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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
| Molecular Weight | 532.0 g/mol |
|---|---|
| Molecular Formula | C30H30ClN3O4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 4 |
| Exact Mass | 531.1924841 g/mol |
| Monoisotopic Mass | 531.1924841 g/mol |
| Topological Polar Surface Area | 104 Ų |
| Heavy Atom Count | 38 |
| Formal Charge | 0 |
| Complexity | 728 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Treatment of allergic rhinitis, Treatment of chronic idiopathic urticaria
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Drugs in Development
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Regulatory Info :
Registration Country : Italy
Brand Name : RUPATADINA AUROBINDO
Dosage Form : Tablets
Dosage Strength : 10 mg
Packaging : 30 UNITS 10 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Rupatadina Kern Pharma
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2015-11-27
Application Number : 80440
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Rupatadina Gobens
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2018-07-13
Application Number : 83303
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Rinialer
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2023-04-25
Application Number : 3400938416220
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info :
Registration Country : Italy
Brand Name : MOSTAXYL
Dosage Form : Tablets
Dosage Strength : 10 mg
Packaging : 30 UNITS 10 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Rupatadina Stada
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2016-05-18
Application Number : 80832
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Rescetin
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2017-09-11
Application Number : 82384
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Cancelled
Registration Country : Spain
Brand Name : Rupatadina Trombicor
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2016-12-20
Application Number : 81543
Regulatory Info : Cancelled
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Alergoliber
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2003-04-23
Application Number : 65350
Regulatory Info : Authorized
Registration Country : Spain
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Regulatory Info : Prescription
Registration Country : Canada
RUPATADINE (RUPATADINE FUMARATE)
Brand Name : APO-RUPATADINE
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2553155
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
RUPATADINE (RUPATADINE FUMARATE)
Brand Name : RUPALL
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2456451
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
RUPATADINE (RUPATADINE FUMARATE)
Brand Name : RUPALL
Dosage Form : SOLUTION
Dosage Strength : 1MG/ML
Packaging :
Approval Date :
Application Number : 2456478
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
RUPATADINE (RUPATADINE FUMARATE)
Brand Name : PMS-RUPATADINE
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2552604
Regulatory Info : Prescription
Registration Country : Canada
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rualidine 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rualidine 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
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Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rutarn 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rutarn 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
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Regulatory Info : Generic
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rupallerg10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Rupanase 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 20X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Rupanase 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Zealargy
Dosage Form : Tab
Dosage Strength : 10mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Zealargy
Dosage Form : Tab
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : RAZTROL
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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Dosage Form : Tablet
Dosage Strength : 10mg
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Dosage : Tablet
Dosage Strength : 10mg
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Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
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Brand Name : Alarup
Dosage Form : Tablet
Dosage Strength : 10MG
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Regulatory Info :
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Dosage : Tablet
Dosage Strength : 10MG
Brand Name : Alarup
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Brand Name :
Dosage Form : Tablet
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Dosage : Tablet
Dosage Strength : 10MG
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Registration Country : France
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging : 10mgx3tabs; 10mgx5tabs; 10mgx10tabs
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging : 10mgx3tabs; 10mgx5tabs; 10mgx10tabs
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name :
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Registration Country : China
Regulatory Info :
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Brand Name :
Dosage Form : DC Granules and Tablet...
Dosage Strength : 10MG
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Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : DC Granules and Tablet...
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
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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.
A Rupatall manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rupatall, including repackagers and relabelers. The FDA regulates Rupatall manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rupatall 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 Rupatall manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rupatall supplier is an individual or a company that provides Rupatall active pharmaceutical ingredient (API) or Rupatall finished formulations upon request. The Rupatall suppliers may include Rupatall API manufacturers, exporters, distributors and traders.
click here to find a list of Rupatall suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rupatall DMF (Drug Master File) is a document detailing the whole manufacturing process of Rupatall active pharmaceutical ingredient (API) in detail. Different forms of Rupatall DMFs exist exist since differing nations have different regulations, such as Rupatall USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rupatall DMF submitted to regulatory agencies in the US is known as a USDMF. Rupatall USDMF includes data on Rupatall's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rupatall USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rupatall suppliers with USDMF on PharmaCompass.
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 Rupatall Drug Master File in Japan (Rupatall JDMF) empowers Rupatall 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 Rupatall JDMF during the approval evaluation for pharmaceutical products. At the time of Rupatall 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 Rupatall suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Rupatall Drug Master File in Korea (Rupatall KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rupatall. The MFDS reviews the Rupatall KDMF as part of the drug registration process and uses the information provided in the Rupatall KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rupatall 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 Rupatall API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rupatall suppliers with KDMF on PharmaCompass.
A Rupatall CEP of the European Pharmacopoeia monograph is often referred to as a Rupatall Certificate of Suitability (COS). The purpose of a Rupatall CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rupatall EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rupatall to their clients by showing that a Rupatall CEP has been issued for it. The manufacturer submits a Rupatall CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rupatall CEP holder for the record. Additionally, the data presented in the Rupatall CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rupatall DMF.
A Rupatall CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rupatall 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 Rupatall suppliers with CEP (COS) on PharmaCompass.
A Rupatall written confirmation (Rupatall WC) is an official document issued by a regulatory agency to a Rupatall manufacturer, verifying that the manufacturing facility of a Rupatall active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rupatall APIs or Rupatall finished pharmaceutical products to another nation, regulatory agencies frequently require a Rupatall WC (written confirmation) as part of the regulatory process.
click here to find a list of Rupatall suppliers with Written Confirmation (WC) 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 Rupatall as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rupatall 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 Rupatall 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 Rupatall and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rupatall NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rupatall suppliers with NDC on PharmaCompass.
Rupatall 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 Rupatall 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 Rupatall GMP manufacturer or Rupatall GMP API supplier for your needs.
A Rupatall CoA (Certificate of Analysis) is a formal document that attests to Rupatall's compliance with Rupatall specifications and serves as a tool for batch-level quality control.
Rupatall CoA mostly includes findings from lab analyses of a specific batch. For each Rupatall 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.
Rupatall may be tested according to a variety of international standards, such as European Pharmacopoeia (Rupatall EP), Rupatall JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rupatall USP).
