

16. Deoxycholic Acid, Monopotassium Salt

17. Deoxycholic Acid, Monosodium Salt

18. Deoxycholic Acid, Sodium Salt, 12beta-isomer

19. Desoxycholic Acid

20. Dihydroxycholanoic Acid

21. Kybella

22. Lagodeoxycholic Acid

23. Sodium Deoxycholate

2.3.2 Depositor-Supplied Synonyms

1. 83-44-3

2. Deoxycholate

3. Desoxycholic Acid

4. Cholerebic

5. Cholorebic

6. Choleic Acid

7. Degalol

8. Deoxycholatic Acid

9. Droxolan

10. Pyrochol

11. Septochol

12. Desoxycholsaeure

13. 7alpha-deoxycholic Acid

14. 3alpha,12alpha-dihydroxy-5beta-cholanic Acid

15. Cholic Acid, Deoxy-

16. Dihydroxycholanoic Acid

17. Atx-101

18. 7-deoxycholic Acid

19. Kybella

20. (3alpha,5beta,12alpha)-3,12-dihydroxycholan-24-oic Acid

21. 3,12-dihydroxycholanic Acid

22. Deoxy Cholic Acid

23. 3alpha,12alpha-dihydroxy-5beta-cholan-24-oic Acid

24. 5-beta-deoxycholic Acid

25. Desoxycholic Acid [nf]

26. Desoxycholsaeure [german]

27. Nsc8797

28. Nsc 8797

29. Nsc-8797

30. Mfcd00003673

31. (4r)-4-[(3r,5r,8r,9s,10s,12s,13r,14s,17r)-3,12-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]pentanoic Acid

32. (r)-4-((3r,5r,8r,9s,10s,12s,13r,14s,17r)-3,12-dihydroxy-10,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)pentanoic Acid

33. 7.alpha.-deoxycholic Acid

34. 3.alpha.,12.alpha.-dihydroxycholanic Acid

35. Dwj211

36. Chebi:28834

37. Cholan-24-oic Acid, 3,12-dihydroxy-, (3alpha,5beta,12alpha)-

38. Dwj-211

39. 005990whzz

40. 3-alpha,12-alpha-dihydroxycholansaeure [german]

41. 3-alpha,12-alpha-dihydroxy-5-beta-cholanoic Acid

42. Atx-101 (deoxycholic Acid)

43. 5beta-cholan-24-oic Acid, 3alpha,12alpha-dihydroxy-

44. 3-alpha,12-alpha-dihydroxy-5-beta-cholan-24-oic Acid

45. Cholan-24-oic Acid, 3,12-dihydroxy-, (3a,5b,12a)-

46. Cholan-24-oic, 3,12-dihydroxy-(3alpha,5beta,12alpha)-

47. 3,12-dihydroxycholan-24-oic Acid, (3alpha,5beta,12alpha)-

48. 17-beta-(1-methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol

49. L7-beta-(1-methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol

50. 3.alpha.,12.alpha.-dihydroxy-5.beta.-cholanic Acid

51. 3.alpha.,12.alpha.-dihydroxy-5.beta.-cholanoic Acid

52. 3.alpha.,12.alpha.-dihydroxy-5.beta.-cholan-24-oic Acid

53. 5-beta-cholan-24-oic Acid, 3-alpha,12-alpha-dihydroxy-

54. Cholan-24-oic Acid, 3,12-dihydroxy-, (3-alpha,5-beta,12-alpha)-

55. 17.beta.-(1-methyl-3-carboxypropyl)-etiocholane-3.alpha.,12.alpha.-diol

56. Atx 101

57. Dxc

58. Smr000112166

59. Deoxycholatate

60. De-oxycholate

61. 3-hydroxy-polydeoxycholic Acid

62. Deoxy-cholate

63. Unii-005990whzz

64. 3alpha-hydroxy-polydeoxycholate

65. Deoxycholic Acid [usan:inn]

66. Deoxycholic-acid

67. Atx101

68. Ccris 1627

69. Hsdb 293

70. 5b-deoxycholate

71. 3alpha

72. 7-deoxycholate

73. Deoxy-cholic Acid

74. Einecs 201-478-5

75. Kybella (tn)

76. 5b-deoxycholic Acid

77. 7-desoxycholic Acid

78. 3-alpha,12-alpha-dihydroxycholansaeure

79. Brn 3219882

80. 1e3v

81. Deoxycholic Acid [inn]

82. Spectrum5_002007

83. Bmse000833

84. Schembl4300

85. Deoxycholic Acid (nf/inn)

86. Bidd:pxr0198

87. Gtpl610

88. 4-10-00-01608 (beilstein Handbook Reference)

89. Mls001066423

90. Mls001306460

91. Deoxycholic Acid [ii]

92. Deoxycholic Acid [mi]

93. Chembl406393

94. Deoxycholic Acid [hsdb]

95. Deoxycholic Acid [inci]

96. Deoxycholic Acid [usan]

97. Desoxycholic Acid [fcc]

98. 5b-cholanic Acid-3a,12a-diol

99. Dtxsid0042662

100. Desoxycholic Acid [vandf]

101. Deoxycholic Acid [usp-rs]

102. Deoxycholic Acid [who-dd]

103. Hms2270h22

104. Hy-n0593

105. Zinc3914810

106. Deoxycholic Acid, >=98% (hplc)

107. Bbl013877

108. Bdbm50375599

109. Deoxycholic Acid, >=99.0% (t)

110. Lmst04010040

111. S4689

112. Stk801948

113. Akos005622617

114. Deoxycholic Acid [ep Impurity]

115. Deoxycholic Acid [orange Book]

116. Ccg-268565

117. Cs-7613

118. Db03619

119. Deoxycholic Acid [usp Monograph]

120. As-13233

121. Bp-13275

122. Nci60_041946

123. 3-.alpha.,12-.alpha.-dihydroxycholansaeure

124. Deoxycholic Acid, Bioxtra, >=98% (hplc)

125. C04483

126. D10781

127. D85117

128. Q425680

129. Sr-01000765601

130. 5.beta.-cholan-24-oic Acid,12.alpha.-dihydroxy-

131. Sr-01000765601-2

132. 3i+/-,12i+/--dihydroxy-5i(2)-cholansa Currencyure

133. Ursodeoxycholic Acid Impurity E [ep Impurity]

134. Z1945707492

135. 5.beta.-cholan-24-oic Acid, 3.alpha.,12.alpha.-dihydroxy-

136. 3,12-dihydroxycholan-24-oic Acid, (3.alpha.,5.beta.,12.alpha.)- #

137. Cholan-24-oic Acid,12-dihydroxy-, (3.alpha.,5.beta.,12.alpha.)-

138. Deoxycholic Acid, 500 Mug/ml In Methanol, Certified Reference Material

139. (3alpha,5alpha,8alpha,12alpha,14beta,17alpha)-3,12-dihydroxycholan-24-oic Acid

140. Cholan-24-oic Acid, 3,12-dihydroxy-, (3-.alpha., 5-.beta.,12-.alpha.)-

141. Cholan-24-oic Acid, 3,12-dihydroxy-, (3alpha,5beta,12alpha)-, Homopolymer

142. Deoxycholic Acid (desoxycholic Acid), United States Pharmacopeia (usp) Reference Standard

143. L7-.beta.-(1-methyl-3-carboxypropyl)-etiocholane-3-.alpha.,12-.alpha.-diol

144. (4r)-4-((3r,8r,9s,10s,12s,13r,14s,17r)-3,12-dihydroxy-10,13-dimethylhexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)pentanoic Acid

145. (4r)-4-[(1s,2s,5r,7r,10r,11s,14r,15r,16s)-5,16-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic Acid

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 392.6 g/mol
Molecular Formula C24H40O4
XLogP34.9
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count4
Exact Mass392.29265975 g/mol
Monoisotopic Mass392.29265975 g/mol
Topological Polar Surface Area77.8 Ų
Heavy Atom Count28
Formal Charge0
Complexity605
Isotope Atom Count0
Defined Atom Stereocenter Count10
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Cholagogues and Choleretics; Detergents

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


The useful effects of exogenous bile acids result from their capacity to decrease the cholesterol content of the bile and promote dissolution of cholesterol gallstones. /Bile acids/

Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 935


VET USE: TO INCR VOL OF BILE WITHOUT SIGNIFICANTLY ALTERING PROPORTIONS OF ITS CONSTITUENTS. MOST EFFECTIVE BILE ACID IN AIDING ABSORPTION OF FATS & FAT-SOLUABLE VITAMINS.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 154


4.2 Drug Indication

For improvement in appearance of moderate to severe fullness associated with submental fat in adults.


FDA Label


Investigated for use/treatment in solid tumors.


Treatment of localised fat deposits


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Cholagogues and Choleretics

Gastrointestinal agents that stimulate the flow of bile into the duodenum (cholagogues) or stimulate the production of bile by the liver (choleretic). (See all compounds classified as Cholagogues and Choleretics.)


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
DEOXYCHOLIC ACID
5.2.2 FDA UNII
005990WHZZ
5.2.3 Pharmacological Classes
Decreased Cell Membrane Integrity [PE]; Cytolytic Agent [EPC]
5.3 ATC Code

D - Dermatologicals

D11 - Other dermatological preparations

D11A - Other dermatological preparations

D11AX - Other dermatologicals

D11AX24 - Deoxycholic acid


5.4 Absorption, Distribution and Excretion

Absorption

Deoxycholic acid is rapidly absorbed after subcutaneous administration. After maximum recommended single treatment dose, 100mg, the post-treatment plasma levels returned to endogenous levels within 24 hours. With the proposed treatment guideline, no accumulation is expected.


Route of Elimination

The exogenous deoxycholic acid joins the endogenous bile acid pool in the enterohepatic circulation and is excreted unchanged in feces along with endogenous deoxycholic acid.


LIVER NORMALLY SECRETES APPROX 24 G OF BILE SALTS IN 700 TO 1000 ML OF BILE IN 24 HR. MOST OF BILE SALTS ARE REABSORBED IN LOWER SMALL INTESTINE & AGAIN BECOME AVAILABLE FOR SECRETION. ... POOL OF BILE SALTS IS APPROX 2 TO 5 G. /BILE SALTS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 971


5.5 Metabolism/Metabolites

Deoxycholic acid is not metabolized to any significant extent under normal conditions.


5.6 Mechanism of Action

As a bile acid, deoxycholic acid emulsifies fat in the gut. Synthetically derived deoxycholic acid, when injected, stimulates a targeted breakdown of adipose cells by disrupting the cell membrane and causing adipocytolysis. This results in an inflammatory reaction and clearing of the adipose tissue remnants by macrophages. Deoxycholic acid's actions are reduced by albumin and tissue-associated proteins, therefore its effect is limited to protein-poor subcutaneous fat tissue. Protein-rich tissues like muscle and skin are unaffected by deoxycholic acid, contributing to its safety profile.


IN SOLN CONJUGATED BILE SALTS FORM MICELLES IN WHICH LIPID MATERIALS MAY BE ENTRAINED. ...ALSO PROMOTE DIGESTION OF FATS BY STIMULATING PANCREATIC SECRETION & BY ACTIVATING PANCREATIC LIPASE. ... DEOXYCHOLIC.../ACID/ PROMOTE/S/ NET EXCRETION OF NA, K, & WATER IN COLON...MAY BE...FACTORS REGULATING COLONIC ABSORPTION.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 971


DEOXYCHOLATE ADMIN DECR ABSORPTION OF CHOLESTEROL FROM HUMAN INTESTINAL TRACT. IT APPEARED TO INFLUENCE INTESTINAL FLORA AS ASSESSED INDIRECTLY BY ANALYSIS OF TYPES OF NEUTRAL STEROLS ELIM WITH FECES.

PMID:377936 GALLO-TORRES ET AL; AM J CLIN NUTR 32 (7): 1363-1365 (1979)


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GDUFA

DMF Review : Complete

Rev. Date : 2018-02-08

Pay. Date : 2018-01-03

DMF Number : 32305

Submission : 2017-12-29

Status : Active

Type : II

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MAHARASHTRA","supplier":"PHARMAZELL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"510.00","actualQuantity":"510","unit":"KGS","unitRateFc":"270","totalValueFC":"155608.6","currency":"EUR","unitRateINR":"25569","date":"27-Sep-2024","totalValueINR":"13040190","totalValueInUsd":"155608.6","indian_port":"Bombay Air","hs_no":"29182190","bill_no":"5837084","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"ROSENHEIMER STR.43,83064 RAUBLING SDNF SDNF GERMANY","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"URSODIOL (URSODEOXYCHOLIC ACID) \\\"C\\\"EP_IN (BATCH NO.2R020M9-1132434) (LIST 3 SR.NO 47)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"PHARMAZELL","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"453.41","actualQuantity":"453.41","unit":"KGS","unitRateFc":"270","totalValueFC":"138342.1","currency":"EUR","unitRateINR":"25569","date":"27-Sep-2024","totalValueINR":"11593240.29","totalValueInUsd":"138342.1","indian_port":"Bombay Air","hs_no":"29182190","bill_no":"5837084","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"ROSENHEIMER STR.43,83064 RAUBLING SDNF SDNF GERMANY","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727893800,"product":"(FOC)URSODEOXYCHOLIC ACID LD","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"ICE PHARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"313.3","totalValueFC":"17853.8","currency":"EUR","unitRateINR":"30003.8","date":"03-Oct-2024","totalValueINR":"1500190.05","totalValueInUsd":"17853.8","indian_port":"Bangalore Air","hs_no":"29181990","bill_no":"5930155","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA SICILIA 8\/10 42122 REGGIO EMILI A - ITALIA SDNF Italy","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728930600,"product":"URSODEOXYCHOLIC ACID 2612 BATCH NO.2024090395 CAS NO.81-23-2","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"ICE PHARMA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"390","totalValueFC":"118146.6","currency":"USD","unitRateINR":"33091.5","date":"15-Oct-2024","totalValueINR":"9927450","totalValueInUsd":"118146.6","indian_port":"Madras Air","hs_no":"29419019","bill_no":"6126876","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA NOVI 78 15060 BASALUZZO AL SDNF ITALY","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729276200,"product":"2618 URSODEOXYCHOLIC ACID LD","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"N\/A","supplierCountry":"ITALY","foreign_port":"TORINO","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"740.00","actualQuantity":"740","unit":"KGS","unitRateFc":"388.6","totalValueFC":"290724.3","currency":"USD","unitRateINR":"33011.6","date":"19-Oct-2024","totalValueINR":"24428562","totalValueInUsd":"290724.3","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"6222347","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"TORINO","supplierAddress":"N\/A","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729535400,"product":"URSODDEOXYCHOLIC ACID LDB.N 2410586,2410681","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"DIAPHARMA FRANCIS S.R.L.","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"615.50","actualQuantity":"615.5","unit":"KGS","unitRateFc":"404.8","totalValueFC":"251920","currency":"USD","unitRateINR":"34391.5","date":"22-Oct-2024","totalValueINR":"21167968.25","totalValueInUsd":"251920","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29181990","bill_no":"6259086","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"Via Orriggio 23 Coronno Pertusella via Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730745000,"product":"SODIUM DEOXYCHOLATE - DEOXYCHOLIC ACID SODIUM SALT(PO NO. 5100024910) CON","address":"212\/2 HADAPSAR","city":"PUNE, MAHARASHTRA","supplier":"NEW ZEALAND PHARMACEUTICALS LTD","supplierCountry":"NEW ZEALAND","foreign_port":"AUCKLAND","customer":"SERUM INSTITUTE OF INDIA","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"674","totalValueFC":"67848.7","currency":"USD","unitRateINR":"57256.3","date":"05-Nov-2024","totalValueINR":"5725630","totalValueInUsd":"67848.7","indian_port":"Hadapsar,SEZ,Pune","hs_no":"29181990","bill_no":"6496114","productDescription":"API","marketType":"REGULATED MARKET","country":"NEW ZEALAND","selfForZScoreResived":"Pharma Grade","supplierPort":"AUCKLAND","supplierAddress":"68 WELD STREET RD2 PALMERSTON NORTH SDNF New Zealand","customerAddress":"212\/2 HADAPSAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"URSODEOXYCHOLIC ACID LD","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"DIAPHARMA FRANCIS S.R.L.","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"310.70","actualQuantity":"310.7","unit":"KGS","unitRateFc":"400.6","totalValueFC":"125668.9","currency":"USD","unitRateINR":"34132.5","date":"13-Nov-2024","totalValueINR":"10604967.75","totalValueInUsd":"125668.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29181990","bill_no":"6649281","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"Via Orriggio 23 Coronno Pertusella via Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731695400,"product":"URSODEOXYCHOLIC ACID","address":"MEDREICH HOUSE, NO12\/8,","city":"SEVA NAGAR, BANGALORE, KARNATAKA","supplier":"PHARMAZELL","supplierCountry":"GERMANY","foreign_port":"MILAN - MALPENSA","customer":"MEDREICH","customerCountry":"INDIA","quantity":"907.16","actualQuantity":"907.16","unit":"KGS","unitRateFc":"268","totalValueFC":"261591.1","currency":"EUR","unitRateINR":"24334.4","date":"16-Nov-2024","totalValueINR":"22075194.3","totalValueInUsd":"261591.1","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"6702336","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"ROSENHEIMER STRASSE 43 RAUBLING 83064 SDNF GERMANY","customerAddress":"MEDREICH HOUSE, NO12\/8,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"URSODEOXYCHOLIC ACID LD","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"DIAPHARMA FRANCIS S.R.L.","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"632.90","actualQuantity":"632.9","unit":"KGS","unitRateFc":"393.9","totalValueFC":"251965.5","currency":"USD","unitRateINR":"33596","date":"18-Nov-2024","totalValueINR":"21262908.4","totalValueInUsd":"251965.5","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29181990","bill_no":"6736442","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"Via Orriggio 23 Coronno Pertusella via Italy SDNF Italy","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"2612 URSODEOXYCHOLIC ACID","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"ICE PHARMA","supplierCountry":"ITALY","foreign_port":"MILAN - 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(VA) Italy SDNF Italy","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
02-Jan-2021
21-Nov-2024
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ABOUT THIS PAGE

Deoxycholic Acid Manufacturers

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

Deoxycholic Acid Suppliers

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

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

Deoxycholic Acid USDMF

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

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

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

Deoxycholic Acid KDMF

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

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

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

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

Deoxycholic Acid CEP

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

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

Deoxycholic Acid WC

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

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

Deoxycholic Acid 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 Deoxycholic Acid as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Deoxycholic Acid GMP

Deoxycholic Acid 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 Deoxycholic Acid 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 Deoxycholic Acid GMP manufacturer or Deoxycholic Acid GMP API supplier for your needs.

Deoxycholic Acid CoA

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

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

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