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1. 4-amino-5-chloro-n-(1-(3-methoxypropyl)-4-piperidinyl)-2,3-dihydro-1-benzofuran-7-carboxamide
2. Motegrity
3. Prucalopride
4. R 093877
5. R093877
6. Resolor
7. Resotran
8. Resotrans
1. 179474-85-2
2. Resolor
3. Prucalopride Succinat
4. Prucalopride (succinate)
5. R-108512
6. Butanedioic Acid 4-amino-5-chloro-2,3-dihydro-n-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide
7. Prucalopride Succinate [usan]
8. Prucalopride (as Succinate)
9. 4v2g75e1ck
10. 179474-85-2 (succinate)
11. 4-amino-5-chloro-n-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide Succinate
12. Butanedioic Acid, Compd. With 4-amino-5-chloro-2,3-dihydro-n-(1-(3-methoxypropyl)-4-piperidinyl)-7-benzofurancarboxamide (1:1)
13. Butanedioic Acid, Compd. With 4-amino-5-chloro-2,3-dihydro-n-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide (1:1)
14. Prucalopride Succinate (usan)
15. Resotran
16. 4-amino-5-chloro-n-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide;butanedioic Acid
17. Resolor (tn)
18. Unii-4v2g75e1ck
19. R-93877
20. Resolor Succinate
21. Motegrity (tn)
22. Prucalopridesuccinate
23. R 108512
24. Mls006011219
25. Schembl1230437
26. Chembl2105748
27. Dtxsid701027749
28. Hms3652b21
29. Hms3885j13
30. Bcp09320
31. Mfcd00948731
32. S4247
33. Akos015994741
34. Prucalopride Succinate [mart.]
35. Ccg-269590
36. Cs-3907
37. Ks-1283
38. Prucalopride Succinate [who-dd]
39. 4-amino-5-chloro-n-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide,butanedioic Acid
40. Ac-29960
41. Butanedioic Acid 4-amino-5-chloro-2,3-dihydro-n-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarb
42. Hy-12694
43. Smr004702981
44. Db-065276
45. Prucalopride Succinate [orange Book]
46. Ft-0745512
47. Sw219198-1
48. D10152
49. A812449
50. J-519956
51. Q27260539
52. B0084-470898
| Molecular Weight | 486.0 g/mol |
|---|---|
| Molecular Formula | C22H32ClN3O7 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 9 |
| Exact Mass | 485.1928781 g/mol |
| Monoisotopic Mass | 485.1928781 g/mol |
| Topological Polar Surface Area | 151 Ų |
| Heavy Atom Count | 33 |
| Formal Charge | 0 |
| Complexity | 538 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Laxatives
Agents that produce a soft formed stool, and relax and loosen the bowels, typically used over a protracted period, to relieve CONSTIPATION. (See all compounds classified as Laxatives.)
Serotonin 5-HT4 Receptor Agonists
Endogenous compounds and drugs that specifically stimulate SEROTONIN 5-HT4 RECEPTORS. (See all compounds classified as Serotonin 5-HT4 Receptor Agonists.)
A06AX05
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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Regulatory Info :
Registration Country : Sweden
Brand Name : Resolor
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 1 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Resolor
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 2 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Resolor
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 1 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Resolor
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 1 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Resolor
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 1 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Resolor
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 2 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Resolor
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 2 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Resolor
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 2 mg
Packaging : Calendar Gasket
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Resolor
Dosage Form : Filmtabl
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Resolor
Dosage Form : Filmtabl
Dosage Strength : 2mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : RESOTRAN
Dosage Form : TABLET
Dosage Strength : 1MG
Packaging : 28
Approval Date :
Application Number : 2377012
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : RESOTRAN
Dosage Form : TABLET
Dosage Strength : 2MG
Packaging : 28
Approval Date :
Application Number : 2377020
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : APO-PRUCALOPRIDE
Dosage Form : TABLET
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 2491591
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : APO-PRUCALOPRIDE
Dosage Form : TABLET
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number : 2491605
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : JAMP PRUCALOPRIDE
Dosage Form : TABLET
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 2493489
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : JAMP PRUCALOPRIDE
Dosage Form : TABLET
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number : 2493497
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : NRA-PRUCALOPRIDE
Dosage Form : TABLET
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 2550377
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)
Brand Name : NRA-PRUCALOPRIDE
Dosage Form : TABLET
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number : 2550385
Regulatory Info : Prescription
Registration Country : Canada
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
Regulatory FDF Prices
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Main Therapeutic Indication : Gastrointestinal Disorders
Currency : USD
2019 Revenue in Millions : 50
2018 Revenue in Millions : 0
Growth (%) : New launch
Main Therapeutic Indication : Gastrointestinal Disorders
Currency : USD
2020 Revenue in Millions : 99
2019 Revenue in Millions : 51
Growth (%) : 93
Main Therapeutic Indication : Gastrointestinal Disorders
Currency : USD
2021 Revenue in Millions : 108
2020 Revenue in Millions : 95
Growth (%) : 23
Main Therapeutic Indication : Gastrointestinal Diseases
Currency : USD
2022 Revenue in Millions : 125
2021 Revenue in Millions : 108
Growth (%) : 16
Main Therapeutic Indication : Gastrointestinal Diseases
Currency : USD
2023 Revenue in Millions : 139
2022 Revenue in Millions : 126
Growth (%) : 25
Main Therapeutic Indication : Gastrointestinal Diseases
Currency : USD
2024 Revenue in Millions : 152
2023 Revenue in Millions : 139
Growth (%) : 10
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Patents & EXCLUSIVITIES
US Exclusivities
Exclusivity Code : CGT
Exclusivity Expiration Date : 2025-06-24
Application Number : 218492
Product Number : 1
Exclusivity Details :
Exclusivity Code : CGT
Exclusivity Expiration Date : 2025-06-24
Application Number : 218492
Product Number : 2
Exclusivity Details :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Prucalopride Succinate 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 Prucalopride Succinate manufacturer or Prucalopride Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prucalopride Succinate manufacturer or Prucalopride Succinate supplier.
PharmaCompass also assists you with knowing the Prucalopride Succinate API Price utilized in the formulation of products. Prucalopride Succinate API Price is not always fixed or binding as the Prucalopride Succinate Price is obtained through a variety of data sources. The Prucalopride Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prucalopride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prucalopride, including repackagers and relabelers. The FDA regulates Prucalopride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prucalopride 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 Prucalopride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prucalopride supplier is an individual or a company that provides Prucalopride active pharmaceutical ingredient (API) or Prucalopride finished formulations upon request. The Prucalopride suppliers may include Prucalopride API manufacturers, exporters, distributors and traders.
click here to find a list of Prucalopride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prucalopride DMF (Drug Master File) is a document detailing the whole manufacturing process of Prucalopride active pharmaceutical ingredient (API) in detail. Different forms of Prucalopride DMFs exist exist since differing nations have different regulations, such as Prucalopride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prucalopride DMF submitted to regulatory agencies in the US is known as a USDMF. Prucalopride USDMF includes data on Prucalopride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prucalopride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prucalopride suppliers with USDMF 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 Prucalopride Drug Master File in Korea (Prucalopride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prucalopride. The MFDS reviews the Prucalopride KDMF as part of the drug registration process and uses the information provided in the Prucalopride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prucalopride 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 Prucalopride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prucalopride suppliers with KDMF on PharmaCompass.
A Prucalopride written confirmation (Prucalopride WC) is an official document issued by a regulatory agency to a Prucalopride manufacturer, verifying that the manufacturing facility of a Prucalopride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prucalopride APIs or Prucalopride finished pharmaceutical products to another nation, regulatory agencies frequently require a Prucalopride WC (written confirmation) as part of the regulatory process.
click here to find a list of Prucalopride 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 Prucalopride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prucalopride 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 Prucalopride 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 Prucalopride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prucalopride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prucalopride suppliers with NDC on PharmaCompass.
Prucalopride 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 Prucalopride 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 Prucalopride GMP manufacturer or Prucalopride GMP API supplier for your needs.
A Prucalopride CoA (Certificate of Analysis) is a formal document that attests to Prucalopride's compliance with Prucalopride specifications and serves as a tool for batch-level quality control.
Prucalopride CoA mostly includes findings from lab analyses of a specific batch. For each Prucalopride 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.
Prucalopride may be tested according to a variety of international standards, such as European Pharmacopoeia (Prucalopride EP), Prucalopride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prucalopride USP).
