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Chemistry

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Also known as: 459789-99-2, 6-ecdca, Int-747, 6-ethylchenodeoxycholic acid, Ocaliva, Obetichloic acid
Molecular Formula
C26H44O4
Molecular Weight
420.6  g/mol
InChI Key
ZXERDUOLZKYMJM-ZWECCWDJSA-N
FDA UNII
0462Z4S4OZ

Obeticholic Acid
Obeticholic Acid is an orally bioavailable semi-synthetic bile acid derivative and an agonist of the nuclear bile acid receptor farnesoid X receptor (FXR) that may be used to lower hepatic exposure to bile acids. Upon oral administration, obeticholic acid targets and binds to FXR expressed in the liver and intestine, activating FXR-mediated bile acid, inflammatory, fibrotic, and metabolic pathways. This suppresses the production of bile acid in the hepatocytes and increases bile acid transport out of the hepatocytes, thereby reducing hepatic exposure to bile acids. FXR plays an important role in bile acid homeostasis and is involved in hepatic and intestinal inflammation and liver fibrosis.
Obeticholic acid is a Farnesoid X Receptor Agonist. The mechanism of action of obeticholic acid is as a Farnesoid X Receptor Agonist.
1 2D Structure

Obeticholic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R)-4-[(3R,5S,6R,7R,8S,9S,10S,13R,14S,17R)-6-ethyl-3,7-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/C26H44O4/c1-5-17-21-14-16(27)10-12-26(21,4)20-11-13-25(3)18(15(2)6-9-22(28)29)7-8-19(25)23(20)24(17)30/h15-21,23-24,27,30H,5-14H2,1-4H3,(H,28,29)/t15-,16-,17-,18-,19+,20+,21+,23+,24-,25-,26-/m1/s1
2.1.3 InChI Key
ZXERDUOLZKYMJM-ZWECCWDJSA-N
2.1.4 Canonical SMILES
CCC1C2CC(CCC2(C3CCC4(C(C3C1O)CCC4C(C)CCC(=O)O)C)C)O
2.1.5 Isomeric SMILES
CC[C@@H]1[C@@H]2C[C@@H](CC[C@@]2([C@H]3CC[C@]4([C@H]([C@@H]3[C@@H]1O)CC[C@@H]4[C@H](C)CCC(=O)O)C)C)O
2.2 Other Identifiers
2.2.1 UNII
0462Z4S4OZ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 6-ecdca

2. 6-ethyl Chenodeoxycholic Acid

3. 6-ethyl-3,7-dihydroxycholan-24-oic Acid

4. 6-ethylchenodeoxycholic Acid

5. 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic Acid

6. 6alpha-ethyl-chenodeoxycholic Acid

7. 6ecdca

8. Cholan-24-oic Acid, 6-ethyl-3,7-dihydroxy-, (3alpha,5beta,6alpha,7alpha)-

9. Dsp-1747

10. Dsp1747

11. Int 747

12. Int-747

13. Int747

14. Ocaliva

2.3.2 Depositor-Supplied Synonyms

1. 459789-99-2

2. 6-ecdca

3. Int-747

4. 6-ethylchenodeoxycholic Acid

5. Ocaliva

6. Obetichloic Acid

7. 6alpha-ethyl-chenodeoxycholic Acid

8. Int747

9. Int 747

10. Dsp-1747

11. 6-ethyl-cdca

12. (4r)-4-[(3r,5s,6r,7r,8s,9s,10s,13r,14s,17r)-6-ethyl-3,7-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

13. 6-ethyl-chenodeoxycholic Acid

14. 6alpha-ethylchenodeoxycholic Acid

15. 0462z4s4oz

16. 6alpha-ethyl-3alpha,7alpha-dihydroxy-5beta-cholan-24-oic Acid

17. 6ecdca

18. (4r)-4-[(1s,2s,5r,7s,8r,9r,10s,11s,14r,15r)-8-ethyl-5,9-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic Acid

19. Unii-0462z4s4oz

20. 6-et Cdca

21. Obeticholic Acid [usan]

22. Obeticholic Acid [usan:inn]

23. 1osv

24. Dsp1747

25. Ocaliva (tn)

26. 6-ethyl-3,7-dihydroxycholan-24-oic Acid

27. 6-ecdca; Obeticholic Acid

28. Obeticholic Acid [mi]

29. Schembl715823

30. Obeticholic Acid (int-747)

31. Obeticholic Acid [inn]

32. Obeticholic Acid [jan]

33. Chembl566315

34. Gtpl3435

35. (3alpha,5beta,6alpha,7alpha)-6-ethyl-3,7-dihydroxycholan-24-oic Acid

36. Bdbm21675

37. Chebi:43602

38. Dtxsid20196671

39. Ex-a387

40. 6-alpha-ethylchenodeoxycholic Acid

41. Obeticholic Acid [who-dd]

42. Obeticholic Acid (jan/usan/inn)

43. Amy16595

44. Mfcd16621104

45. Zinc14164617

46. Akos024259126

47. Cholan-24-oic Acid, 6-ethyl-3,7-dihydroxy-, (3alpha,5beta,6alpha,7alpha)-

48. Obeticholic Acid [orange Book]

49. Cs-3813

50. Db05990

51. Gs-6103

52. Ncgc00480885-01

53. Hy-12222

54. D09360

55. P16663

56. A854341

57. Q15708271

58. 3a, 7a -dihydroxy-6a -ethyl-5b-cholan-24-oic Acid

59. 3alpha,7alpha-dihydroxy-6alpha-ethyl-5beta-cholan-24-oic Acid

60. (3alpha,5beta,6alpha,7alpha,8xi)-6-ethyl-3,7-dihydroxycholan-24-oic Acid

61. (3beta,5beta,6alpha,7beta)-6-ethyl-3,7-dihydroxycholan-24-oic Acid

62. (3.alpha.,5.beta.,6.alpha.,7.alpha.)-6-ethyl-3,7-dihydroxycholan-24-oic Acid

63. (r)-4-((3r,5s,6r,7r,8s,9s,10s,13r,14s,17r)-6-ethyl-3,7-dihydroxy-10,13-dimethyl-hexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)pentanoic Acid

64. (r)-4-((3r,7r,8s,9s,10s,13r,14s,17r)-6-ethyl-3,7-dihydroxy-10,13-dimethyl-hexadecahydro-1h-cyclopenta[a]phenanthren-17-yl)pentanoic Acid

65. Cholan-24-oic Acid, 6-ethyl-3,7-dihydroxy-, (3.alpha.,5.beta.,6.alpha.,7.alpha.)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 420.6 g/mol
Molecular Formula C26H44O4
XLogP35.7
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass420.32395988 g/mol
Monoisotopic Mass420.32395988 g/mol
Topological Polar Surface Area77.8 Ų
Heavy Atom Count30
Formal Charge0
Complexity649
Isotope Atom Count0
Defined Atom Stereocenter Count11
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Obeticholic acid is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA. It is also used as a monotherapy in adults with PBC that are unable to tolerate UDCA. Obeticholic acid is currently being considered for FDA approval to treat fibrosis caused by non-alcoholic liver steatohepatitis (NASH), and is likely to be approved for this indication in 2020.


FDA Label


Ocaliva is indicated for the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.


Treatment of non-alcoholic steatohepatitis (NASH)


Treatment of biliary atresia, Treatment of primary biliary cirrhosis


5 Pharmacology and Biochemistry
5.1 Pharmacology

The activation of the FXR by obeticholic acid acts to reduce the synthesis of bile acids, inflammation, and the resulting hepatic fibrosis. This may increase the survival of patients with PBC, but to date, an association between obeticholic acid and survival in PBC has not been established.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
OBETICHOLIC ACID
5.2.2 FDA UNII
0462Z4S4OZ
5.2.3 Pharmacological Classes
Farnesoid X Receptor Agonists [MoA]; Farnesoid X Receptor Agonist [EPC]
5.3 ATC Code

A05AA04


A05AA04

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


A - Alimentary tract and metabolism

A05 - Bile and liver therapy

A05A - Bile therapy

A05AA - Bile acids and derivatives

A05AA04 - Obeticholic acid


5.4 Absorption, Distribution and Excretion

Absorption

Obeticholic acid is absorbed in the gastrointestinal tract. The Cmax of obeticholic acid occurs at approximately 1.5 hours after an oral dose and ranges from 28.8-53.7 ng/mL at doses of 5-10mg. The median Tmax for both the conjugates of obeticholic acid is about 10 hours. One product monograph reports a Tmax of 4.5h for both 5 and 10mg doses. The AUC ranged from 236.6-568.1 ng/h/mL with 5mg to 10 mg doses.


Route of Elimination

About 87% of an orally administered dose is accounted for in the feces. Less than 3% of the dose can be recovered in the urine.


Volume of Distribution

The volume of distribution of obeticholic acid is 618 L.


Clearance

Clearance information for obeticholic acid is not readily available in the literature.


5.5 Metabolism/Metabolites

The metabolism of obeticholic acid occurs in the liver. Obeticholic acid is conjugated with glycine or taurine, followed by secretion into bile. The conjugates are then absorbed in the small intestine and then re-enter the liver via enterohepatic circulation. The intestinal microbiota in the ileum converts conjugated obeticholic acid in a deconjugated form that may be either reabsorbed or eliminated. Glycine conjugates account for 13.8% of the metabolites and taurine conjugates account for 12.3%. Another metabolite, 3-glucuronide, may also be formed, but displays little pharmacological activity.


5.6 Biological Half-Life

The biological half-life of obeticholic acid is reported to be 24 hours.


5.7 Mechanism of Action

Primary biliary cirrhosis is an autoimmune process by which the bile ducts and liver are damaged progressively, leading to fibrosis and cirrhosis. Bile acids increase the risk of damage and fibrosis to the damaged bile ducts. Obeticholic acid is a potent agonist of the farnesoid X receptor, which serves to regulate the hepatic metabolism of bile and cholesterol. This drug acts by binding to the farnesoid X receptor (FXR), found in the nucleus of liver and intestinal cells, which in turn increases liver bile flow, suppressing its production and decreasing hepatocyte exposure to excess levels of bile with cholestasis. Cholestasis is a process that normally causes inflammation and cirrhosis of the liver.


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Contac","city":"NAVI MUMBAI","supplier":"SOLARA ACTIVE PHARMA SCIENCES","supplierCountry":"INDIA","foreign_port":"LISBON","customer":"M\/S.","customerCountry":"PORTUGAL","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"10000","totalValueFC":"4314.3","currency":"USD","unitRateINR":710000,"date":"12-Oct-2022","totalValueINR":"355000","totalValueInUsd":"4314.3","indian_port":"MADRAS AIR","hs_no":"29420090","bill_no":"4757527","productDescription":"API","marketType":"REGULATED MARKET","country":"PORTUGAL","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRAS AIR","supplierAddress":"NO.201, DEVAVRATA SECTOR 17, VASHI, NAVI MUMBAI - 400705. Contac, NAVI MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665945000,"product":"OBETICHOLIC ACID","address":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL E SANATH NAGAR,HYDERABAD","city":"HYDERABAD TS","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"TO THE ODRER OF","customerCountry":"CANADA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"15000","totalValueFC":"58844.8","currency":"USD","unitRateINR":1210500,"date":"17-Oct-2022","totalValueINR":"4842000","totalValueInUsd":"58844.8","indian_port":"HYDERABAD AIR","hs_no":"29372900","bill_no":"4874614","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL E SANATH NAGAR,HYDERABAD, HYDERABAD TS","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671820200,"product":"OBETICHOLIC ACID","address":"H.NO.4-7-101, SCIENTIST COLONY, HABSIGUDA, NACHARAM, CONTACT NO: 91","city":"HYDERABAD","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"M\/S. TO THE ORDER OF","customerCountry":"EGYPT","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"5000","totalValueFC":"59243.1","currency":"USD","unitRateINR":406833.33333333331,"date":"24-Dec-2022","totalValueINR":"4882000","totalValueInUsd":"59243.1","indian_port":"HYDERABAD AIR","hs_no":"29372900","bill_no":"6417494","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"H.NO.4-7-101, SCIENTIST COLONY, HABSIGUDA, NACHARAM, CONTACT NO: 91, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683829800,"product":"PHARMACEUTICAL FOR PHARMACEUTICAL RAW MATERIAL OBETICHOLIC ACID IN HOUSE","address":"H.NO.4-7-101, SCIENTIST COLONY, HABSIGUDA, NACHARAM, Contact No: 91","city":"HYDERABAD","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER","customerCountry":"EGYPT","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"5000","totalValueFC":"29167.2","currency":"USD","unitRateINR":400000,"date":"12-May-2023","totalValueINR":"2400000","totalValueInUsd":"29167.2","indian_port":"HYDERABAD AIR","hs_no":"29372900","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"H.NO.4-7-101, SCIENTIST COLONY, HABSIGUDA, NACHARAM, Contact No: 91, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699641000,"product":"PHARMACEUTICAL ALLOPATHIC RAW MATERIAL OF PHARMACEUTICAL GRADE OBETICHOLIC ACID","address":"VILL. BHONDSI, TECH, SOHNA,","city":"GURGAON","supplier":"KIMIA BIOSCIENCES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER","customerCountry":"BANGLADESH","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"4600","totalValueFC":"8934.7","currency":"USD","unitRateINR":372000,"date":"11-Nov-2023","totalValueINR":"744000","totalValueInUsd":"8934.7","indian_port":"Delhi Air","hs_no":"29181990","bill_no":"5310645","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"VILL. BHONDSI, TECH, SOHNA,, GURGAON","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700073000,"product":"PHARMACEUTICAL ALLOPATHIC RAW MATERIAL OF PHARMACEUTICAL GRADE OBETICHOLIC ACID","address":"VILL. BHONDSI, TECH, SOHNA,","city":"GURGAON","supplier":"KIMIA BIOSCIENCES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER","customerCountry":"BANGLADESH","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"4600","totalValueFC":"8934.7","currency":"USD","unitRateINR":372000,"date":"16-Nov-2023","totalValueINR":"744000","totalValueInUsd":"8934.7","indian_port":"Delhi Air","hs_no":"29181990","bill_no":"5370304","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"VILL. BHONDSI, TECH, SOHNA,, GURGAON","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702405800,"product":"OBETICHOLIC ACID INN","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"M\/S, COMMERCIAL BANK OF CEYLON PLC,","customerCountry":"BANGLADESH","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"5500","totalValueFC":"16061.4","currency":"USD","unitRateINR":445666.66666666669,"date":"13-Dec-2023","totalValueINR":"1337000","totalValueInUsd":"16061.4","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"6010879","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702405800,"product":"OBETICHOLIC ACID IN HOUSE","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"MARCYRL PHARMACEUTICALS","customerCountry":"EGYPT","quantity":"6.00","actualQuantity":"6","unit":"KGS","unitRateFc":"5000","totalValueFC":"29323.7","currency":"USD","unitRateINR":406833.33333333331,"date":"13-Dec-2023","totalValueINR":"2441000","totalValueInUsd":"29323.7","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"6010733","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708972200,"product":"OBETICHOLIC ACID PHARMACEUTICAL ALLOPATHIC RAW MATERIAL","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"WORLD MEDICINE","customerCountry":"TURKEY","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"25000","totalValueFC":"2417.3","currency":"USD","unitRateINR":2005740,"date":"27-Feb-2024","totalValueINR":"200574","totalValueInUsd":"2417.3","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"7873996","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711477800,"product":"OBETICHOLIC ACID IN-HOUSE","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"MARCYRL PHARMACEUTICALS","customerCountry":"EGYPT","quantity":"12.41","actualQuantity":"12.41","unit":"KGS","unitRateFc":"4250","totalValueFC":"51982.5","currency":"USD","unitRateINR":347816.89202256245,"date":"27-Mar-2024","totalValueINR":"4316407.63","totalValueInUsd":"51982.5","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"8647982","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714674600,"product":"OBETICHOLIC ACID","address":"NO.201, DEVAVRATA SECTOR 17,,VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"SOLARA ACTIVE PHARMA SCIENCES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"M\/S.","customerCountry":"BANGLADESH","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"5000","totalValueFC":"2378.3","currency":"USD","unitRateINR":396480,"date":"03-May-2024","totalValueINR":"198240","totalValueInUsd":"2378.3","indian_port":"Madras Air","hs_no":"29420090","bill_no":"9596615","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Madras Air","supplierAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI, NAVI MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1719772200,"product":"PHARMACEUTICAL RAW MATERIAL : OBETICHOLIC ACID","address":"VILL. BHONDSI, TECH, SOHNA,","city":"GURGAON","supplier":"KIMIA BIOSCIENCES","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER","customerCountry":"BANGLADESH","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"4159.9","totalValueFC":"20627.5","currency":"USD","unitRateINR":344855,"date":"01-Jul-2024","totalValueINR":"1724275","totalValueInUsd":"20627.5","indian_port":"Delhi Air","hs_no":"29181990","bill_no":"2091476","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"VILL. BHONDSI, TECH, SOHNA,, GURGAON","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722364200,"product":"OBETICHOLIC ACID INN (PHARMACEUTICAL RAWMATERIALS )","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"SHAJALAL ISLAMI BANK PLC.,","customerCountry":"BANGLADESH","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"5200","totalValueFC":"51208.8","currency":"USD","unitRateINR":428060,"date":"31-Jul-2024","totalValueINR":"4280600","totalValueInUsd":"51208.8","indian_port":"Hyderabad Air","hs_no":"29372900","bill_no":"2843002","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1650479400,"product":"OBETICHOLIC ACID","address":"B-4, IDA,","city":"HYDERABAD, TELANGANA.","supplier":"NANJING GREENWAY LIFESCIENCE ","supplierCountry":"CHINA","foreign_port":"GUANGZHOU","customer":"VIRUPAKSHA ORGANICS","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"4600","totalValueFC":"14047.1","currency":"USD","unitRateINR":"353280","date":"21-Apr-2022","totalValueINR":"1059840","totalValueInUsd":"14047.1","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29029090","bill_no":"1006884","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUANGZHOU","supplierAddress":"N\/A","customerAddress":"B-4, IDA,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1656613800,"product":"OBETICHOLIC ACID (ORGANIC CHEMICALS) (FOR LABORATORY ANALYTICAL TESTING PURPOSE","address":"17 LOTUS BUSINESS PARK,NEW LINK RD ANDHERI W","city":"MUMBAI,MAHARASHTRA","supplier":"BEIJING MESOCHEM TECHNOLOGY","supplierCountry":"CHINA","foreign_port":"NA","customer":"CLEARSYNTH LABS LIMITED","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"9.4","totalValueFC":"943.8","currency":"USD","unitRateINR":"750.5","date":"01-Jul-2022","totalValueINR":"75047.9","totalValueInUsd":"943.8","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"9355902","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"17 LOTUS BUSINESS PARK,NEW LINK RD ANDHERI W"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1664389800,"product":"PHARMACEUTICALS RAW MATERIAL FOR MFG OF INTERMEDIATE BULK DRUG-OBETICHOLIC ACID","address":"B-4, IDA,","city":"HYDERABAD, TELANGANA.","supplier":"HANGZHOU QICHAUNG CHEMICAL CO;LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"VIRUPAKSHA ORGANICS","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"4400","totalValueFC":"13242.7","currency":"USD","unitRateINR":"353760","date":"29-Sep-2022","totalValueINR":"1061280","totalValueInUsd":"13242.7","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29029090","bill_no":"1017506","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"B-4, IDA,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679855400,"product":"PHARMACEUTICALS RAW MATERIAL FOR MFG OF INTERMEDIATE BULK DRUG - OBETICHOLIC ACID","address":"B-4, IDA,","city":"HYDERABAD, TELANGANA.","supplier":"HANGZHOU QICHUANG CHEMICAL CO ., LTD","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"VIRUPAKSHA ORGANICS","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"4000","totalValueFC":"20352.5","currency":"USD","unitRateINR":"334800","date":"27-Mar-2023","totalValueINR":"1674000","totalValueInUsd":"20352.5","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29339990","bill_no":"1005351","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"B-4, IDA,"}]
30-Mar-2021
31-Jul-2024
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ABOUT THIS PAGE

Obeticholic Acid Manufacturers

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

Obeticholic Acid Suppliers

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

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

Obeticholic Acid USDMF

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

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

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

Obeticholic Acid WC

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

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

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

Finished drug products

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

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

Obeticholic Acid GMP

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

Obeticholic Acid CoA

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

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

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