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10 API Suppliers
5 USDMF
1 EU WC
1 KDMF
4 NDC API
7 Listed Suppliers
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Chemistry

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Also known as: Migalastat hcl, 75172-81-5, Deoxygalactonojirimycin hydrochloride, Galafold, 1-deoxygalactonojirimycin hydrochloride, Amigal

Molecular Formula

C₆H₁₄ClNO₄

Molecular Weight

199.63 g/mol

InChI Key

ZJIHMALTJRDNQI-OLALXQGDSA-N

FDA UNII

CLY7M0XD20

1 2D Structure

Migalastat

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2R,3S,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol;hydrochloride

2.1.2 InChI

InChI=1S/C6H13NO4.ClH/c8-2-3-5(10)6(11)4(9)1-7-3;/h3-11H,1-2H2;1H/t3-,4+,5+,6-;/m1./s1

2.1.3 InChI Key

ZJIHMALTJRDNQI-OLALXQGDSA-N

2.1.4 Canonical SMILES

C1C(C(C(C(N1)CO)O)O)O.Cl

2.1.5 Isomeric SMILES

C1[C@@H]([C@H]([C@H]([C@H](N1)CO)O)O)O.Cl

2.2 Other Identifiers

2.2.1 UNII

CLY7M0XD20

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-butyl-2-(hydroxylmethyl)piperidine-3,4,5-triol

2. 1-deoxy-galactonojirimycin

3. 1-deoxygalacto-nojirimycin

4. 1-deoxygalactonojirimycin

5. At1001 Deoxyjirimycin

6. Galafold

7. Gr181413a

8. Lucerastat

9. Migalastat

10. Migalastat Hcl

11. N-butyldeoxygalacto-nojirimycin

12. N-butyldeoxygalactonojirimycin

13. Nb-dgj

2.3.2 Depositor-Supplied Synonyms

1. Migalastat Hcl

2. 75172-81-5

3. Deoxygalactonojirimycin Hydrochloride

4. Galafold

5. 1-deoxygalactonojirimycin Hydrochloride

6. Amigal

7. Migalastat Hydrochloride [usan]

8. Migalastat (hydrochloride)

9. Cly7m0xd20

10. 75172-81-5 (hcl)

11. At-1001 (migalastat Hydrochloride)

12. (2r,3s,4r,5s)-2-(hydroxymethyl)piperidine-3,4,5-triol Hydrochloride

13. (2r,3s,4r,5s)-2-(hydroxymethyl)piperidine-3,4,5-triol Hydrochloride.

14. Gr181413a

15. Unii-cly7m0xd20

16. Migalastathcl

17. Galafold (tn)

18. Deoxygalactonojirimycin,hydrochloride

19. Deoxygalactonojirimycin, Hydrochloride

20. 1-deoxygalactonojirimycin Hcl

21. Schembl3802618

22. Chembl2107355

23. Dtxsid801026249

24. (+)-migalastat Hydrochloride

25. Hy-14929a

26. Mfcd00269962

27. Migalastat Hydrochloride (jan/usan)

28. Migalastat Hydrochloride [mi]

29. Migalastat Hydrochloride [jan]

30. 3,4,5-piperidinetriol, 2-(hydroxymethyl)-, Hydrochloride, (2r,3s,4r,5s)-

31. At13690

32. Cs-6380

33. Migalastat Hydrochloride [who-dd]

34. Migalastat Hydrochloride [orange Book]

35. D05031

36. 1,5-dideoxy-1,5-imino-d-galactitol Hydrochloride

37. W-203722

38. Q27275527

39. (+)-(2r,3s,4r,5s)-2-(hydroxymethyl)piperidine-3,4,5-triol Hydrochloride

40. (2r,3s,4r,5s)-2-(hydroxymethyl)-3,4,5-piperidinetriol Hydrochloride

41. (2r,3s,4r,5s)-2-(hydroxymethyl)piperidine-3,4,5-triol;hydrochloride

42. 3,4,5-piperidinetriol, 2-(hydroxymethyl)-, Hydrochloride (1:1), (2r,3s,4r,5s)-

43. 3,4,5-piperidinetriol, 2-(hydroxymethyl)-, Hydrochloride,[2r-(2a,3a,4a,5b)]-

2.4 Create Date

2006-10-26

3 Chemical and Physical Properties

Molecular Formula	C₆H₁₄ClNO₄
Molecular Weight	199.63 g/mol
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	1
Exact Mass	199.0611356 g/mol
Monoisotopic Mass	199.0611356 g/mol
Topological Polar Surface Area	93 Å²
Heavy Atom Count	12
Formal Charge	0
Complexity	132
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Indication

Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (-galactosidase A deficiency) and who have an amenable mutation.

5 Pharmacology and Biochemistry

5.1 ATC Code

A16AX

API SUPPLIERS

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USDMF

01

Metrochem Api Private Ltd

India

Pharmtech & Ingredients

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Digital Content

Migalastat Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37632

Submission : 2023-02-26

Status : Active

Type : II

02

Apitoria Pharma Private Ltd

India

euroPLX 86 Munich

Not Confirmed

03

Lupin Manufacturing Solutions Ltd

India

euroPLX 86 Munich

Not Confirmed

04

Msn Laboratories Private Ltd

India

euroPLX 86 Munich

Not Confirmed

05

Teva Pharmaceutical Industries Ltd

Israel

euroPLX 86 Munich

Not Confirmed

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EU WC

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KDMF

01

CARBOGEN AMCIS AG

Switzerland

American Pharma Summit

Not Confirmed

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API Reference Price

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OF","customerCountry":"ARGENTINA","quantity":"0.70","actualQuantity":"700","unit":"GMS","unitRateFc":"72","totalValueFC":"49744.1","currency":"USD","unitRateINR":5227.1428571428569,"date":"23-Sep-2021","totalValueINR":"3659000","totalValueInUsd":"49744.1","indian_port":"BOMBAY AIR","hs_no":"29333990","bill_no":"4791188","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"SETHNA BUILDING, 4TH FLR,55, MAHARSHI KARVE ROAD, MARINE, LINES, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1672252200,"product":"OTHER ORGANIC COMPOUNDS-MIGALASTAT HYDRO","address":"SETHNA BUILDING 4TH FLOOR 55,MAHAR SHI KARVE ROAD MARINE LINE","city":"MUMBAI,MAHARASHTRA","supplier":"MEGAFINE PHARMA (P) LIMITED","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES, BA","customer":"TO THE ORDER 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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

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7 Listed Suppliers

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DEVELOPMENTS

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers

1 FDA Orange Book

1 Europe

1 Canada

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

26 NEWS #PharmaBuzz

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