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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
NDC Package Code : 84502-103
Start Marketing Date : 2024-07-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Vtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.
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.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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
GDUFA
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DMF Number : 38773
Submission : 2023-08-30
Status : Active
Type : II
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DMF Number : 40481
Submission : 2024-12-10
Status : Active
Type : II
GDUFA
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DMF Number : 40123
Submission : 2024-07-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40378
Submission : 2024-12-11
Status : Active
Type : II
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DMF Number : 39465
Submission : 2024-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40115
Submission : 2024-07-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39655
Submission : 2024-03-17
Status : Active
Type : II
USDMF
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DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39900
Submission : 2024-06-28
Status : Active
Type : II
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Rev. Date :
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DMF Number : 39611
Submission : 2024-02-28
Status : Active
Type : II
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Registrant Name : Korea Lily (U.S.)
Registration Date : 2023-06-28
Registration Number : Su253-11-ND
Manufacturer Name : Corden Pharma Colorado, Inc.
Manufacturer Address : 2075 55th Street, Boulder, Colorado (CO) 80301, United States (USA)
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-04-17
Registration Number : No. 6199-4-ND
Manufacturer Name : Hybio Pharmaceutical (Wuhan)...
Manufacturer Address : No. 9 Linkong West Street, Hengdian Street, Huangpi District, Wuhan City, Hubei 43030...
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2025-05-19
Registration Number : 434-73-ND(1)
Manufacturer Name : Hubei JXBio Pharmaceutical C...
Manufacturer Address : No. 9 Lvshan Road, Xian'an Economic Development Zone, Xianning City, Hubei Province, ...
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Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2025-03-04
Registration Number : 434-73-ND
Manufacturer Name : Hubei JXBio Pharmaceutical C...
Manufacturer Address : No. 9 Lvshan Road, Xian'an Economic Development Zone, Xianning City, Hubei Province, ...
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Fujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.
NDC Package Code : 84502-103
Start Marketing Date : 2024-07-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 76617-020
Start Marketing Date : 2022-12-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 14403-0017
Start Marketing Date : 2024-06-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84824-006
Start Marketing Date : 2025-01-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84196-102
Start Marketing Date : 2024-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 71052-167
Start Marketing Date : 2023-05-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
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NDC Package Code : 85673-226
Start Marketing Date : 2025-05-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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Product Web Link
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Digital Content
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NDC Package Code : 85512-1079
Start Marketing Date : 2025-06-02
End Marketing Date : 2026-12-31
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 : 84666-001
Start Marketing Date : 2024-08-22
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 : 16812-104
Start Marketing Date : 2024-10-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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 solutions, offering global API and preparation production services. Co-founded by...
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, employing advanced chemical strategies such as microwave-assisted solid-phase synthesis. T...
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...
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Details:
Mounjaro (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently it is indicated for the treatment of type 2 diabetes mellitus and obesity.
Lead Product(s): Tirzepatide
Therapeutic Area: Endocrinology Brand Name: Mounjaro
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Eli Lilly
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 20, 2024
Lead Product(s) : Tirzepatide
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eli Lilly
Deal Size : Inapplicable
Deal Type : Inapplicable
Aspen Announces Local Availability of Lilly’s Mounjaro
Details : Mounjaro (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently it is indicated for the treatment of type 2 diabetes mellitus and obesity.
Product Name : Mounjaro
Product Type : Peptide
Upfront Cash : Inapplicable
December 20, 2024
Details:
The net proceeds from the offering will be used to fund the developement of Vyleesi (bremelanotide acetate), which is being evaluated in mid-stage clinical trial studies for the treatment of obesity.
Lead Product(s): Bremelanotide Acetate,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Vyleesi
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Alliance Global Partners
Deal Size: $23.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 07, 2025
Lead Product(s) : Bremelanotide Acetate,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Alliance Global Partners
Deal Size : $23.0 million
Deal Type : Public Offering
Palatin Technologies Announces Pricing of up to $23 Million Public Offering
Details : The net proceeds from the offering will be used to fund the developement of Vyleesi (bremelanotide acetate), which is being evaluated in mid-stage clinical trial studies for the treatment of obesity.
Product Name : Vyleesi
Product Type : Peptide
Upfront Cash : Undisclosed
May 07, 2025
Details:
Vyleesi (bremelanotide) is a melanocortin receptor agonist (MCR), which is being evaluated in combination with tirzepatide for obesity.
Lead Product(s): Bremelanotide Acetate,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Vyleesi
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 17, 2025
Lead Product(s) : Bremelanotide Acetate,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Palatin Sees Positive Appetite Suppression in Obesity Study with Bremelanotide Combo
Details : Vyleesi (bremelanotide) is a melanocortin receptor agonist (MCR), which is being evaluated in combination with tirzepatide for obesity.
Product Name : Vyleesi
Product Type : Peptide
Upfront Cash : Inapplicable
April 17, 2025
Details:
Nimacimab is a first-in-class peripheral CB1-inhibiting antibody, being studied with the dual GLP-1/GIP agonist, tirzepatide for obesity.
Lead Product(s): Nimacimab,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 15, 2025
Lead Product(s) : Nimacimab,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Skye Shows 30% Weight Loss in Preclinical with Nimacimab Combo
Details : Nimacimab is a first-in-class peripheral CB1-inhibiting antibody, being studied with the dual GLP-1/GIP agonist, tirzepatide for obesity.
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
April 15, 2025
Details:
Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for obesity.
Lead Product(s): Bremelanotide Acetate,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Vyleesi
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2025
Lead Product(s) : Bremelanotide Acetate,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Palatin's MC4R Agonist Bremelanotide with GLP-1/GIP Tirzepatide Hits Ph 2 Goal
Details : Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for obesity.
Product Name : Vyleesi
Product Type : Peptide
Upfront Cash : Inapplicable
March 31, 2025
Details:
Mounjaro (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently it is indicated for the treatment of type 2 diabetes mellitus and obesity.
Lead Product(s): Tirzepatide
Therapeutic Area: Endocrinology Brand Name: Mounjaro
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 20, 2025
Lead Product(s) : Tirzepatide
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eli Lilly Launches Weight-Loss Drug Mounjaro in India After Drug Regulator Approval
Details : Mounjaro (tirzepatide) injection is an obesity treatment targeting GIP and GLP-1 hormone receptors. Currently it is indicated for the treatment of type 2 diabetes mellitus and obesity.
Product Name : Mounjaro
Product Type : Peptide
Upfront Cash : Inapplicable
March 20, 2025
Details:
ARO-INHBE is a RNAi-based candidate, is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E, being developed for obesity and metabolic diseases.
Lead Product(s): ARO-INHBE,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: ARO-INHBE
Study Phase: Phase I/ Phase IIProduct Type: Oligonucleotide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 06, 2025
Lead Product(s) : ARO-INHBE,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Arrowhead Showcases RNAi Candidates for Obesity, Metabolic Disorders
Details : ARO-INHBE is a RNAi-based candidate, is designed to reduce the hepatic expression of the INHBE gene and its secreted gene product, Activin E, being developed for obesity and metabolic diseases.
Product Name : ARO-INHBE
Product Type : Oligonucleotide
Upfront Cash : Inapplicable
March 06, 2025
Details:
Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for obesity.
Lead Product(s): Bremelanotide Acetate,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Brand Name: Vyleesi
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 06, 2025
Lead Product(s) : Bremelanotide Acetate,Tirzepatide
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Palatin Completes Phase 2 Obesity Study With MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide
Details : Vyleesi (bremelanotide) is a melanocortin receptor 4 agonist (MCR4), which is being evaluated in combination with tirzepatide for obesity.
Product Name : Vyleesi
Product Type : Peptide
Upfront Cash : Inapplicable
February 06, 2025
Details:
Zepbound (tirzepatide) injection is a first obstructive sleep apnea in adults with obesity treatment of its kind that activates both GIP/GLP-1 hormone receptors.
Lead Product(s): Tirzepatide
Therapeutic Area: Sleep Brand Name: Zepbound
Study Phase: Approved FDFProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 20, 2024
Lead Product(s) : Tirzepatide
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Zepbound® (Tirzepatide) for Obstructive Sleep Apnea in Adults with Obesity
Details : Zepbound (tirzepatide) injection is a first obstructive sleep apnea in adults with obesity treatment of its kind that activates both GIP/GLP-1 hormone receptors.
Product Name : Zepbound
Product Type : Peptide
Upfront Cash : Inapplicable
December 20, 2024
Details:
Oral DehydraTECH-technology processed tirzepatide (GLP-1 + GIP agonist) is being investigated for diabetes mellitus and obesity.
Lead Product(s): Tirzepatide
Therapeutic Area: Endocrinology Brand Name: DehydraTECH-tirzepatide
Study Phase: Phase IProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 19, 2024
Lead Product(s) : Tirzepatide
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lexaria's Registered GLP-1 Study #4 Begins Dosing
Details : Oral DehydraTECH-technology processed tirzepatide (GLP-1 + GIP agonist) is being investigated for diabetes mellitus and obesity.
Product Name : DehydraTECH-tirzepatide
Product Type : Peptide
Upfront Cash : Inapplicable
December 19, 2024
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,...
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
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
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
Regulatory Info : RX
Registration Country : USA
Brand Name : MOUNJARO
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 15MG/0.5ML (15MG/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 : 7.5MG/0.5ML (7.5MG/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
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 7.5MG/0.5ML (7.5MG/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 : 15MG/0.5ML (15MG/0.5ML)
Packaging :
Approval Date : 2024-03-28
Application Number : 217806
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541076
Regulatory Info :
Registration Country : Canada
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
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
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 : ZEPBOUND (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 2.5MG/0.5ML (2.5MG/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 : 5MG/0.5ML (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 : 7.5MG/0.5ML (7.5MG/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 : 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 :
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 :
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
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
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541068
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541076
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 10MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541084
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 12.5MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541092
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO
Dosage Form : SOLUTION
Dosage Strength : 15MG/0.5ML
Packaging :
Approval Date :
Application Number : 2541106
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 2.5MG/0.6ML
Packaging :
Approval Date :
Application Number : 2551950
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 7.5MG/0.6ML
Packaging :
Approval Date :
Application Number : 2551977
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 10MG/0.6ML
Packaging :
Approval Date :
Application Number : 2551985
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : MOUNJARO KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 12.5MG/0.6ML
Packaging :
Approval Date :
Application Number : 2551993
Regulatory Info :
Registration Country : Canada
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
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
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
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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