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Weekly News Recap #Phispers
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Fujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40503
Submission : 2024-09-19
Status : Active
Type : II
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
Space Peptides Pharmaceutical delivers Peptide CRDMO Services at Premium Speed & Quality to transform healthcare worldwide.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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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 :

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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 :

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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 :

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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 :

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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 :

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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 :

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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 :

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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 :

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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 :

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RLD : Yes
TE Code :
Brand Name : ZEPBOUND
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 7.5MG/0.5ML (7.5MG/0.5ML)
Approval Date : 2024-03-28
Application Number : 217806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541041
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541068
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541076
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 12.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541092
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 15MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541106
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.6ML
Packaging :
Approval Date :
Application Number : 2551977
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 10MG/0.6ML
Packaging :
Approval Date :
Application Number : 2551985
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : MOUNJARO KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 15MG/0.6ML
Packaging :
Approval Date :
Application Number : 2552000
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ZEPBOUND KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.6ML
Packaging :
Approval Date :
Application Number : 2557509
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ZEPBOUND KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 10MG/0.6ML
Packaging :
Approval Date :
Application Number : 2557533
Regulatory Info : Prescription
Registration Country : Canada

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 5 mg KwikPen
Dosage Form : INJ
Dosage Strength : 5mg
Packaging : 1X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 2,5 mg KwikPen
Dosage Form : INJ
Dosage Strength : 2.5mg
Packaging : 1X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 7,5 mg KwikPen
Dosage Form : INJ
Dosage Strength : 7.5mg
Packaging : 1X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 10 mg KwikPen
Dosage Form : INJ
Dosage Strength : 10mg
Packaging : 1X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 12,5 mg KwikPen
Dosage Form : INJ
Dosage Strength : 12.5mg
Packaging : 1X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 15 mg KwikPen
Dosage Form : INJ
Dosage Strength : 15mg
Packaging : 1X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 2,5mg
Dosage Form : INJ
Dosage Strength : 2.5mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 5mg
Dosage Form : INJ
Dosage Strength : 5mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 7,5mg
Dosage Form : INJ
Dosage Strength : 7.5mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mounjaro 10mg
Dosage Form : INJ
Dosage Strength : 10mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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