Synopsis
Synopsis
0
VMF
0
FDA Orange Book
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
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
API SUPPLIERS
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Certificate Number : CEP 2021-095 - Rev 00
Issue Date : 2024-07-10
Type : Chemical
Substance Number : 2888
Status : Valid
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : CEP 2023-016 - Rev 00
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2888
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38451
Submission : 2023-05-31
Status : Active
Type : II
Certificate Number : CEP 2018-180 - Rev 03
Issue Date : 2025-04-01
Type : Chemical
Substance Number : 2888
Status : Valid
Date of Issue : 2022-06-15
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183
Address of the Firm :
NDC Package Code : 66577-035
Start Marketing Date : 2018-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2020-09-04
Registration Number : Su30-4-ND
Manufacturer Name : Vasudha Pharma Chem Limited@ [Manufacturer of Desloratadine] Vasudha Pharma Chem Limited
Manufacturer Address : Unit-Ⅱ, Plot No. 79, Jawaharlal Nehru Pharma City, Thanam(V), Parawada(M), Anakapalli - 531019, Andhra Pradesh, India@ [Manufacturer of Desloratadine] Unit-I, Plot No. 37/A, 38, 39 A & B, Phase-I, IDA., Jeedimetla, Hyderabad – 500 055, Telangana, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36047
Submission : 2021-08-09
Status : Active
Type : II
Certificate Number : R1-CEP 2017-202 - Rev 00
Issue Date : 2023-08-09
Type : Chemical
Substance Number : 2888
Status : Valid
Registration Number : 228MF10183
Registrant's Address : Poli(´)gon Industrial Riera de Caldes Avinguda Cami(´) Reial 51-57 08184 Palau-Solita(´) i Pleamans Barcelona SPAIN
Initial Date of Registration : 2016-09-09
Latest Date of Registration :
Registrant Name : Ankuk Pharmaceutical Co., Ltd.
Registration Date : 2017-01-09
Registration Number : Su4532-1-ND
Manufacturer Name : Urquima SA
Manufacturer Address : Arnau de Vilanova 22-42 08105 Sant Fost de Campsentelles (Barcelona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26210
Submission : 2012-09-27
Status : Inactive
Type : II
Registration Number : 306MF10071
Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA
Initial Date of Registration : 2024-05-29
Latest Date of Registration :
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074Amended
Address of the Firm :
Certificate Number : R0-CEP 2018-213 - Rev 01
Issue Date : 2022-10-26
Type : Chemical
Substance Number : 2888
Status : Valid
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0231n
Address of the Firm :
Certificate Number : CEP 2024-018 - Rev 00
Issue Date : 2024-11-06
Type : Chemical
Substance Number : 2888
Status : Valid
Date of Issue : 2022-06-18
Valid Till : 2025-07-07
Written Confirmation Number : WC-0055n
Address of the Firm :
Registrant Name : Klasia Co., Ltd.
Registration Date : 2021-07-23
Registration Number : No. 173-28-ND(1)
Manufacturer Name : FDC Limited
Manufacturer Address : Plot No. 19 & 20/2, MIDC, Roha Industrial Area, Village Dhatav, Roha, Raigad 402 116, Maharashtra State, India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
69
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 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.
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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Rupatadine 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 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.
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 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.
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).
