Synopsis
0
JDMF
0
VMF
0
FDF
0
Australia
0
South Africa
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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
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
| Molecular Weight | 392.6 g/mol |
|---|---|
| Molecular Formula | C24H40O4 |
| XLogP3 | 4.9 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 4 |
| Exact Mass | 392.29265975 g/mol |
| Monoisotopic Mass | 392.29265975 g/mol |
| Topological Polar Surface Area | 77.8 Ų |
| Heavy Atom Count | 28 |
| Formal Charge | 0 |
| Complexity | 605 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 10 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
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
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
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.)
D - Dermatologicals
D11 - Other dermatological preparations
D11A - Other dermatological preparations
D11AX - Other dermatologicals
D11AX24 - Deoxycholic acid
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
Deoxycholic acid is not metabolized to any significant extent under normal conditions.
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)
API SUPPLIERS
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Certificate Number : R1-CEP 2001-331 - Rev 03
Issue Date : 2020-06-05
Type : TSE
Substance Number :
Status : Valid
Registrant Name : Penmix Co., Ltd.
Registration Date : 2024-09-04
Registration Number : 20240904-210-J-1687
Manufacturer Name : ICE SPA
Manufacturer Address : Via Novi 78-15060 Basaluzzo (Al), Italy
ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.
Certificate Number : R1-CEP 2000-335 - Rev 03
Issue Date : 2017-03-14
Type : TSE
Substance Number :
Status : Valid
Registrant Name : Penmix Co., Ltd.
Registration Date : 2024-09-04
Registration Number : 20240904-210-J-1687
Manufacturer Name : ICE SPA
Manufacturer Address : Via Novi 78-15060 Basaluzzo (Al), Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33526
Submission : 2019-01-16
Status : Active
Type : II
NDC Package Code : 65089-0054
Start Marketing Date : 2015-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-07-07
Registration Number : 20200707-210-J-659
Manufacturer Name : Curia Spain SAU
Manufacturer Address : Parque Tecnológico Boecillo, Parcela 105, Boecillo, 47151 Valladolid, Spain
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-02-08
Pay. Date : 2018-01-03
DMF Number : 32305
Submission : 2017-12-29
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-937
Start Marketing Date : 2017-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 65089-0054
Start Marketing Date : 2015-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 66039-937
Start Marketing Date : 2017-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50384-0151
Start Marketing Date : 2015-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
Details:
Under the terms of the definitive agreement, PDL BioPharma will sale three royalty interests for Kybella®, Zalviso®, and Coflex® (collectively the "Royalties") to SWK Funding, LLC a wholly owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH).
Lead Product(s): Deoxycholic Acid
Therapeutic Area: Nutrition and Weight Loss Brand Name: Kybella
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: SWK Holdings Corporation
Deal Size: $4.3 million Upfront Cash: $4.3 million
Deal Type: Divestment August 31, 2020
Lead Product(s) : Deoxycholic Acid
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved
Partner/Sponsor/Collaborator : SWK Holdings Corporation
Deal Size : $4.3 million
Deal Type : Divestment
PDL BioPharma Announces Sale of Kybella®, Zalviso® and Coflex® Royalties to SWK Holdings Corpor...
Details : Under the terms of the definitive agreement, PDL BioPharma will sale three royalty interests for Kybella®, Zalviso®, and Coflex® (collectively the "Royalties") to SWK Funding, LLC a wholly owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH).
Product Name : Kybella
Product Type : Small molecule
Upfront Cash : $4.3 million
August 31, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : RX
Registration Country : USA
Brand Name : KYBELLA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 20MG/2ML (10MG/ML)
Packaging :
Approval Date : 2015-04-29
Application Number : 206333
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : BELKYRA
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 4X2ML
Approval Date :
Application Number : 2443910
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Norway
Brand Name : Belkyra
Dosage Form : Injection fluid, resolution
Dosage Strength : 10 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Generic
Registration Country : Egypt
Brand Name :
Dosage Form : Injection
Dosage Strength : 20MG/2ML
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Egypt
Regulatory Info : RX
Registration Country : USA
Brand Name : DEOXYCHOLIC ACID
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 20MG/2ML (10MG/ML)
Packaging :
Approval Date : 2021-04-02
Application Number : 212296
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code : AP
Brand Name : KYBELLA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 20MG/2ML (10MG/ML)
Approval Date : 2015-04-29
Application Number : 206333
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : No
TE Code : AP
Brand Name : DEOXYCHOLIC ACID
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 20MG/2ML (10MG/ML)
Approval Date : 2021-04-02
Application Number : 212296
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Norway
Brand Name : Belkyra
Dosage Form : Injection fluid, resolution
Dosage Strength : 10 mg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info :
Registration Country : Canada
Brand Name : BELKYRA
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 4X2ML
Approval Date :
Application Number : 2443910
Regulatory Info :
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Parenteral
Topical
Solubilizers
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Health Canada Patents
Patent Expiration Date : 2032-09-21
Date Granted : 2015-06-02
Brand Name : BELKYRA
Patent Number : 2849369
Filing Date : 2012-09-21
Strength per Unit : 10 mg / mL
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2032-09-21
Date Granted : 2015-06-02
Patent Expiration Date : 2025-05-19
Date Granted : 2013-07-09
Brand Name : BELKYRA
Patent Number : 2567298
Filing Date : 2005-05-19
Strength per Unit : 10 mg / mL
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2025-05-19
Date Granted : 2013-07-09
Patent Expiration Date : 2028-06-18
Date Granted : 2015-10-06
Brand Name : BELKYRA
Patent Number : 2789109
Filing Date : 2008-06-18
Strength per Unit : 10 mg / mL
Dosage Form : SOLUTION
Human Or VET : Human
Route of Administration : SUBCUTANEOUS
Patent Expiration Date : 2028-06-18
Date Granted : 2015-10-06
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
Deoxycholic Acid (Desoxycholic Acid) (100 mg)
CAS Number : 83-44-3
Quantity Per Vial :
Price ($) : 255
Catalog Number : 1171273
Current Lot : F05420
Previous Lot :
NDC Code :
ABOUT THIS PAGE
73
PharmaCompass offers a list of Deoxycholic Acid 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 Deoxycholic Acid manufacturer or Deoxycholic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Deoxycholic Acid manufacturer or Deoxycholic Acid supplier.
PharmaCompass also assists you with knowing the Deoxycholic Acid API Price utilized in the formulation of products. Deoxycholic Acid API Price is not always fixed or binding as the Deoxycholic Acid Price is obtained through a variety of data sources. The Deoxycholic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
