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1. Acid, Bichloroacetic
2. Acid, Dichloroacetic
3. Bichloroacetic Acid
4. Dichloroacetate, Potassium
5. Dichloroacetate, Sodium
6. Dichloroacetic Acid
7. Potassium Dichloroacetate
1. 2156-56-1
2. Sodium 2,2-dichloroacetate
3. Dichloroacetic Acid Sodium Salt
4. Ceresine
5. Dichloroacetate Sodium
6. Acetic Acid, Dichloro-, Sodium Salt
7. Dca Sodium
8. Cpc-211
9. Dca
10. Sodium Dichloroacetate [usan]
11. Bichloroacetic Acid
12. Cmi X-11s
13. Sodium Dichloroacetate (dca)
14. Nsc-744479
15. Ncgc00167845-01
16. 42932x67b5
17. Dsstox_cid_17207
18. Dsstox_rid_79307
19. Dsstox_gsid_37207
20. Sodium Dichloroacetate (usan)
21. Cas-2156-56-1
22. Mfcd00070489
23. Dichloroctan Sodny [czech]
24. Sodium,2,2-dichloroacetate
25. Cpc 211
26. Ccris 7697
27. Dichloroacetic Acid, Sodium Salt
28. Dichloroctan Sodny
29. Ceresine (tn)
30. Einecs 218-461-3
31. Sodium?dichloroacetate
32. Dichloroacetate Sodium Salt
33. Schembl105849
34. Chembl306823
35. Dtxsid8037207
36. Hy-y0445a
37. Hms3269p21
38. Hms3413f08
39. Hms3677f08
40. Hms3867g13
41. Unii-42932x67b5
42. Amy37987
43. Tox21_113573
44. Tox21_301394
45. Bdbm50177027
46. S8615
47. Akos015833467
48. Sodium Dichloroacetate [mart.]
49. Ccg-266211
50. Nsc 744479
51. Ncgc00255419-01
52. As-58721
53. B7174
54. Cs-0030662
55. D1048
56. D1719
57. Ft-0624702
58. D05857
59. F12025
60. 3-(1,3-benzothiazol-2-yl)propanoicacid
61. A815488
62. J-014151
63. Q27258517
| Molecular Weight | 150.92 g/mol |
|---|---|
| Molecular Formula | C2HCl2NaO2 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 1 |
| Exact Mass | 149.9251289 g/mol |
| Monoisotopic Mass | 149.9251289 g/mol |
| Topological Polar Surface Area | 40.1 Ų |
| Heavy Atom Count | 7 |
| Formal Charge | 0 |
| Complexity | 64.7 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7557
Submission : 1988-06-22
Status : Inactive
Type : II
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NDC Package Code : 57419-0003
Start Marketing Date : 2019-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
Details:
Dichloroacetate (SL-1009) has the potential to be the 1st approved medication for the mitochondrial disease PDCD. DCA inhibits PDKs to stimulate residual PDC activity and increase energy (ATP) production by mitochondria.
Lead Product(s): Dichloroacetic Acid
Therapeutic Area: Rare Diseases and Disorders Brand Name: SL-1009
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2022
Lead Product(s) : Dichloroacetic Acid
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Dichloroacetate (SL-1009) has the potential to be the 1st approved medication for the mitochondrial disease PDCD. DCA inhibits PDKs to stimulate residual PDC activity and increase energy (ATP) production by mitochondria.
Brand Name : SL-1009
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 04, 2022
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ABOUT THIS PAGE
A Sodium Dichloroacetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Dichloroacetate, including repackagers and relabelers. The FDA regulates Sodium Dichloroacetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Dichloroacetate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Sodium Dichloroacetate supplier is an individual or a company that provides Sodium Dichloroacetate active pharmaceutical ingredient (API) or Sodium Dichloroacetate finished formulations upon request. The Sodium Dichloroacetate suppliers may include Sodium Dichloroacetate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Dichloroacetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Dichloroacetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Dichloroacetate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Dichloroacetate DMFs exist exist since differing nations have different regulations, such as Sodium Dichloroacetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Dichloroacetate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Dichloroacetate USDMF includes data on Sodium Dichloroacetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Dichloroacetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Dichloroacetate suppliers with USDMF 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 Sodium Dichloroacetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Dichloroacetate 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 Sodium Dichloroacetate 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 Sodium Dichloroacetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Dichloroacetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Dichloroacetate suppliers with NDC on PharmaCompass.
Sodium Dichloroacetate 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 Sodium Dichloroacetate 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 Sodium Dichloroacetate GMP manufacturer or Sodium Dichloroacetate GMP API supplier for your needs.
A Sodium Dichloroacetate CoA (Certificate of Analysis) is a formal document that attests to Sodium Dichloroacetate's compliance with Sodium Dichloroacetate specifications and serves as a tool for batch-level quality control.
Sodium Dichloroacetate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Dichloroacetate 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.
Sodium Dichloroacetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Dichloroacetate EP), Sodium Dichloroacetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Dichloroacetate USP).
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