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Weekly News Recap #Phispers
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39465
Submission : 2024-02-06
Status : Active
Type : II
NDC Package Code : 76177-023
Start Marketing Date : 2023-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40115
Submission : 2024-07-18
Status : Active
Type : II
NDC Package Code : 0002-0770
Start Marketing Date : 2023-06-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 82891-022
Start Marketing Date : 2024-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 14403-0020
Start Marketing Date : 2024-06-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 14403-0017
Start Marketing Date : 2024-04-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 73569-050
Start Marketing Date : 2023-12-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 84789-102
Start Marketing Date : 2024-10-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 86184-392
Start Marketing Date : 2024-03-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 84385-101
Start Marketing Date : 2024-09-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (100g/100g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 83783-001
Start Marketing Date : 2024-11-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 82907-897
Start Marketing Date : 2023-09-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50g/50g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
2-(2-(2-AMINOETHOXY)ETHOXY)ACETIC ACID HYDROCHLORI...
CAS Number : 134979-01-4
End Use API : Tirzepatide
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...
17-amino-10-oxo-3,6,12,15-tetraoxa-9-azaheptadecan...
CAS Number : 1143516-05-5
End Use API : Tirzepatide
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...
2,2-Dimethyl-4,13-dioxo-3,8,11,17,20-pentaoxa-5,14...
CAS Number : 1069067-08-8
End Use API : Tirzepatide
About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...
Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML)
Packaging :
Approval Date : 2022-05-13
Application Number : 215866
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10MG/0.5ML (10MG/0.5ML)
Packaging :
Approval Date : 2022-05-13
Application Number : 215866
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML)
Packaging :
Approval Date : 2023-07-28
Application Number : 215866
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10MG/0.5ML (10MG/0.5ML)
Packaging :
Approval Date : 2023-07-28
Application Number : 215866
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEPBOUND (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML)
Packaging :
Approval Date : 2023-11-08
Application Number : 217806
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEPBOUND (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10MG/0.5ML (10MG/0.5ML)
Packaging :
Approval Date : 2023-11-08
Application Number : 217806
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEPBOUND
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML)
Packaging :
Approval Date : 2024-03-28
Application Number : 217806
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEPBOUND
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10MG/0.5ML (10MG/0.5ML)
Packaging :
Approval Date : 2024-03-28
Application Number : 217806
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Mounjaro
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 2.5 mg
Packaging : Pre-filled pen 4 0.5ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541041
Regulatory Info :
Registration Country : Canada
RLD : Yes
TE Code :
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML)
Approval Date : 2022-05-13
Application Number : 215866
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 5MG/0.5ML (5MG/0.5ML)
Approval Date : 2022-05-13
Application Number : 215866
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 7.5MG/0.5ML (7.5MG/0.5ML)
Approval Date : 2022-05-13
Application Number : 215866
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10MG/0.5ML (10MG/0.5ML)
Approval Date : 2022-05-13
Application Number : 215866
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 12.5MG/0.5ML (12.5MG/0.5ML)
Approval Date : 2022-05-13
Application Number : 215866
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEPBOUND (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10MG/0.5ML (10MG/0.5ML)
Approval Date : 2023-11-08
Application Number : 217806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEPBOUND (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 12.5MG/0.5ML (12.5MG/0.5ML)
Approval Date : 2023-11-08
Application Number : 217806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEPBOUND (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 15MG/0.5ML (15MG/0.5ML)
Approval Date : 2023-11-08
Application Number : 217806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEPBOUND
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML (2.5MG/0.5ML)
Approval Date : 2024-03-28
Application Number : 217806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : ZEPBOUND
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 5MG/0.5ML (5MG/0.5ML)
Approval Date : 2024-03-28
Application Number : 217806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Regulatory Info :
Registration Country : Norway
Brand Name : Mounjaro
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 2.5 mg
Packaging : Pre-filled pen 4 0.5ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Mounjaro
Dosage Form : Solution for injection in a pre-filled pen
Dosage Strength : 5 mg
Packaging : Pre-filled pen 4 0.5ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Mounjaro
Dosage Form : Solution for injection
Dosage Strength : 2.5 mg
Packaging : Vials 1 0.5ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
02 Jan 2025
// FIERCE PHARMA
https://www.fiercepharma.com/marketing/lillys-zepbound-expected-surpass-novos-wegovy-dominate-obesity-market-globaldata
02 Jan 2025
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-asks-join-lawsuit-over-compounded-versions-its-weight-loss-drugs-2025-01-02/
02 Jan 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/lilly-looks-wade-legal-fracas-between-fda-and-compounders-following-end-tirzepatide-shortage
26 Dec 2024
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/lilly-obesity-drug-mounjaro-be-offered-britains-nhs-after-watchdog-nod-2024-12-23/
23 Dec 2024
// FDA
https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea
20 Dec 2024
// BIOSPACE
https://www.biospace.com/business/fda-still-undecided-about-shortage-status-of-lillys-tirzepatide
Global Sales Information
Dosage Form : Solution for injection
Dosage Strength : 2.5 mg
Price Per Pack (Euro) : 50.14
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Solution for injection in a pre-...
Dosage Strength : 2.5 mg
Price Per Pack (Euro) : 200.54
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Solution for injection in a pre-...
Dosage Strength : 5 mg
Price Per Pack (Euro) : 200.54
Published in :
Country : Norway
RX/OTC/DISCN :
Main Therapeutic Indication : Diabetes
Currency : USD
2022 Revenue in Millions : 483
2021 Revenue in Millions : 0
Growth (%) : New Launch in 2022
Main Therapeutic Indication : Diabetes
Currency : USD
2023 Revenue in Millions : 5,163
2022 Revenue in Millions : 483
Growth (%) : 970
Main Therapeutic Indication : Nutritional Deficiency
Currency : USD
2023 Revenue in Millions : 176
2022 Revenue in Millions : 0
Growth (%) : New Launch
Market Place
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