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1. (5s,6s,9r)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5h-cyclohepta(b)pyridin-9-yl 4-(2-oxo-2,3-dihydro-1h-imidazo(4,5-b)pyridin-1-yl)piperidine-1-carboxylate
2. Bms-927711
3. Nurtec Odt
4. Rimegepant
1. Nurtec Odt
2. Rimegepant Sulfate [usan]
3. 1374024-48-2
4. 1383nm3q0h
5. Rimegepant Sulfate (usan)
6. 1-piperidinecarboxylic Acid, 4-(2,3-dihydro-2-oxo-1h-imidazo(4,5-b)pyridin-1-yl)-, (5s,6s,9r)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5h-cyclohepta(b)pyridin-9-yl Ester, Sulfate, Hydrate (2:1:3)
7. Di((5s,6s,9r)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5h-cyclohepta(b)pyridin-9-yl 4-(2-oxo-2,3-dihydro-1h-imidazo(4,5-b)pyridin-1-yl)piperidine-1-carboxylate), Monosulfate, Trihydrate
8. Unii-1383nm3q0h
9. Nurtec Odt (tn)
10. Rimegepant Sulfate Dihydrate
11. Chembl2364629
12. Dtxsid60160174
13. Rimegepant Sulfate [who-dd]
14. Rimegepant Sulfate [orange Book]
15. Rimegepant Hemisulfate Sesquihydrate
16. D10663
17. Rimegepant Hemisulfate Sesquihydrate [mi]
18. Q27251488
Molecular Weight | 1221.2 g/mol |
---|---|
Molecular Formula | C56H64F4N12O13S |
Hydrogen Bond Donor Count | 9 |
Hydrogen Bond Acceptor Count | 23 |
Rotatable Bond Count | 8 |
Exact Mass | 1220.43726396 g/mol |
Monoisotopic Mass | 1220.43726396 g/mol |
Topological Polar Surface Area | 313 Ų |
Heavy Atom Count | 86 |
Formal Charge | 0 |
Complexity | 973 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 6 |
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-14
Pay. Date : 2023-09-26
DMF Number : 37797
Submission : 2022-12-23
Status : Active
Type : II
NDC Package Code : 81912-0002
Start Marketing Date : 2023-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41624
Submission : 2025-03-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-08-14
DMF Number : 38715
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-21
Pay. Date : 2023-09-27
DMF Number : 38834
Submission : 2023-09-29
Status : Active
Type : II
NDC Package Code : 69766-112
Start Marketing Date : 2023-09-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-14
Pay. Date : 2023-09-26
DMF Number : 37797
Submission : 2022-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41624
Submission : 2025-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-15
DMF Number : 38810
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-25
Pay. Date : 2023-08-24
DMF Number : 38655
Submission : 2023-08-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-21
Pay. Date : 2023-09-27
DMF Number : 38834
Submission : 2023-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-08-14
DMF Number : 38715
Submission : 2023-09-28
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-09-15
Written Confirmation Number : WC-0536
Address of the Firm : #49, F1 & F2, Canara Bank Road, Bommasandra Industrial area, Phase 1, Bommasandr...
Date of Issue : 2022-06-06
Valid Till : 2025-06-05
Written Confirmation Number : WC-0523
Address of the Firm : Unit-II, No. 276-P & 277-P, Sy no.20, Bannikuppe Road, Harohalli Industrial area...
Rimegepant Sulphate (BHV-3000)/FCI 3582 IH
Date of Issue : 2022-06-29
Valid Till : 2025-02-07
Written Confirmation Number : WC-0123
Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandai, Sangareddy District, T...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2025-03-24
Registration Number : Number 87-41-ND
Manufacturer Name : Anthem Biosciences Private L...
Manufacturer Address : No. 49, F1 & F2 Canara Bank Road, BommasandraIndustrial Area, Phase I, Bommasandra, B...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2025-03-24
Registration Number : Number 87-42-ND
Manufacturer Name : Anthem Biosciences Private L...
Manufacturer Address : No.276-P & 277-P, SY No. 20, Bannikuppe Road, Harohalli Industrial Area, Phase II, Ka...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2025-03-24
Registration Number : Number 87-43-ND
Manufacturer Name : Escientia Advanced Sciences ...
Manufacturer Address : Plot No.11, 11A, 12 and 12A, APSEZ, Atchutapuram, Anakapalli District - 531011, Andhr...
NDC Package Code : 81912-0002
Start Marketing Date : 2023-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-884
Start Marketing Date : 2024-01-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69989-0013
Start Marketing Date : 2020-10-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 69989-0009
Start Marketing Date : 2019-09-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 69989-0010
Start Marketing Date : 2019-09-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 69989-0012
Start Marketing Date : 2021-08-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 69989-0011
Start Marketing Date : 2021-04-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 72804-0004
Start Marketing Date : 2023-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69766-112
Start Marketing Date : 2023-09-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65085-0081
Start Marketing Date : 2021-10-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Details:
Vydura (also known as Rimegepant) is an oral lyophilisate and is the first calcitonin gene-related peptide (CGRP) receptor antagonist migraine therapy to be accepted by the SMC.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Vydura
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Biohaven Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 05, 2023
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Biohaven Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
First-In-Class Migraine Treatment Vydura Approved for NHS Scotland
Details : Vydura (also known as Rimegepant) is an oral lyophilisate and is the first calcitonin gene-related peptide (CGRP) receptor antagonist migraine therapy to be accepted by the SMC.
Product Name : Vydura
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 05, 2023
Details:
Pfizer will acquire Biohaven, the maker of NURTEC® ODT (rimegepant sulfate). Pfizer will commercialize NURTEC® ODT, an innovative compound for the prevention and acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition October 05, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $11,600.0 million
Deal Type : Acquisition
Pfizer to Acquire Biohaven Pharmaceuticals
Details : Pfizer will acquire Biohaven, the maker of NURTEC® ODT (rimegepant sulfate). Pfizer will commercialize NURTEC® ODT, an innovative compound for the prevention and acute treatment of migraine.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : $11,600.0 million
October 05, 2022
Details:
Results from long-term studies of Nurtec ODT (Rimegepant Sulfate) as a preventive and acute treatment of migraine showed more than 80% of patients achieved ≥50% reduction in moderate or severe monthly migraine days and approximately half experienced a 100% reduction.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 06, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven Underscores Depth of Migraine Portfolio with Data from Nurtec® ODT (rimegepant) Long-Ter...
Details : Results from long-term studies of Nurtec ODT (Rimegepant Sulfate) as a preventive and acute treatment of migraine showed more than 80% of patients achieved ≥50% reduction in moderate or severe monthly migraine days and approximately half experienced a ...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 06, 2022
Details:
Results demonstrate a clinically meaningful reduction in opioid use of Nurtec® ODT (rimegepant) for patient population and may be of benefit to those reliant on opioids to manage their disease, thereby alleviating potential negative consequences of opioid use.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven Presentation at AAN Showed Decreased Opioid Use in Migraine Patients Following Nurtec® O...
Details : Results demonstrate a clinically meaningful reduction in opioid use of Nurtec® ODT (rimegepant) for patient population and may be of benefit to those reliant on opioids to manage their disease, thereby alleviating potential negative consequences of opio...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 04, 2022
Details:
The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of regulatory approvals and the satisfaction of other customary conditions and BHVN shares have been issued to Pfizer.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $1,240.0 million Upfront Cash: $500.0 million
Deal Type: Collaboration May 01, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $1,240.0 million
Deal Type : Collaboration
Details : The transaction agreements, including Pfizer’s commercialization of rimegepant and zavegepant outside of the U.S., have become effective following the receipt of regulatory approvals and the satisfaction of other customary conditions and BHVN shares ha...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : $500.0 million
May 01, 2022
Details:
Results from the Phase 3 study published in Lancet demonstrated that a single dose of rimegepant provided superior pain reduction and associated symptoms of migraine at two hours compared to placebo.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 27, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Pfizer and Biohaven’s Vydura® (Rimegepant) Granted First Ever Marketing Authorization by Europe...
Details : Results from the Phase 3 study published in Lancet demonstrated that a single dose of rimegepant provided superior pain reduction and associated symptoms of migraine at two hours compared to placebo.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 27, 2022
Details:
The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including NURTEC® ODT (rimegepant), to address needs of millions of migraine patients worldwide.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: $11,600.0 million Upfront Cash: $11,600.0 million
Deal Type: Acquisition March 10, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : $11,600.0 million
Deal Type : Acquisition
Pfizer Completes Acquisition of Biohaven Pharmaceuticals
Details : The acquisition brings to Pfizer a portfolio of promising calcitonin gene-related peptide (CGRP) receptor antagonists including NURTEC® ODT (rimegepant), to address needs of millions of migraine patients worldwide.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : $11,600.0 million
March 10, 2022
Details:
The CHMP of the EMA adopted a positive opinion for rimegepant, a CGRP receptor antagonist and, will now be reviewed by the European Commission, whose EU trade name will be VYDURA and it will be valid in all 27 EU member states for the treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 25, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven and Pfizer Receive Positive CHMP Opinion for Migraine Treatment
Details : The CHMP of the EMA adopted a positive opinion for rimegepant, a CGRP receptor antagonist and, will now be reviewed by the European Commission, whose EU trade name will be VYDURA and it will be valid in all 27 EU member states for the treatment of migrai...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 25, 2022
Details:
Nurtec ODT, oral calcitonin-gene related peptide receptor antagonist currently approved for the acute and preventive treatment of migraine. Prior research has implicated CGRP in pathophysiology of disease and suggested therapeutic benefits of CGRP antagonism.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Nurtec ODT
Study Phase: Phase II/ Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 22, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Biohaven Enrolls First Patient in Phase 2/3 Sinusitis Trial of Nurtec® ODT
Details : Nurtec ODT, oral calcitonin-gene related peptide receptor antagonist currently approved for the acute and preventive treatment of migraine. Prior research has implicated CGRP in pathophysiology of disease and suggested therapeutic benefits of CGRP antago...
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 22, 2022
Details:
NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine.
Lead Product(s): Rimegepant Sulfate
Therapeutic Area: Neurology Brand Name: Nurtec ODT
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 14, 2022
Lead Product(s) : Rimegepant Sulfate
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine.
Product Name : Nurtec ODT
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 14, 2022
(6S,9R)-6-(2,3-Difluorophenyl)-6,7,8,9-tetrahydro-...
CAS Number : 1190363-46-2
End Use API : Rimegepant Sulfate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
1-piperidin-4-yl-3H-imidazo[4,5-b]pyridin-2-one,di...
CAS Number : 781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
2-oxo-1-(4-piperidinyl)-2,3- dihydro-1H-imidazo[4,...
CAS Number : 781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
9-((triisopropylsilyl)oxy)-6,7,8,9- tetrahydro-5Hc...
CAS Number : 1190363-45-1
End Use API : Rimegepant Sulfate
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
1-(PIPERIDIN-4-YL)-1,3-DIHYDRO-2H-IMIDAZO[4,5-B] ...
CAS Number : 781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
CAS Number : 3612-20-2
End Use API : Rimegepant Sulfate
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
CAS Number : 5382-16-1
End Use API : Rimegepant Sulfate
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
ETHYL 4-OXOPIPERIDINE-1-CARBOXYLATE / N-CARBETHOX...
CAS Number : 29976-53-2
End Use API : Rimegepant Sulfate
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
Dimethyl-5,9-dihydroxy-7H-cyclohepta [?] pyridine-...
CAS Number : 39713-36-5
End Use API : Rimegepant Sulfate
About The Company : Established in 2016, a state-of-the-art R&D facility engaged in the development of Novel processes for Bulk Actives including Deuterated Actives, Advanced Inter...
7,8-dihydro-5H-cyclohepta[b]pyridine-5,9(6H)-dione
CAS Number : 39713-40-1
End Use API : Rimegepant Sulfate
About The Company : Established in 2016, a state-of-the-art R&D facility engaged in the development of Novel processes for Bulk Actives including Deuterated Actives, Advanced Inter...
Regulatory Info : RX
Registration Country : USA
Brand Name : NURTEC ODT
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : EQ 75MG BASE
Packaging :
Approval Date : 2020-02-27
Application Number : 212728
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
RLD : Yes
TE Code :
Brand Name : NURTEC ODT
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : EQ 75MG BASE
Approval Date : 2020-02-27
Application Number : 212728
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Vydura ODT
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
https://www.pharmacompass.com/radio-compass-blog/fda-approvals-rise-49-in-2023-crispr-s-gene-editing-therapy-sees-light-of-day
11 Jun 2024
// Fraiser Kansteiner FIERCE PHARMA
https://www.fiercepharma.com/pharma/pfizer-ceo-says-company-needs-take-breathing-period-after-massive-ma-stretch
https://www.pharmacompass.com/pdf/news/fda-confirms-para-iv-patent-litigation-for-rimegepant-sulfate-nurtec-odt-tablets-71965.pdf
09 Apr 2024
// Beth Snyder Bulik ENDPTS
https://endpts.com/lady-gaga-returns-in-a-new-nurtec-migraine-ad-for-pfizer/
13 Sep 2023
// Kevin Dunleavy FIERCE PHARMA
https://www.fiercepharma.com/pharma/late-party-nice-finally-signs-pfizers-nurtec-treat-migraine-attacks
17 Jun 2023
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/eli-lillys-migraine-drug-fails-meet-main-goal-post-approval-study-2023-06-16/
01 Jun 2023
// Paul Schloesser ENDPTS
https://endpts.com/nice-recommends-pfizer-migraine-drug-in-uk-with-restrictions/
Global Sales Information
Company : Biohaven Pharma
Rimegepant Sulfate
Drug Cost (USD) : 478,240,312
Year : 2023
Prescribers : 83811
Prescriptions : 329578
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Biohaven Pharma
Rimegepant Sulfate
Drug Cost (USD) : 276,493,155
Year : 2022
Prescribers : 56513
Prescriptions : 207402
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Biohaven Pharma
Rimegepant Sulfate
Drug Cost (USD) : 118,402,787
Year : 2021
Prescribers : 32315
Prescriptions : 104314
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Biohaven Pharma
Rimegepant Sulfate
Drug Cost (USD) : 18,933,232
Year : 2020
Prescribers : 8957
Prescriptions : 19444
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Price Per Pack (Euro) : 50.61
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Price Per Pack (Euro) : 202.53
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Schmelztabl
Dosage Strength : 75mg
Price Per Pack (Euro) : 404.89
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Main Therapeutic Indication : Neurology
Currency : USD
2022 Revenue in Millions : 213
2021 Revenue in Millions : 0
Growth (%) : 100
Main Therapeutic Indication : Neurology
Currency : USD
2023 Revenue in Millions : 928
2022 Revenue in Millions : 213
Growth (%) : 336
Main Therapeutic Indication : Neurology
Currency : USD
2024 Revenue in Millions : 1,263
2023 Revenue in Millions : 928
Growth (%) : 36
Market Place
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15 Sep 2020
Patents & EXCLUSIVITIES
Exclusivity Code : NCE
Exclusivity Expiration Date : 2025-02-27
Application Number : 212728
Product Number : 1
Exclusivity Details :
ABOUT THIS PAGE
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PharmaCompass offers a list of Rimegepant Sulfate 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 Rimegepant Sulfate manufacturer or Rimegepant Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rimegepant Sulfate manufacturer or Rimegepant Sulfate supplier.
PharmaCompass also assists you with knowing the Rimegepant Sulfate API Price utilized in the formulation of products. Rimegepant Sulfate API Price is not always fixed or binding as the Rimegepant Sulfate Price is obtained through a variety of data sources. The Rimegepant Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rimegepant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimegepant, including repackagers and relabelers. The FDA regulates Rimegepant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimegepant 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 Rimegepant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rimegepant supplier is an individual or a company that provides Rimegepant active pharmaceutical ingredient (API) or Rimegepant finished formulations upon request. The Rimegepant suppliers may include Rimegepant API manufacturers, exporters, distributors and traders.
click here to find a list of Rimegepant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rimegepant DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimegepant active pharmaceutical ingredient (API) in detail. Different forms of Rimegepant DMFs exist exist since differing nations have different regulations, such as Rimegepant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimegepant DMF submitted to regulatory agencies in the US is known as a USDMF. Rimegepant USDMF includes data on Rimegepant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimegepant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimegepant 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 Rimegepant Drug Master File in Korea (Rimegepant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rimegepant. The MFDS reviews the Rimegepant KDMF as part of the drug registration process and uses the information provided in the Rimegepant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rimegepant 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 Rimegepant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rimegepant suppliers with KDMF on PharmaCompass.
A Rimegepant written confirmation (Rimegepant WC) is an official document issued by a regulatory agency to a Rimegepant manufacturer, verifying that the manufacturing facility of a Rimegepant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rimegepant APIs or Rimegepant finished pharmaceutical products to another nation, regulatory agencies frequently require a Rimegepant WC (written confirmation) as part of the regulatory process.
click here to find a list of Rimegepant 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 Rimegepant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rimegepant 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 Rimegepant 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 Rimegepant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rimegepant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rimegepant suppliers with NDC on PharmaCompass.
Rimegepant 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 Rimegepant 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 Rimegepant GMP manufacturer or Rimegepant GMP API supplier for your needs.
A Rimegepant CoA (Certificate of Analysis) is a formal document that attests to Rimegepant's compliance with Rimegepant specifications and serves as a tool for batch-level quality control.
Rimegepant CoA mostly includes findings from lab analyses of a specific batch. For each Rimegepant 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.
Rimegepant may be tested according to a variety of international standards, such as European Pharmacopoeia (Rimegepant EP), Rimegepant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rimegepant USP).