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Also known as: 182349-12-8, Rupatadin fumarate, Rupafin, Ur-12592 fumarate, Rupatadine (fumarate), Alergoliber
Molecular Formula
C30H30ClN3O4
Molecular Weight
532.0  g/mol
InChI Key
JYBLCDXVHQWMSU-WLHGVMLRSA-N
FDA UNII
XJ6OT32M93

Rupatadine Fumarate
1 2D Structure

Rupatadine Fumarate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-but-2-enedioic acid;13-chloro-2-[1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene]-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene
2.1.2 InChI
InChI=1S/C26H26ClN3.C4H4O4/c1-18-13-19(16-28-15-18)17-30-11-8-20(9-12-30)25-24-7-6-23(27)14-22(24)5-4-21-3-2-10-29-26(21)25;5-3(6)1-2-4(7)8/h2-3,6-7,10,13-16H,4-5,8-9,11-12,17H2,1H3;1-2H,(H,5,6)(H,7,8)/b;2-1+
2.1.3 InChI Key
JYBLCDXVHQWMSU-WLHGVMLRSA-N
2.1.4 Canonical SMILES
CC1=CC(=CN=C1)CN2CCC(=C3C4=C(CCC5=C3N=CC=C5)C=C(C=C4)Cl)CC2.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CC1=CC(=CN=C1)CN2CCC(=C3C4=C(CCC5=C3N=CC=C5)C=C(C=C4)Cl)CC2.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
XJ6OT32M93
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 182349-12-8

2. Rupatadin Fumarate

3. Rupafin

4. Ur-12592 Fumarate

5. Rupatadine (fumarate)

6. Alergoliber

7. Rinialer

8. Xj6ot32m93

9. 182349-12-8 (fumarate)

10. Rupax

11. 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5h-benzo[5,6]cyclohepta[1,2-b]pyridine Fumarate

12. Rupatadine Fumarate (jan)

13. 1217234-48-4

14. Rupatadine Fumarate [jan]

15. (2e)-but-2-enedioic Acid; 13-chloro-2-{1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene}-4-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(15),3,5,7,11,13-hexaene

16. 5h-benzo[5,6]cyclohepta[1,2-b]pyridine, 8-chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridinyl)methyl]-4-piperidinylidene]-, (2e)-2-butenedioate (1:1)

17. Mfcd00926499

18. Unii-xj6ot32m93

19. Rupatall

20. Tamalis

21. Wystamm

22. Ralif

23. Rinialer (tn)

24. 5h-benzo(5,6)cyclohepta(1,2-b)pyridine, 8-chloro-6,11-dihydro-11-(1-((5-methyl-3-pyridinyl)methyl)-4-piperidinylidene)-, (2e)-2-butenedioate (1:1)

25. Rupafin (tn)

26. Rupatadine Fumarate- Bio-x

27. 5h-benzo(5,6)cyclohepta(1,2-b)pyridine, 6,11-dihydro-8-chloro-11-(1-((5-methyl-3-pyridinyl)methyl)-4-piperidinylidene)-, (e)-2-butenedioate (1:1)

28. 8-chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridyl)methyl]-4-piperidylidene]-5h-benzo[5,6]cyclohepta[1,2-b]pyridine Fumarate

29. Mls006010150

30. Schembl180121

31. Schembl180512

32. Rupatadine Fumarate [mi]

33. Hms3885k05

34. Bcp05230

35. Hy-13511a

36. Rupatadine Fumarate [who-dd]

37. S3052

38. Akos005145898

39. Ac-9016

40. Ccg-269922

41. Cs-3482

42. F76r825

43. Ks-1229

44. Br164385

45. Rupatadine Fumarate [ep Monograph]

46. Smr004701267

47. Sw219889-1

48. C73520

49. D08497

50. Q-201688

51. Q27293863

52. (e)-but-2-enedioic Acid;13-chloro-2-[1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene]-4-azatricyclo[9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaene

2.4 Create Date
2006-04-29
3 Chemical and Physical Properties
Molecular Weight 532.0 g/mol
Molecular Formula C30H30ClN3O4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count4
Exact Mass531.1924841 g/mol
Monoisotopic Mass531.1924841 g/mol
Topological Polar Surface Area104 Ų
Heavy Atom Count38
Formal Charge0
Complexity728
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Treatment of allergic rhinitis, Treatment of chronic idiopathic urticaria


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07-Jan-2022
30-Jun-2025
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Looking for 182349-12-8 / Rupatadine Fumarate API manufacturers, exporters & distributors?

Rupatadine Fumarate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Rupatadine Fumarate 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 Rupatadine Fumarate manufacturer or Rupatadine Fumarate supplier for your needs.

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

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

API | Excipient name

Rupatadine Fumarate

Synonyms

182349-12-8, Rupatadin fumarate, Rupafin, Ur-12592 fumarate, Rupatadine (fumarate), Alergoliber

Cas Number

182349-12-8

Unique Ingredient Identifier (UNII)

XJ6OT32M93

Rupatadine Manufacturers

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

Rupatadine Suppliers

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

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

Rupatadine USDMF

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

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

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

Rupatadine 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 Rupatadine Drug Master File in Japan (Rupatadine JDMF) empowers Rupatadine 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 Rupatadine JDMF during the approval evaluation for pharmaceutical products. At the time of Rupatadine 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 Rupatadine suppliers with JDMF on PharmaCompass.

Rupatadine KDMF

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

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

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

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

Rupatadine CEP

A Rupatadine CEP of the European Pharmacopoeia monograph is often referred to as a Rupatadine Certificate of Suitability (COS). The purpose of a Rupatadine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rupatadine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rupatadine to their clients by showing that a Rupatadine CEP has been issued for it. The manufacturer submits a Rupatadine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rupatadine CEP holder for the record. Additionally, the data presented in the Rupatadine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rupatadine DMF.

A Rupatadine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rupatadine 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 Rupatadine suppliers with CEP (COS) on PharmaCompass.

Rupatadine WC

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

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

Rupatadine 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 Rupatadine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Rupatadine GMP

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

Rupatadine CoA

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

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

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