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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.
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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Registrant Name : Korea Lily Co., Ltd.
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 : Korea Lily Co., Ltd.
Registration Date : 2025-10-15
Registration Number : Su253-12-ND
Manufacturer Name : Eli Lilly and Company@Eli Li...
Manufacturer Address : Indianapolis, Indiana 46285, USA@Dunderrow, Kinsale, P17 NY71, Ireland

Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-04-17
Registration Number : Su6199-4-ND
Manufacturer Name : Hybio Pharmaceutical (Wuhan)...
Manufacturer Address : No. 9 Linkong West Street, Hengdian Street, Huangpi District, Wuhan City, Hubei 43030...

Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2025-03-04
Registration Number : Su434-73-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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Registrant Name : Korea Lily Co., Ltd.
Registration Date : 2025-10-20
Registration Number : Su253-13-ND
Manufacturer Name : Taixing Syntheall Pharmaceut...
Manufacturer Address : 18 Tianxing Road, Jiangsu Taixing Economic Development Zone, Taixing, Jiangsu, 225442...

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Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2025-05-19
Registration Number : Su434-73-ND(A)
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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Website
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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...
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 specialize in offering a complete range of pharmaceutical peptide CDMO services alon...
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...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
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