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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
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26210
Submission : 2012-09-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36047
Submission : 2021-08-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38451
Submission : 2023-05-31
Status : Active
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
Rupatadine Fumarate, Micronised, Non-micronised
Certificate Number : CEP 2021-095 - Rev 00
Status : Valid
Issue Date : 2024-07-10
Type : Chemical
Substance Number : 2888
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : CEP 2023-016 - Rev 00
Status : Valid
Issue Date : 2024-07-09
Type : Chemical
Substance Number : 2888
Certificate Number : CEP 2018-161 - Rev 02
Status : Valid
Issue Date : 2024-01-25
Type : Chemical
Substance Number : 2888
Certificate Number : CEP 2024-018 - Rev 00
Status : Valid
Issue Date : 2024-11-06
Type : Chemical
Substance Number : 2888
Certificate Number : R0-CEP 2018-213 - Rev 01
Status : Valid
Issue Date : 2022-10-26
Type : Chemical
Substance Number : 2888
Certificate Number : R1-CEP 2017-202 - Rev 00
Status : Valid
Issue Date : 2023-08-09
Type : Chemical
Substance Number : 2888
Certificate Number : R0-CEP 2018-180 - Rev 02
Status : Valid
Issue Date : 2023-02-02
Type : Chemical
Substance Number : 2888
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Rupatadine fumarate (for manufacturing purposes only)
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 : 2024-05-29
Registration Number : 228MF10183
Registrant's Address : Poli(´)gon Industrial Riera de Caldes Avinguda Cami(´) Reial 51-57 08184 Palau-Soli...
Initial Date of Registration : 2016-09-09
Latest Date of Registration : 2017-06-30
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Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074
Address of the Firm : 294, GIDC Estate, Ankleshwar-393 002, Bharuch, Gujarat, India
Date of Issue : 2019-07-29
Valid Till : 2022-07-02
Written Confirmation Number : WC-0074A1
Address of the Firm : 294, GIDC Estate, Ankleshwar-393 002, Bharuch, Gujarat, India
Date of Issue : 2022-12-16
Valid Till : 2025-12-15
Written Confirmation Number : WC-0544
Address of the Firm : Plot No. 825,826,827, Industrial Area, Sector-Ill, Pithampur,\\r\\nDhar-454774, ...
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0231
Address of the Firm : D No.6/223 Sarpavaram Kakinada AP
Date of Issue : 2022-06-15
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183nA2
Address of the Firm : Unit -II, Plot No.79,\r\n\r\nJawaharlal Nehru Pharmacity,\r\n\r\nThanam Village,...
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0183
Address of the Firm : Unit-II, Plot No.79, Jawaharlal Nehru Pharma City, Thanam Village, Parawad Manda...
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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
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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
About the Company : Aptra Synthesis Private Limited, is a reliable and vertically integrated manufacturer of APIs and intermediates, boasting state-of-the-art manufacturing facilities that adhere to G...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...
About the Company : Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable ...
About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...
About the Company : FDC continues to uphold the pioneering spirit of its founding vision, achieving accreditations from esteemed regulatory bodies such as the US-FDA, UK-MHRA, MCC-RSA, and UAE authori...
About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...
About the Company : NOUCOR, headquartered near Barcelona, is a forward-thinking chemical-pharmaceutical company with a rich history spanning nearly two centuries. We operate three specialized manufact...
About the Company : Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals...
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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INTERMEDIATES SUPPLIERS
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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Rupallerg10
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 : Rupallerg10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Rupanase Junior
Dosage Form : SOL
Dosage Strength : 1g/1ml
Packaging : 120X1g/1ml
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 : 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 : 10X1mg
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
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : RAZTROL
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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A Rinialer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rinialer, including repackagers and relabelers. The FDA regulates Rinialer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rinialer 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 Rinialer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rinialer supplier is an individual or a company that provides Rinialer active pharmaceutical ingredient (API) or Rinialer finished formulations upon request. The Rinialer suppliers may include Rinialer API manufacturers, exporters, distributors and traders.
click here to find a list of Rinialer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rinialer DMF (Drug Master File) is a document detailing the whole manufacturing process of Rinialer active pharmaceutical ingredient (API) in detail. Different forms of Rinialer DMFs exist exist since differing nations have different regulations, such as Rinialer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rinialer DMF submitted to regulatory agencies in the US is known as a USDMF. Rinialer USDMF includes data on Rinialer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rinialer USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Rinialer Drug Master File in Japan (Rinialer JDMF) empowers Rinialer 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 Rinialer JDMF during the approval evaluation for pharmaceutical products. At the time of Rinialer 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 Rinialer suppliers with JDMF on PharmaCompass.
A Rinialer CEP of the European Pharmacopoeia monograph is often referred to as a Rinialer Certificate of Suitability (COS). The purpose of a Rinialer CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rinialer EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rinialer to their clients by showing that a Rinialer CEP has been issued for it. The manufacturer submits a Rinialer CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rinialer CEP holder for the record. Additionally, the data presented in the Rinialer CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rinialer DMF.
A Rinialer CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rinialer 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 Rinialer suppliers with CEP (COS) on PharmaCompass.
A Rinialer written confirmation (Rinialer WC) is an official document issued by a regulatory agency to a Rinialer manufacturer, verifying that the manufacturing facility of a Rinialer active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rinialer APIs or Rinialer finished pharmaceutical products to another nation, regulatory agencies frequently require a Rinialer WC (written confirmation) as part of the regulatory process.
click here to find a list of Rinialer 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 Rinialer as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rinialer 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 Rinialer 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 Rinialer and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rinialer NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rinialer suppliers with NDC on PharmaCompass.
Rinialer 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 Rinialer 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 Rinialer GMP manufacturer or Rinialer GMP API supplier for your needs.
A Rinialer CoA (Certificate of Analysis) is a formal document that attests to Rinialer's compliance with Rinialer specifications and serves as a tool for batch-level quality control.
Rinialer CoA mostly includes findings from lab analyses of a specific batch. For each Rinialer 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.
Rinialer may be tested according to a variety of international standards, such as European Pharmacopoeia (Rinialer EP), Rinialer JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rinialer USP).
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