BLOG
MARKET INTEL by PharmaCompass
CONTENT by Suppliers
- Interview #SpeakPharma
- Video #SupplierSpotlight
- Vlog #PharmaReel
- Company Bio #AboutSupplier
- Services Bio #AboutCapabilities
News
Create content with us, ask us
By PharmaCompass
2025-11-13
Impressions: 259
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 products
A 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
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 follow
China’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 & tucatinib
Dr. 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 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 view
For 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.
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : FDA DMF filings in Q3 2025 by PharmaCompass license under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
