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Miglustat

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 3 USDMF, 1 JDMF, 1 EU WC, 5 NDC API, 6 Listed Suppliers, $ API Reference Price

10 API Suppliers
3 USDMF
1 JDMF
1 EU WC
5 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

23 FDF Dossiers, 5 FDA Orange Book, 13 Europe, 2 Canada, 1 South Africa, 2 Listed Dossiers

23 FDF Dossiers
5 FDA Orange Book
13 Europe
2 Canada
1 South Africa
2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

7 DKSH, 1 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 4 ACG Worldwide, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 DFE Pharma, 1 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 3 Lonza Capsugel, 5 Microlex e.U, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 4 Roquette, 1 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Sigachi Industries, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

13 Fillers, Diluents & Binders, 10 Lubricants & Glidants, 9 Disintegrants & Superdisintegrants, 8 Empty Capsules, 7 Thickeners and Stabilizers, 6 Coating Systems & Additives, 4 Co-Processed Excipients, 3 Direct Compression, 3 Coloring Agents, 2 Film Formers & Plasticizers, 1 Granulation, 1 Emulsifying Agents, 1 Taste Masking, 1 API Stability Enhancers, 1 Solubilizers, 1 Controlled & Modified Release

excipientsByApplications
13 Fillers, Diluents & Binders
10 Lubricants & Glidants
9 Disintegrants & Superdisintegrants
8 Empty Capsules
7 Thickeners and Stabilizers
6 Coating Systems & Additives
4 Co-Processed Excipients
3 Direct Compression
3 Coloring Agents
2 Film Formers & Plasticizers
1 Granulation
1 Emulsifying Agents
1 Taste Masking
1 API Stability Enhancers
1 Solubilizers
1 Controlled & Modified Release

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 22 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
22 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 10 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
10 Finished Drug Prices
1 Annual Reports

MARKET PLACE

7 APIs, 4 FDF Dossiers

marketPlace
7 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 US Patents, 1 US Exclusivities, 1 Health Canada Patents

patents
7 US Patents
1 US Exclusivities
1 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 26,958

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

21DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

8,638,741

Annual Reports (USD Million)

103

Finished Drug Prices

48 RELATED EXCIPIENT COMPANIES

71EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 72599-27-0, N-butyldeoxynojirimycin, Zavesca, Butyldeoxynojirimycin, Nb-dnj, N-butylmoranoline

Molecular Formula

C₁₀H₂₁NO₄

Molecular Weight

219.28 g/mol

InChI Key

UQRORFVVSGFNRO-UTINFBMNSA-N

FDA UNII

ADN3S497AZ

Miglustat is a synthetic, N-alkylated imino analogue of D-glucose. Miglustat competitively and reversibly binds to and inhibits the activity of UDP-glucose ceramide glucosyltransferase, which catalyzes the initial step in the synthesis of glycosphingolipids (GSL). This leads to a decrease in the production of glycosphingolipid, which has important roles in various cellular processes. Miglustat can be used in substrate reduction therapy in diseases in which the enzyme glucocerebrosidase, that is responsible for the breakdown of GSL, is deficient.

Miglustat is a Glucosylceramide Synthase Inhibitor. The mechanism of action of miglustat is as a Glucosylceramide Synthase Inhibitor.

1 2D Structure

Miglustat

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2R,3R,4R,5S)-1-butyl-2-(hydroxymethyl)piperidine-3,4,5-triol

2.1.2 InChI

InChI=1S/C10H21NO4/c1-2-3-4-11-5-8(13)10(15)9(14)7(11)6-12/h7-10,12-15H,2-6H2,1H3/t7-,8+,9-,10-/m1/s1

2.1.3 InChI Key

UQRORFVVSGFNRO-UTINFBMNSA-N

2.1.4 Canonical SMILES

CCCCN1CC(C(C(C1CO)O)O)O

2.1.5 Isomeric SMILES

CCCCN1C[C@@H]([C@H]([C@@H]([C@H]1CO)O)O)O

2.2 Other Identifiers

2.2.1 UNII

ADN3S497AZ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Butyldeoxynojirimycin

2. N-(n-butyl)deoxy-nojirimycin

3. N-(n-butyl)deoxynojirimycin

4. N-butyl Deoxynojirimycin

5. N-butyldeoxynojirimycin

6. Ogt 918

7. Ogt-918

8. Sc 48334

9. Sc-48334

10. Zavesca

2.3.2 Depositor-Supplied Synonyms

1. 72599-27-0

2. N-butyldeoxynojirimycin

3. Zavesca

4. Butyldeoxynojirimycin

5. Nb-dnj

6. N-butylmoranoline

7. (2r,3r,4r,5s)-1-butyl-2-(hydroxymethyl)piperidine-3,4,5-triol

8. N-butyl-1-deoxynojirimycin

9. Budnj

10. N-butyl Deoxynojirimycin

11. N-(n-butyl)deoxynojirimycin

12. Ogt 918

13. Sc-48334

14. Ogt-918

15. N-butyl-dnj

16. Sc 48334

17. 3,4,5-piperidinetriol, 1-butyl-2-(hydroxymethyl)-, (2r,3r,4r,5s)-

18. N-butyldeoxynojirimycin.hcl

19. Adn3s497az

20. Chembl1029

21. Chebi:50381

22. 72599-27-0 (free Base)

23. N-butyl Dnj

24. Miglustat [usan]

25. Dsstox_cid_25618

26. Dsstox_rid_81006

27. Dsstox_gsid_45618

28. Miglustatum

29. Vevesca

30. Zavesca (tn)

31. Cas-72599-27-0

32. N-bu-dnj

33. N-butyl-deoxynojirimycin

34. Nbv

35. Unii-adn3s497az

36. Sc48334

37. Brazaves

38. N-(n-butyl)deoxy-nojirimycin

39. Miglustat [usan:inn:ban]

40. D-glucitol, 1,5-(butylimino)-1,5-dideoxy-

41. Ncgc00018140-02

42. Brazaves (tn)

43. Mfcd00272581

44. Miglustat [inn]

45. Miglustat [jan]

46. Miglustat [mi]

47. 1,5-dideoxy-1,5-n-butylimino-d-glucitol

48. Miglustat [vandf]

49. Miglustat [mart.]

50. Miglustat [who-dd]

51. N-(n-butyl)-1,5-dideoxy-1,5-imino-d-glucitol

52. Miglustat [ema Epar]

53. Miglustat (jan/usan/inn)

54. Schembl246893

55. Ogt918n-butyldeoxynojirimycin

56. Gtpl4841

57. Ogt918

58. Miglustat [orange Book]

59. Dtxsid6045618

60. Bdbm18355

61. Hms2090n20

62. Zinc3794711

63. Tox21_110830

64. Akos028109118

65. Tox21_110830_1

66. Db00419

67. 3,4,5-piperidinetriol, 1-butyl-2-(hydroxymethyl)-, (2r-(2alpha,3beta,4alpha,5beta))-

68. Ncgc00024452-03

69. Ncgc00024452-04

70. Hy-17020

71. N-(n-butyl)-1-deoxynojirimycin Min. 99%

72. N-butyldeoxynojirimycin, Film (dried In Situ)

73. D05032

74. P16976

75. Ab00489939-10

76. 1,5-(butylimino)-1,5 Dideoxy,d-glucitol

77. A850985

78. Q425911

79. Sr-01000000043

80. Sr-01000000043-2

81. W-203639

82. 1,5-(butylimino)-1,5-dideoxy-d-glucitol(2r,3r,4r,5s)-1-butyl-2-(hydroxymethyl)-3,4,5-piperidinetriol

83. 134282-77-2

2.4 Create Date

2005-06-29

3 Chemical and Physical Properties

Molecular Formula	C₁₀H₂₁NO₄
Molecular Weight	219.28 g/mol
XLogP3	-0.6
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	4
Exact Mass	219.14705815 g/mol
Monoisotopic Mass	219.14705815 g/mol
Topological Polar Surface Area	84.2 Å²
Heavy Atom Count	15
Formal Charge	0
Complexity	190
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	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Zavesca
PubMed Health	Miglustat (By mouth)
Drug Classes	Endocrine-Metabolic Agent
Drug Label	Zavesca (miglustat capsules, 100 mg) is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Zavesca is an N-alkylated imino sugar, a...
Active Ingredient	Miglustat
Dosage Form	Capsule
Route	Oral
Strength	100mg
Market Status	Prescription
Company	Actelion Pharms

2 of 2
Drug Name	Zavesca
PubMed Health	Miglustat (By mouth)
Drug Classes	Endocrine-Metabolic Agent
Drug Label	Zavesca (miglustat capsules, 100 mg) is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids. Zavesca is an N-alkylated imino sugar, a...
Active Ingredient	Miglustat
Dosage Form	Capsule
Route	Oral
Strength	100mg
Market Status	Prescription
Company	Actelion Pharms

4.2 Drug Indication

For the treatment of adult patients with mild to moderate type 1 (nonneuropathic) Gaucher's disease for whom enzyme replacement therapy is not a therapeutic option (e.g. due to constraints such as allergy, hypersensitivity, or poor venous access). Now approved in some countries for the treatment of progressive neurological symptoms in adult and pediatric patients with Niemann-Pick disease type C (NP-C).

FDA Label

Miglustat Gen. Orph is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.

Miglustat Gen. Orph may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.

Miglustat Gen. Orph is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

Yargesa is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.

Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.

Yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

Zavesca is indicated for the oral treatment of adult patients with mild to moderate type-1 Gaucher disease. Zavesca may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.

Zavesca is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type-C disease.

Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease.

Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable.

Miglustat Dipharma is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Miglustat, an N-alkylated imino sugar, is a synthetic analogue of D-glucose. Miglustat is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for catalyzing the formation of glucosylceramide (glucocerebroside). Glucosylceramide is a substrate for the endogenous glucocerebrosidase, an enzyme that is deficient in Gaucher's disease. The accumulation of glucosylceramide due to the absence of glucocerebrosidase results in the storage of this material in the lysosomes of tissue macrophages, leading to widespread pathology due to infiltration of lipid-engorged macrophages in the viscera, lymph nodes, and bone marrow. This results in secondary hematologic consequences including sever anemia and thrombocytopenia, in addition to the characteristic progressive hepatosplenomegaly, as well as skeletal complications including osteonecrosis and osteopenia with secondary pathological fractures.

5.2 MeSH Pharmacological Classification

Anti-HIV Agents

Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS. (See all compounds classified as Anti-HIV Agents.)

Glycoside Hydrolase Inhibitors

Compounds that inhibit or block the activity of GLYCOSIDE HYDROLASES such as ALPHA-AMYLASES and ALPHA-GLUCOSIDASES. (See all compounds classified as Glycoside Hydrolase Inhibitors.)

Enzyme Inhibitors

Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

MIGLUSTAT

5.3.2 FDA UNII

ADN3S497AZ

5.3.3 Pharmacological Classes

Glucosylceramide Synthase Inhibitors [MoA]; Glucosylceramide Synthase Inhibitor [EPC]

5.4 ATC Code

A16AX06

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

A16 - Other alimentary tract and metabolism products

A16A - Other alimentary tract and metabolism products

A16AX - Various alimentary tract and metabolism products

A16AX06 - Miglustat

5.5 Absorption, Distribution and Excretion

Absorption

Mean oral bioavailability is 97%.

5.6 Metabolism/Metabolites

There is no evidence that miglustat is metabolized in humans.

5.7 Biological Half-Life

The effective half-life of miglustat is approximately 6 to 7 hours.

5.8 Mechanism of Action

Miglustat functions as a competitive and reversible inhibitor of the enzyme glucosylceramide synthase, the initial enzyme in a series of reactions which results in the synthesis of most glycosphingolipids. The goal of treatment with miglustat is to reduce the rate of glycosphingolipid biosynthesis so that the amount of glycosphingolipid substrate is reduced to a level which allows the residual activity of the deficient glucocerebrosidase enzyme to be more effective (substrate reduction therapy), reducing the accumulation of glucocerebroside in macrophages. In vitro and in vivo studies have shown that miglustat can reduce the synthesis of glucosylceramide-based glycosphingolipids. In clinical trials, miglustat improved liver and spleen volume, as well as hemoglobin concentration and platelet count. Inhibition of glycosphingolipid synthesis has also shown to reduce intracellular lipid storage, improve fluid-phase endosomal uptake and normalize lipid transport in peripheral blood B lymphocytes of NP-C patients, which results in a decrease in the potentially neurotoxic accumulation of gnagliosides G_M2 and G_M3, lactosylceramide and glucosylceramide, possibly preventing further neuronal damage. Other studies have also suggested that miglustat may indirectly modulate intracellular calcium homeostasis through its effects on glucosylceramide levels, and evidence has shown that an initiating factor in the pathogenesis of NP-C may be impaired calcium homeostasis related to sphingosine storage. Therefore, the effect that miglustat exerts on intracellular calcium levels may influence an important underlying pathogenic mechanism of NP-C.

API SUPPLIERS

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USDMF

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JDMF

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EU WC

01

Apicore LLC

India

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Not Confirmed

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NDC API

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Listed Suppliers

01

Veranova

U.S.A

Antibody Engineering

Not Confirmed

Veranova: A CDMO that manages complexity with confidence.

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U.S.A

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Miglustat

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.

02

Cohance Lifesciences

India

Antibody Engineering

Not Confirmed

Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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India

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Miglustat

About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.

03

Laurus Labs

India

Antibody Engineering

Not Confirmed

04

Shanvr Life Sciences

India

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Not Confirmed

05

Viatris

U.S.A

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Not Confirmed

06

Zhejiang Ausun Pharmaceutical

China

Antibody Engineering

Not Confirmed

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API Reference Price

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PHARBIL","customerCountry":"GERMANY","quantity":"0.77","actualQuantity":"0.77","unit":"KGS","unitRateFc":"50000","totalValueFC":"37960.8","currency":"USD","unitRateINR":4131383.1168831168,"date":"24-Sep-2024","totalValueINR":"3181165","totalValueInUsd":"37960.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4283418","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"N\/A, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727116200,"product":"MIGLUSTAT","address":"N\/A","city":"N\/A","supplier":"TIANISH LABORATORIES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ALLPHAMED PHARBIL","customerCountry":"GERMANY","quantity":"12.40","actualQuantity":"12.4","unit":"KGS","unitRateFc":"50000","totalValueFC":"613119.8","currency":"USD","unitRateINR":4143563.5483870967,"date":"24-Sep-2024","totalValueINR":"51380188","totalValueInUsd":"613119.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4283088","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"N\/A, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"MIGLUSTAT","address":"N\/A","city":"N\/A","supplier":"TIANISH LABORATORIES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ALLPHAMED PHARBIL","customerCountry":"GERMANY","quantity":"12.40","actualQuantity":"12.4","unit":"KGS","unitRateFc":"50000","totalValueFC":"613119.8","currency":"USD","unitRateINR":4143563.5483870967,"date":"25-Sep-2024","totalValueINR":"51380188","totalValueInUsd":"613119.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4333239","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"N\/A, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"MIGLUSTAT","address":"N\/A","city":"N\/A","supplier":"TIANISH LABORATORIES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ALLPHAMED PHARBIL","customerCountry":"GERMANY","quantity":"12.40","actualQuantity":"12.4","unit":"KGS","unitRateFc":"50000","totalValueFC":"613119.8","currency":"USD","unitRateINR":4143563.5483870967,"date":"25-Sep-2024","totalValueINR":"51380188","totalValueInUsd":"613119.8","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4336662","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"N\/A, N\/A","customerAddress":""}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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Europe

01

ALFRED E TIEFENBACHER GmbH & Co KG

Germany

Medlab Asia & Asia Health

Not Confirmed

We are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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Germany

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Regulatory Info : Registered in EU

Registration Country : Germany

Miglustat

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Dosage Form : Hard Capsule

Dosage Strength : 100MG

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Regulatory Info : Registered in EU

Registration Country : Germany

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02

ACCORD HEALTHCARE SLU

United Kingdom

Medlab Asia & Asia Health

Not Confirmed

03

Actelion Registration Ltd.

Switzerland

Medlab Asia & Asia Health

Not Confirmed

04

ACTELION REGISTRATION LTD

Medlab Asia & Asia Health

Not Confirmed

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Canada

01

JANSSEN INC

U.S.A

Medlab Asia & Asia Health

Not Confirmed

Virtual Booth

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Regulatory Info : Registered in EU

Registration Country : Germany

Miglustat

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

02

Dipharma Francis S.r.l

Italy

Medlab Asia & Asia Health

Not Confirmed

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Co-Processed Excipients

Direct Compression

Coloring Agents

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Granulation

Emulsifying Agents

Taste Masking

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Patents & EXCLUSIVITIES

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ABOUT THIS PAGE

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

3 USDMF

1 JDMF

1 EU WC

5 NDC API

6 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

23 FDF Dossiers

5 FDA Orange Book

13 Europe

2 Canada

1 South Africa

2 Listed Dossiers

RELATED EXCIPIENT COMPANIES

7 DKSH

1 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

3 Gangwal Healthcare

4 ACG Worldwide

2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 DFE Pharma

1 Gangwal Chemicals

1 Ingredion Pharma Solutions

3 Lonza Capsugel

5 Microlex e.U

1 Pharmatrans-Sanaq

1 Pluviaendo

2 Prachin Chemical

1 Qualicaps

4 Roquette

1 Seppic

2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Sigachi Industries

1 Ulanqab Kema New Material

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

13 Fillers, Diluents & Binders

10 Lubricants & Glidants

9 Disintegrants & Superdisintegrants

8 Empty Capsules

7 Thickeners and Stabilizers

6 Coating Systems & Additives

4 Co-Processed Excipients

3 Direct Compression

3 Coloring Agents

2 Film Formers & Plasticizers

1 Granulation

1 Emulsifying Agents

1 Taste Masking

1 API Stability Enhancers

1 Solubilizers

1 Controlled & Modified Release

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow

22 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

10 Finished Drug Prices

1 Annual Reports

MARKET PLACE

7 APIs

4 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 US Patents

1 US Exclusivities

1 Health Canada Patents

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)