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Chemistry

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Also known as: Urapidil hcl, 64887-14-5, Urapidil (hydrochloride), Pvu92pzo12, Ncgc00094502-01, Ebrantil (tn)
Molecular Formula
C20H30ClN5O3
Molecular Weight
423.9  g/mol
InChI Key
KTMLZVUAXJERAT-UHFFFAOYSA-N
FDA UNII
PVU92PZO12

Urapidil Hydrochloride
1 2D Structure

Urapidil Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
6-[3-[4-(2-methoxyphenyl)piperazin-1-yl]propylamino]-1,3-dimethylpyrimidine-2,4-dione;hydrochloride
2.1.2 InChI
InChI=1S/C20H29N5O3.ClH/c1-22-18(15-19(26)23(2)20(22)27)21-9-6-10-24-11-13-25(14-12-24)16-7-4-5-8-17(16)28-3;/h4-5,7-8,15,21H,6,9-14H2,1-3H3;1H
2.1.3 InChI Key
KTMLZVUAXJERAT-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1C(=CC(=O)N(C1=O)C)NCCCN2CCN(CC2)C3=CC=CC=C3OC.Cl
2.2 Other Identifiers
2.2.1 UNII
PVU92PZO12
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Urapidil Hcl

2. 64887-14-5

3. Urapidil (hydrochloride)

4. Pvu92pzo12

5. Ncgc00094502-01

6. Ebrantil (tn)

7. Dsstox_cid_25812

8. Dsstox_rid_81149

9. Dsstox_gsid_45812

10. 6-[3-[4-(2-methoxyphenyl)piperazin-1-yl]propylamino]-1,3-dimethylpyrimidine-2,4-dione;hydrochloride

11. 6-((3-(4-(2-methoxyphenyl)piperazin-1-yl)propyl)amino)-1,3-dimethylpyrimidine-2,4(1h,3h)-dione Hydrochloride

12. 6-[[3-[4-(2-methoxyphenyl)-1-piperazinyl]propyl]amino]-1,3-dimethyl-2,4(1h,3h)-pyrimidinedione Monohydrochloride

13. Smr000058525

14. Sr-01000075295

15. Cas-64887-14-5

16. Unii-pvu92pzo12

17. Urapidilhydrochloride

18. Urapidil Hydrochloride,(s)

19. Urapidil Hydrochloride, Solid

20. Mls000758309

21. Mls001424033

22. C20h29n5o3.hcl

23. Schembl1321654

24. Chembl1256716

25. Dtxsid2045812

26. Hy-b0354a

27. Hms1570f12

28. Pharmakon1600-01503100

29. Bcp23389

30. Tox21_111286

31. Tox21_501265

32. Mfcd00078601

33. Nsc758226

34. S2025

35. Akos015994621

36. Tox21_111286_1

37. Ac-8089

38. Ccg-100798

39. H61u751

40. Hs-0064

41. Lp01265

42. Nc00048

43. Nsc-758226

44. Urapidil Hydrochloride [who-dd]

45. Ncgc00016066-14

46. Ncgc00261950-01

47. Eu-0101265

48. Ft-0675734

49. Sw197244-4

50. U-100

51. C76033

52. D08662

53. Sr-01000075295-1

54. Sr-01000075295-3

55. Sr-01000075295-9

56. Q27286781

57. Sr-01000075295-10

58. 6[[3-[4-(o-methoxyphenyl)-1-piperazinyl]propyl]amino]-1,3-dimethyluracil Hydrochloride

59. 2,4(1h,3h)-pyrimidinedione, 6-((3-(4-(2-methoxyphenyl)-1-piperazinyl)propyl)amino)-1,3-dimethyl-, Monohydrochloride

60. 6-(3-(4-(2-methoxyphenyl)piperazin-1-yl)propylamino)-1,3-dimethylpyrimidine-2,4(1h,3h)-dione Hydrochloride

61. 6-[[3-[4-(2-methoxyphenyl)-1-pipera Zinyl]propyl]amino]-1,3-dimethyl-2,4(1h,3h)-pyrimi Dinedione Hydrochloride

62. 6-[[3-[4-(2-methoxyphenyl)-1-piperazinyl]propyl]amino]-1,3-dimethyl-2,4(1h,3h)-pyrimidinedione Hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 423.9 g/mol
Molecular Formula C20H30ClN5O3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count7
Exact Mass423.2037175 g/mol
Monoisotopic Mass423.2037175 g/mol
Topological Polar Surface Area68.4 Ų
Heavy Atom Count29
Formal Charge0
Complexity588
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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01

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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USDMF CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
Biophore

02

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
Biophore

03

Hangzhou APIChem Technology

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

EPS
Not Confirmed
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Hangzhou APIChem Technology

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Country

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05

Erregierre SpA

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

EPS
Not Confirmed
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Erregierre SpA

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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06

Olon S.p.A

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

EPS
Not Confirmed
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Olon S.p.A

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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07

Mangalmurti Bio-chem

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

EPS
Not Confirmed
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08

Hebei AiYoung Pharmaceutical Techn...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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09

Zydus Takeda Healthcare

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Zydus Takeda Healthcare

India

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10

Zydus Takeda Healthcare

India

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Zydus Takeda Healthcare

India

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EU WC

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01

  • fda
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  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Urapidil Hydrochloride IH

Date of Issue : 2025-02-27

Valid Till : 2028-02-26

Written Confirmation Number : WC-511n

Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...

Biophore

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Urapidil Hydrochloride IH

Date of Issue : 2025-02-27

Valid Till : 2028-02-26

Written Confirmation Number : WC-0511

Address of the Firm : Plot No. 80A, Road No.5, Jawaharlal Nehru Pharma City, E. Bonangi (V), Parawada ...

Biophore

03

Pharmex
Not Confirmed
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Pharmex
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Urapidil Hydrochloride IH

Date of Issue : 2022-06-15

Valid Till : 2025-07-07

Written Confirmation Number : WC-0204

Address of the Firm : C-4, MIDC, Village Pawne, Thane Belapur Road, Vashi, Navi Mumbai ? 400 703

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04

Pharmex
Not Confirmed
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Pharmex
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Urapidil IH

Date of Issue : 2022-06-15

Valid Till : 2025-07-07

Written Confirmation Number : WC-0204

Address of the Firm : C-4, MIDC, Village Pawne, Thane Belapur Road, Vashi, Navi Mumbai ? 400 703

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Flag India
Digital Content Digital Content

Urapidil Hydrochloride

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
Biophore

02

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Urapidil Hydrochloride

About the Company : Beijing Fukangren Biopharmaceutical Technology Co., Ltd. started its drug R&D service in 1999 and is the CRO company with the longest continuous service time in China. Fukangren no...

Beijing Fukangren Biopharmaceutical Technology Co., Ltd. started its drug R&D service in 1999 and is the CRO company with the longest continuous service time in China. Fukangren now has 3 pharmaceutical R&D centers, 1 clinical R&D center, 4 API production bases and 1 preparation production base, forming an end-to-end CDMO service system that can provide customers with drug R&D and production. The development of high-end formulations is a major advantage of Fukangren. Among them, multiple platform projects such as sustained and controlled release formulations.
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03

EPS
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Urapidil Hydrochloride

About the Company : ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIE...

ERREGIERRE, a family company, was founded in 1974 and today is one of the leading Italian active pharmaceutical ingredients manufactures for human and veterinary use. In ERREGIERRE we employ more than 220 people and two manufacturing sites, San Paolo d’Argon and Sovere, are both FDA inspected with no 483 form. We provide APIs of the highest quality and we are a reliable partner for the pharmaceutical industry worldwide.
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Urapidil Hydrochloride

About the Company : Hebei AiYoung Pharmaceutical Technology Co., Ltd. is a professional company mainly engaged in chemical APIs and intermediates, including R & D, production, import and export. The c...

Hebei AiYoung Pharmaceutical Technology Co., Ltd. is a professional company mainly engaged in chemical APIs and intermediates, including R & D, production, import and export. The company is committed to building a professional API and intermediate supply platform to provide high-quality intermediate, API and related preparation technologies and other high-quality product services for domestic and foreign pharmaceutical enterprises.
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Urapidil Hydrochloride

About the Company : Hiray Pharma Solutions is an international end-to-end CDMO, facilitating the development and manufacturing of important drug products and key intermediates around the world. We pro...

Hiray Pharma Solutions is an international end-to-end CDMO, facilitating the development and manufacturing of important drug products and key intermediates around the world. We provide the best chemical techniques, control, and manufacturing services to pharmaceutical and innovative enterprises, and a swift path for fine medicine to benefit patients. As an end-to-end CDMO, Hiray can provide on-time, high-quality service for Process R&D, Analytical R&D, Manufacturing, and Quality Control. Hiray operates in strict compliance with, or exceeds, the latest standards for safety, health, and the environment.
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EPS
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Urapidil Hydrochloride

About the Company : Mangalmurti Bio-Chem Private Limited was established in 2010, initially focusing on the production of NPK fertilizer blends with a daily capacity of 200 tons. The company successfu...

Mangalmurti Bio-Chem Private Limited was established in 2010, initially focusing on the production of NPK fertilizer blends with a daily capacity of 200 tons. The company successfully supplied its products across Gujarat, Maharashtra, Rajasthan, and Madhya Pradesh. However, in recent years, market conditions have declined, and stricter government regulations have restricted access to key raw materials. With a strong focus on innovation and sustainability, the company embarked on this new path in 2015, aiming to develop high-quality organic and inorganic chemical compounds.
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07

Olon S.p.A

Italy
EPS
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Olon S.p.A

Italy
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Urapidil Hydrochloride

About the Company : We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (...

We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for generic and contract development and the manufacturing market, in a full cGMPs environment, following ICH Q7 compliance.
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Urapidil Hydrochloride

About the Company : Established in 1999, Hankang Pharmaceutical Group stands as a prominent CRO-CDMO integrated service enterprise in China. Focused on generic drugs while venturing into innovative on...

Established in 1999, Hankang Pharmaceutical Group stands as a prominent CRO-CDMO integrated service enterprise in China. Focused on generic drugs while venturing into innovative ones, the group is dedicated to offering comprehensive solutions to the industry. Presently, Hankang has crafted over 200 varieties for 600+ domestic and international companies, serving 10+ innovative drugs. It has successfully developed more than 10 initial generic drugs, with over 20 varieties endorsed by the top three domestic companies and 30 exceeding a 100 million output value.
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API Reference Price

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01-Jan-2022
28-May-2025
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Drugs in Development

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Details:

The portfolio to be divested to Hasten includes cardiovascular and metabolism products sold in mainland China which includes Ebrantil®.


Lead Product(s): Urapidil Hydrochloride

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Ebrantil

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Hasten Biopharmaceutic

Deal Size: $322.0 million Upfront Cash: Undisclosed

Deal Type: Divestment December 21, 2020

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Details : The portfolio to be divested to Hasten includes cardiovascular and metabolism products sold in mainland China which includes Ebrantil®.

Product Name : Ebrantil

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

December 21, 2020

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INTERMEDIATE SUPPLIERS

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CAS Number : 35386-24-4

End Use API : Urapidil Hydrochloride

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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CAS Number : 5464-78-8

End Use API : Urapidil Hydrochloride

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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CAS Number : 6972-27-6

End Use API : Urapidil Hydrochloride

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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CAS Number : 5464-78-8

End Use API : Urapidil Hydrochloride

About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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Bakul Group

India
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Bakul Group

India
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CAS Number : 6642-31-5

End Use API : Urapidil Hydrochloride

About The Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (AP...

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Bakul Group

India
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Bakul Group

India
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CAS Number : 6972-27-6

End Use API : Urapidil Hydrochloride

About The Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (AP...

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Bakul Group

India
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Bakul Group

India
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CAS Number : 34654-81-4

End Use API : Urapidil Hydrochloride

About The Company : The Bakul Group of companies headquartered in Mumbai, India are engaged in the development and manufacture of high-quality Active Pharmaceutical Ingredients (AP...

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CAS Number : 5464-78-8

End Use API : Urapidil Hydrochloride

About The Company : Integrin Life Sciences Pvt. Ltd. is one of the growing pharmaceutical API, advanced chemical intermediates manufacturing companies in India. Our Plant is Locate...

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CAS Number : 34654-81-4

End Use API : Urapidil Hydrochloride

About The Company : Integrin Life Sciences Pvt. Ltd. is one of the growing pharmaceutical API, advanced chemical intermediates manufacturing companies in India. Our Plant is Locate...

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CAS Number : 6972-27-6

End Use API : Urapidil Hydrochloride

About The Company : The division was established in 1981 as a Specialty Chemicals Division with a focus to manufacture specialty chemicals and pharmaceutical intermediates. In Apri...

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Europe

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Urapidil

Brand Name : Urasap

Dosage Form : Urapidil 50Mg 10Ml 5 Units Parenteral Use

Dosage Strength : 5 VIALS EV 10 ml 50 mg/10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Stragen Pharma SA

Switzerland
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Stragen Pharma SA

Switzerland
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Urapidil

Brand Name : Urapidil

Dosage Form : Urapidil 50Mg 10Ml 5 Units Parenteral Use

Dosage Strength : 5 EV vials 50 mg 10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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TAKEDA

Japan
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TAKEDA

Japan
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Urapidil

Brand Name : Ebrantil

Dosage Form : Urapidil 50Mg 10Ml 5 Units Parenteral Use

Dosage Strength : 5 EV vials 50 mg 10 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Listed Dossiers

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Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Flag Austria
Digital Content Digital Content

Regulatory Info :

Registration Country : Austria

Urapidil

Brand Name : Tachyben

Dosage Form : Solution for Injection

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Austria

Ever Pharma CB

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Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Flag Austria
Digital Content Digital Content

Packaging :

Regulatory Info :

Urapidil

Dosage : Solution for Injection

Dosage Strength : 50MG

Brand Name : Tachyben

Approval Date :

Application Number :

Registration Country : Austria

Ever Pharma CB

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Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Flag Austria
Digital Content Digital Content

Regulatory Info :

Registration Country : Austria

Urapidil

Brand Name : Tachyben

Dosage Form : Solution for Injection

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Austria

Ever Pharma CB

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Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Flag Austria
Digital Content Digital Content

Packaging :

Regulatory Info :

Urapidil

Dosage : Solution for Injection

Dosage Strength : 25MG

Brand Name : Tachyben

Approval Date :

Application Number :

Registration Country : Austria

Ever Pharma CB

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Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Flag Austria
Digital Content Digital Content

Regulatory Info :

Registration Country : Austria

Urapidil

Brand Name : Tachyben

Dosage Form : Solution for Injection

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Austria

Ever Pharma CB

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Ever Pharma

Austria
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEver Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.

Flag Austria
Digital Content Digital Content

Packaging :

Regulatory Info :

Urapidil

Dosage : Solution for Injection

Dosage Strength : 100MG

Brand Name : Tachyben

Approval Date :

Application Number :

Registration Country : Austria

Ever Pharma CB

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Farmatek

Turkey
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Farmatek

Turkey
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Urapidil Hydrochloride

Brand Name :

Dosage Form : Solution for Injection

Dosage Strength : 25MG/5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Farmatek

Turkey
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Farmatek

Turkey
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Urapidil Hydrochloride

Dosage : Solution for Injection

Dosage Strength : 25MG/5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Turkey

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Medreich

India
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India
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Urapidil

Brand Name :

Dosage Form : Capsule

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Medreich

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Urapidil

Dosage : Capsule

Dosage Strength : 60MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Stragen Pharma SA

Switzerland
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Stragen Pharma SA

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Urapidil

Brand Name :

Dosage Form : Prolonged Release Caps...

Dosage Strength : 30MG

Packaging : 30, 50, 60 (2x 30),90 (3x 30) and 100 (2x 50) capsules

Approval Date :

Application Number :

Regulatory Info :

Registration Country :

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Stragen Pharma SA

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Urapidil

Dosage : Prolonged Release Caps...

Dosage Strength : 30MG

Brand Name :

Approval Date :

Application Number :

Registration Country :

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Stragen Pharma SA

Switzerland
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Urapidil

Brand Name :

Dosage Form : Prolonged Release Caps...

Dosage Strength : 90MG

Packaging : 30, 50, 60 (2x 30),90 (3x 30) and 100 (2x 50) capsules

Approval Date :

Application Number :

Regulatory Info :

Registration Country :

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Stragen Pharma SA

Switzerland
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Stragen Pharma SA

Switzerland
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Urapidil

Dosage : Prolonged Release Caps...

Dosage Strength : 90MG

Brand Name :

Approval Date :

Application Number :

Registration Country :

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Stragen Pharma SA

Switzerland
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Stragen Pharma SA

Switzerland
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Urapidil

Brand Name :

Dosage Form : Solution for Injection...

Dosage Strength : 5MG/ML

Packaging : 5 ml, 10 ml and 20 ml in glass ampoule; 5 ampoules

Approval Date :

Application Number :

Regulatory Info :

Registration Country :

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Stragen Pharma SA

Switzerland
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Stragen Pharma SA

Switzerland
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Urapidil

Dosage : Solution for Injection...

Dosage Strength : 5MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country :

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Substipharm

France
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Substipharm

France
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Urapidil Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

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Substipharm

France
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Substipharm

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Urapidil Hydrochloride

Dosage : Capsule

Dosage Strength : 30MG

Brand Name :

Approval Date :

Application Number :

Registration Country : France

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Substipharm

France
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Substipharm

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Urapidil Hydrochloride

Brand Name :

Dosage Form : Capsule

Dosage Strength : 60MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

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Substipharm

France
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Substipharm

France
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Urapidil Hydrochloride

Dosage : Capsule

Dosage Strength : 60MG

Brand Name :

Approval Date :

Application Number :

Registration Country : France

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ABOUT THIS PAGE

Looking for 64887-14-5 / Urapidil Hydrochloride API manufacturers, exporters & distributors?

Urapidil Hydrochloride manufacturers, exporters & distributors 1

53

PharmaCompass offers a list of Urapidil Hydrochloride 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 Urapidil Hydrochloride manufacturer or Urapidil Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urapidil Hydrochloride manufacturer or Urapidil Hydrochloride supplier.

PharmaCompass also assists you with knowing the Urapidil Hydrochloride API Price utilized in the formulation of products. Urapidil Hydrochloride API Price is not always fixed or binding as the Urapidil Hydrochloride Price is obtained through a variety of data sources. The Urapidil Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Urapidil Hydrochloride

Synonyms

Urapidil hcl, 64887-14-5, Urapidil (hydrochloride), Pvu92pzo12, Ncgc00094502-01, Ebrantil (tn)

Cas Number

64887-14-5

Unique Ingredient Identifier (UNII)

PVU92PZO12

Uraprene Manufacturers

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

Uraprene Suppliers

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

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

Uraprene USDMF

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

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

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

Uraprene JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Uraprene Drug Master File in Japan (Uraprene JDMF) empowers Uraprene API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Uraprene JDMF during the approval evaluation for pharmaceutical products. At the time of Uraprene JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Uraprene suppliers with JDMF on PharmaCompass.

Uraprene KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Uraprene Drug Master File in Korea (Uraprene KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Uraprene. The MFDS reviews the Uraprene KDMF as part of the drug registration process and uses the information provided in the Uraprene KDMF to evaluate the safety and efficacy of the drug.

After submitting a Uraprene 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 Uraprene API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Uraprene suppliers with KDMF on PharmaCompass.

Uraprene WC

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

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

Uraprene 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 Uraprene as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Uraprene GMP

Uraprene 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 Uraprene 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 Uraprene GMP manufacturer or Uraprene GMP API supplier for your needs.

Uraprene CoA

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

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

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