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Chemistry

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Also known as: Retatrutide api
Retatrutide (LY3437943) is a biologic entity that acts as a triagonist for the gastric inhibitory polypeptide (GIP) receptor, the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor. It is an investigational drug developed by Eli Lilly for obesity, type 2 diabetes, and related metabolic disorders.

API SUPPLIERS

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01

Fujian Genohope Biotech

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.

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Digital Content Digital Content
USDMF arrow-down Click Us! arrow-down
CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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02

Shanghai Minbiotech

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Shanghai Minbiotech CB

04

Omgene Life Sciences Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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05

Vtides Life Sciences Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

Hangzhou Taijia Biotechnology

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Hangzhou Taijia Biotechnology

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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07

Tian Yuan Pharm

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Tian Yuan Pharm

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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Jade Nutripharma

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Jade Nutripharma

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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09

Xiushi Biopharma

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Xiushi Biopharma

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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10

Protheragen

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
Not Confirmed
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Protheragen

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.

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Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 42392

Submission : 2025-08-28

Status : Active

Type : II

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02

Sichuan Jisheng Biopharmaceutical Co...

Country

USDMF

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BIO Partnering at JPM
Not Confirmed

02

Sichuan Jisheng Biopharmaceutical Co...

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BIO Partnering at JPM
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41577

Submission : 2025-03-19

Status : Active

Type : II

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFujian Genohope Biotech is a leading provider of high-potency peptide APIs, offering GMP quality and worldwide delivery.

Flag China
Digital Content Digital Content

Retatrutide

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...

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 Hope Hosencare Brothers and Taiwan Genovior Biotech Corporation, the company operates from the Cross-Strait Biotechnology and Health and Medical Industry Cooperation Zone in Fujian, China. With a 70,000-square-meter GMP-compliant facility and 11 production lines, it meets regulatory requirements for China, the U.S., and international markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

Flag China
Digital Content Digital Content

Retatrutide

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...

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 Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Shanghai Minbiotech CB

03

Retatrutide

About the Company : Our mission is to help make research possible by supplying scientists worldwide with the basic research tools necessary for advancing human and animal health. Our utmost commitment...

Our mission is to help make research possible by supplying scientists worldwide with the basic research tools necessary for advancing human and animal health. Our utmost commitment to healthcare researchers is to offer the highest quality products with an affordable pricing policy. Our scientists are experts in the synthesis, purification, and characterization of biochemicals ranging from small drug-like heterocycles to complex biolipids, fatty acids, and many others. We are also highly skilled in all aspects of assay and antibody development, protein expression, crystallization, and structure determination.
Cayman

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Retatrutide

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...

Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Omgene Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVtides Life Sciences: Pioneering Peptide API Development & Manufacturing in State-of-the-art GMP Facilities Since 2024.

Flag India
Digital Content Digital Content

Retatrutide

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...

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 company operates GMP-compliant facilities equipped with automated peptide synthesizers, preparative HPLC systems, lyophilizers, and advanced analytical instruments. Vtides applies science and technology to manufacture affordable Active Pharmaceutical Ingredients (APIs) that support the production of high-quality medicines for pharmaceutical companies. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Company Banner

06

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
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Retatrutide

About the Company : It is located in Tianhe hi tech park, Binjiang District, Hangzhou. The company's main researchers have more than ten years of experience in peptide product research and development...

It is located in Tianhe hi tech park, Binjiang District, Hangzhou. The company's main researchers have more than ten years of experience in peptide product research and development, and can provide you with peptide sequence design services and various special modified peptide production. At present, we can provide: glycopeptide, isotope labeled peptide, macrocyclic chelating peptide, MAPS compound antigen peptide, which can be used in various scientific research; various fluorescent labeled peptides, which can be used in enzyme activity determination and molecular probe research; click on chemical peptide
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07

BIO Partnering at JPM
Not Confirmed
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Retatrutide

About the Company : Jade Nutripharma is a global distributor of pharmaceutical, nutritional, cosmetic, animal nutrition, and agrochemical ingredients and equipment. Leveraging over 15 years of experie...

Jade Nutripharma is a global distributor of pharmaceutical, nutritional, cosmetic, animal nutrition, and agrochemical ingredients and equipment. Leveraging over 15 years of experience, we deliver differentiated products and tailor-made solutions backed by science, innovation, and deep regulatory expertise. With an international logistics network and high quality standards, we help clients accelerate project development through sourcing, formulation, and compliance. Based in Xiaoshan District, Hangzhou (Zhejiang, China), our qualified team ensures excellence in service and delivery worldwide.
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Protheragen

U.S.A
BIO Partnering at JPM
Not Confirmed
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Protheragen

U.S.A
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BIO Partnering at JPM
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Retatrutide

About the Company : Protheragen helps clients achieve cost-effective improvements in R&D productivity by providing reliable products and solutions to the global chemical industry. Our offerings includ...

Protheragen helps clients achieve cost-effective improvements in R&D productivity by providing reliable products and solutions to the global chemical industry. Our offerings include chemical products, packaging, equipment, and custom synthesis. With state-of-the-art manufacturing facilities, professional R\&D teams, and ISO9001 certification, we are committed to becoming a leading supplier of pharmaceutical ingredients and specialty chemicals, delivering quality and innovation to meet diverse industry needs worldwide.
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BIO Partnering at JPM
Not Confirmed
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Retatrutide

About the Company : Tianyuan Pharmaceutical Co., Ltd. specializes in the research and development of targeted anticancer drugs and is dedicated to the exploration, production, and promotion of medical...

Tianyuan Pharmaceutical Co., Ltd. specializes in the research and development of targeted anticancer drugs and is dedicated to the exploration, production, and promotion of medical raw materials. The company's primary product line includes Crizotinib, Afatinib, Capmatinib, Aloitinib, Sorafenib, Ibrutinib, Lenvatinib, Mirogabalin, Omarigliptin, Peficitinib, as well as various other types of TINI API and intermediates.Tianyuan has established stable collaboration with amplification plants in Jiaozhou, Qingdao, facilitating the scaling up of production from 100kg to tonnage quantities.
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BIO Partnering at JPM
Not Confirmed
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Retatrutide

About the Company : Xiushi Biopharma is a leading global CDMO specializing in peptide and oligonucleotide drug development and manufacturing. With a 5,000 sqm R&D center and 20,000 sqm GMP-compliant p...

Xiushi Biopharma is a leading global CDMO specializing in peptide and oligonucleotide drug development and manufacturing. With a 5,000 sqm R&D center and 20,000 sqm GMP-compliant production facility, we support clients from discovery to commercialization, offering scalable synthesis up to kg quantities. Our expertise spans peptide CMC development, NCEs, and generic drug manufacturing, ensuring compliance with FDA/EU GMP standards. Backed by a skilled scientific team, we deliver end-to-end solutions for peptide-based therapeutics, accelerating biopharma innovation worldwide.
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DATA COMPILATION #PharmaFlow

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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 2938

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

#PharmaFlow by PHARMACOMPASS
13 Nov 2025

NEWS #PharmaBuzz

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