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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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About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...
Fujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.
About the Company : Fujian Genohope Biotech Ltd, established in 2019, specializes in high-potency polypeptide APIs and provides global API and preparation manufacturing services. Co-founded by New Hop...
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
About the Company : Vtides Life Sciences Pvt Ltd specializes in the design and synthesis of complex peptides using advanced chemical approaches, including microwave-assisted solid-phase synthesis. The...
About the Company : Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, an...
Space Peptides Pharmaceutical delivers Peptide CRDMO Services at Premium Speed & Quality to transform healthcare worldwide.
About the Company : Space Peptides Pharmaceutical is a Swiss-Chinese company headquartered in Bern, Switzerland. We provides a full range of pharmaceutical peptide CDMO services and a portfolio of gen...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
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CAS Number : 866044-63-5
End Use API : Tirzepatide
About The Company : CongenPharma, founded in 2013 and headquartered in Guangzhou, is a leading manufacturer of pharmaceutical peptide intermediates, cosmetic peptides, and ingredie...

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,...

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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

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Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 5MG/0.5ML (5MG/0.5ML)
Packaging :
Approval Date : 2022-05-13
Application Number : 215866
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 7.5MG/0.5ML (7.5MG/0.5ML)
Packaging :
Approval Date : 2022-05-13
Application Number : 215866
Regulatory Info : RX
Registration Country : USA

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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

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Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 12.5MG/0.5ML (12.5MG/0.5ML)
Packaging :
Approval Date : 2022-05-13
Application Number : 215866
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 15MG/0.5ML (15MG/0.5ML)
Packaging :
Approval Date : 2022-05-13
Application Number : 215866
Regulatory Info : RX
Registration Country : USA

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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

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Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 5MG/0.5ML (5MG/0.5ML)
Packaging :
Approval Date : 2023-07-28
Application Number : 215866
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 7.5MG/0.5ML (7.5MG/0.5ML)
Packaging :
Approval Date : 2023-07-28
Application Number : 215866
Regulatory Info : RX
Registration Country : USA

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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

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RLD : Yes
TE Code :
Brand Name : ZEPBOUND (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 5MG/0.5ML (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 : 7.5MG/0.5ML (7.5MG/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 : 10MG/0.5ML (10MG/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 : 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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RLD : Yes
TE Code :
Brand Name : ZEPBOUND
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10MG/0.5ML (10MG/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 : 12.5MG/0.5ML (12.5MG/0.5ML)
Approval Date : 2024-03-28
Application Number : 217806
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Mounjaro Kwikpen
Dosage Form : Solution For Injection
Dosage Strength : 15mg/dose
Packaging :
Approval Date : 22/04/2024
Application Number : 20231004000077
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Mounjaro Kwikpen
Dosage Form : Solution For Injection
Dosage Strength : 7.5mg/dose
Packaging :
Approval Date : 22/04/2024
Application Number : 20231004000046
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mounjaro
Dosage Form : Solution For Injection
Dosage Strength : 10mg/5ml
Packaging :
Approval Date : 02/11/2022
Application Number : 68726
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mounjaro
Dosage Form : Solution For Injection
Dosage Strength : 2.5mg/5ml
Packaging :
Approval Date : 09/07/2024
Application Number : 69415
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mounjaro
Dosage Form : Solution For Injection
Dosage Strength : 12.5mg/5ml
Packaging :
Approval Date : 09/07/2024
Application Number : 69415
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mounjaro KwikPen
Dosage Form : Injectable Solution In Pre-Filled Pen
Dosage Strength : 5mg/0.6ml
Packaging :
Approval Date : 26/06/2025
Application Number : 69696
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Mounjaro KwikPen
Dosage Form : Injectable Solution In A Pre-Filled Pen
Dosage Strength : 15mg/0.6ml
Packaging :
Approval Date : 26/06/2025
Application Number : 69696
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mounjaro
Dosage Form : Injectable Solution In Pre-Filled Pen
Dosage Strength : 5MG
Packaging :
Approval Date : 2024-04-30
Application Number : 1221685051
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mounjaro
Dosage Form : Injectable Solution In Vial
Dosage Strength : 5MG
Packaging :
Approval Date : 2024-02-09
Application Number : 1221685029
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Mounjaro
Dosage Form : Injectable Solution In Pre-Filled Pen
Dosage Strength : 2.5MG
Packaging :
Approval Date : 2024-04-30
Application Number : 1221685049
Regulatory Info : Authorized
Registration Country : Spain

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Patents & EXCLUSIVITIES
Patent Expiration Date : 2039-06-14
US Patent Number : 11357820
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215866
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-06-14

Patent Expiration Date : 2039-06-14
US Patent Number : 11357820
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215866
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-06-14

Patent Expiration Date : 2039-07-22
US Patent Number : 12343382
Drug Substance Claim :
Drug Product Claim :
Application Number : 215866
Patent Use Code : U-4232
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-07-22

Patent Expiration Date : 2039-07-22
US Patent Number : 12343382
Drug Substance Claim :
Drug Product Claim :
Application Number : 217806
Patent Use Code : U-4228
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-07-22

Patent Expiration Date : 2041-12-30
US Patent Number : 12295987
Drug Substance Claim :
Drug Product Claim :
Application Number : 215866
Patent Use Code : U-4192
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2041-12-30

Patent Expiration Date : 2039-06-14
US Patent Number : 11357820
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217806
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-06-14

Patent Expiration Date : 2039-07-22
US Patent Number : 12343382
Drug Substance Claim :
Drug Product Claim :
Application Number : 215866
Patent Use Code : U-4232
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-07-22

Patent Expiration Date : 2039-07-22
US Patent Number : 12343382
Drug Substance Claim :
Drug Product Claim :
Application Number : 217806
Patent Use Code : U-4228
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-07-22

Patent Expiration Date : 2041-12-30
US Patent Number : 12295987
Drug Substance Claim :
Drug Product Claim :
Application Number : 215866
Patent Use Code : U-4192
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2041-12-30

Patent Expiration Date : 2036-01-05
US Patent Number : 9474780
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217806
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-01-05

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