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Molecular Weight | 604.7 g/mol |
---|---|
Molecular Formula | C18H31GdN4O9 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 13 |
Rotatable Bond Count | 2 |
Exact Mass | 605.13321 g/mol |
Monoisotopic Mass | 605.13321 g/mol |
Topological Polar Surface Area | 194 A^2 |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 555 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-06-23
DMF Number : 33420
Submission : 2019-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13061
Submission : 1998-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40533
Submission : 2024-09-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36660
Submission : 2021-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-13
DMF Number : 39149
Submission : 2023-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-06-19
Pay. Date : 2020-04-29
DMF Number : 34832
Submission : 2020-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-25
Pay. Date : 2023-08-29
DMF Number : 36996
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38579
Submission : 2023-08-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-30
Pay. Date : 2021-02-26
DMF Number : 35662
Submission : 2021-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-09
Pay. Date : 2024-07-25
DMF Number : 39094
Submission : 2023-11-24
Status : Active
Type : II
559.8
11 - 50
6.1k
3.4M
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|---|---|---|
TURKEY | 4,906.16 | 551.0 | 11 - 50 |
INDIA | 444.30 | 577.0 | 11 - 50 |
CHINA | 643.12 | 592.4 | <10 |
GERMANY | 93.00 | 587.0 | <10 |
INDIA | 6.00 | 2,549.1 | <10 |
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RLD : Yes
TE Code : AP
Brand Name : GADAVIST
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 18.1416GM/30ML (604.72MG/ML)
Approval Date : 2011-03-14
Application Number : 201277
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : GADAVIST
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 39.3068GM/65ML (604.72MG/ML)
Approval Date : 2011-03-14
Application Number : 201277
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : GADAVIST
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1.20944GM/2ML (604.72MG/ML)
Approval Date : 2013-12-18
Application Number : 201277
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GADOBUTROL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 4.5354GM/7.5ML (604.72MG/ML)
Approval Date : 2023-03-15
Application Number : 217480
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : GADOBUTROL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 9.0708GM/15ML (604.72MG/ML)
Approval Date : 2023-03-15
Application Number : 217480
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD :
TE Code :
Brand Name : GADOBUTROL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1.20944GM/2ML (604.72MG/ML)
Approval Date :
Application Number : 215061
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : GADOBUTROL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 4.5354GM/7.5ML (604.72MG/ML)
Approval Date :
Application Number : 215061
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : GADOBUTROL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 6.0472GM/10ML (604.72MG/ML)
Approval Date :
Application Number : 215061
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : GADOBUTROL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 9.0708GM/15ML (604.72MG/ML)
Approval Date :
Application Number : 215061
RX/OTC/DISCN :
RLD :
TE Code :
RLD : No
TE Code : AP
Brand Name : GADOBUTROL
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 6.0472GM/10ML (604.72MG/ML)
Approval Date : 2022-11-17
Application Number : 216081
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
Regulatory Info :
Registration Country : Sweden
Brand Name : Gadovist
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 1.0 MMOL / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Gadovist
Dosage Form : Gadobutrol 30Mmol 30Ml 1 Units Parenteral Use
Dosage Strength : 1 vial EV 30 ml 1 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Gadovist
Dosage Form : Gadobutrol 30Mmol 30Ml 1 Units Parenteral Use
Dosage Strength : 1 cartridge 30 ml 1,0 mmol/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Gadovist
Dosage Form : Injection fluid, resolution
Dosage Strength : 1 mmol/ml
Packaging : Finish filled syringe of glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Gadovist
Dosage Form : Injection fluid, resolution
Dosage Strength : 1 mmol/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Gadovist
Dosage Form : Injection fluid, resolution
Dosage Strength : 1 mmol/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Gadovist 1.0
Dosage Form : Inj L?s
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Gadovist 1.0
Dosage Form : Inj. L?s
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Gadovist 1.0
Dosage Form : Inj L?s
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Gadovist 1.0
Dosage Form : Inj L?s
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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Global Sales Information
Dosage Form : Gadobutrol 10Mmol 10Ml 1 Units P...
Dosage Strength : 1 syringe 10 ml 1,0 mmol/ml
Price Per Pack (Euro) : 126.08
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Gadobutrol 15Mmol 15Ml 1 Units P...
Dosage Strength : 1 vial EV 15 ml 1,0 mmol/ml
Price Per Pack (Euro) : 189.02
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Gadobutrol 2Mmol 2Ml 3 Units' Pa...
Dosage Strength : 3 VIALS EV 2 ml 1 mmol/ml
Price Per Pack (Euro) : 75.62
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Gadobutrol 30Mmol 30Ml 1 Units P...
Dosage Strength : 1 vial EV 30 ml 1 mmol/ml
Price Per Pack (Euro) : 378.05
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Gadobutrol 30Mmol 30Ml 1 Units P...
Dosage Strength : 1 cartridge 30 ml 1,0 mmol/ml
Price Per Pack (Euro) : 378.05
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Gadobutrol 7,5Mmol 7,5Ml 1 Unit ...
Dosage Strength : 1 syringe 7,5 ml 1,0 mmol/ml
Price Per Pack (Euro) : 94.61
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Inj L?s
Dosage Strength :
Price Per Pack (Euro) : 210.42
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Inj L?s
Dosage Strength :
Price Per Pack (Euro) : 72.43
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Inj L?s
Dosage Strength :
Price Per Pack (Euro) : 82.09
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Dosage Form : Inj L?s
Dosage Strength :
Price Per Pack (Euro) : 14.02
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Main Therapeutic Indication : Diagnostics
Currency : USD
2022 Revenue in Millions : 492
2021 Revenue in Millions : 460
Growth (%) : 7
Main Therapeutic Indication : Diagnostics
Currency : USD
2023 Revenue in Millions : 502
2022 Revenue in Millions : 492
Growth (%) : -1
Market Place
Reply
17 Dec 2022
Patents & EXCLUSIVITIES
Exclusivity Code : CGT
Exclusivity Expiration Date : 2024-04-29
Application Number : 216081
Product Number : 2
Exclusivity Details :
Exclusivity Code : CGT
Exclusivity Expiration Date : 2024-04-29
Application Number : 216081
Product Number : 1
Exclusivity Details :
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