Type II US DMF Analysis – Q2 2025
In the dashboard, we have provided an overview of the Type II Drug Master File (DMF) submission for Q2 2025. The focus of the dashboard is on the API-related filings across companies, products, and regions around globe. Here you will know the active regulatory engagement and the continued expansion in the API manufacturing capabilities.
Overall Snapshot
Total Type II DMFs - 278
Participating Companies – 180
Products – 250
Countries – 17
The wide spread of filings across numerous companies and products underscores consistent global participation in the US regulatory pathway for APIs.
Product Insights
Products with the highest DMF submissions include:
Semaglutide has the maximum amount of DMFs i.e. 4
Abemaciclib, Apixaban and Orforglipron have 3 DMFs each.
A lot of products such as Avacopan, Belumosudil Mesylate, Dapagliflozin Propanediol, Linagliptin, Olaparib, Sitagliptin Phosphate Monohydrate, Ticagrelor, and others have 2 DMFs.
The clustering around metabolic, oncology, and cardiovascular therapies reflects manufacturers’ focus on commercially relevant and high-demand molecules.
Leading Filing Companies
6 DMFs: Mubychem Pvt. Ltd., Zhejiang Ausun Pharmaceutical Co. Ltd.
4 DMFs: Allsino Pharmaceutical Co. Ltd., Apicore LLC, Hangzhou Cobetter Filtration Equipment Co. Ltd., Hetero Labs Ltd., Maithri Drugs Pvt. Ltd., Sichuan Kelun Pharmaceutical Co. Ltd., Yifan Pharmaceutical Shanghai Co. Ltd.
3 DMFs each: A broad group including Avanti Polar Lipids Inc., Cellupro Ltd., Chongqing Huapont Shengchem Pharm Co. Ltd., Emnar Pharma Pvt. Ltd., Honour Lab Ltd., Lee Pharma Ltd., Micro Labs Ltd., Shanghai Haoyuan Chemexpress Co. Ltd., SMS Pharmaceuticals Ltd., and others.
The distribution indicates a mix of established and emerging API manufacturers actively strengthening their US regulatory presence.
DMF Count by Country
China: 142 DMFs (56%)
India: 91 DMFs (36%)
United States: 19 DMFs (8%)
China and India collectively contribute 92% of all Type II filings, underscoring their dominant position in global API production and US market supply.
Key Observations
The Q2 2025 Type II DMF landscape reflects strong filing activity, led by Asian manufacturers with deep API portfolios and consistent regulatory engagement. High-interest therapeutic areas—particularly diabetes, oncology, and cardiovascular diseases—continue to receive the most submissions.
The balanced distribution across 180 companies shows active competition and strategic positioning for upcoming commercial opportunities. Overall, the data signals a robust and globally diversified API ecosystem, with clear leadership from China and India driving USDMF growth for this quarter.
Type IV US DMF Analysis – Q2 2025
This dashboard provides an overview of Type IV Drug Master File (DMF) submissions for Q2 2025, focusing on excipients and inactive pharmaceutical ingredients. The data highlights filing concentration across key products, leading manufacturers, and dominant geographies.
Overall Snapshot
Total Type IV DMFs – 82
Companies Involved – 30
Products – 74
Countries – 5
The spread of filings across numerous excipient categories indicates steady regulatory activity and supplier readiness for U.S. market requirements.
Product Insights
Products with the highest DMF submissions include:
Sodium Saccharin – 3 DMFs
Carbonic Acid Potassium Salt, Citric Acid, Empty Capsules, Hydroxypropyl Methyl Cellulose, Sodium Lauryl Sulfate, Zinc Undecylenate – 2 DMFs each
These filings reflect continued demand for widely used excipients in formulations such as tablets, capsules, oral liquids, and topical preparations.
Leading Filing Companies
Anmol Chemicals Pvt. Ltd. – 26 DMFs
Mubychem Pvt. Ltd. – 21 DMFs
Alcedo Pharmachem Pvt. Ltd. – 4 DMFs
A small group of Indian excipient manufacturers dominate the filing landscape, demonstrating strong regulatory participation and an extensive U.S.-focused portfolio.
DMF Count by Country
India: 57 DMFs (71%)
China: 19 DMFs (24%)
United States: 4 DMFs (5%)
India continues to be the primary contributor for Type IV DMFs, reaffirming its leadership in global excipient production and compliance maturity.
Industry Perspective
Q2 2025 Type IV DMF activity shows a highly concentrated market, with Indian manufacturers contributing the majority of excipient filings. Products with broad pharmaceutical utility, such as sodium saccharin, citric acid, and key polymeric excipients—form the core of submissions.
With a small set of companies driving most DMFs and strong representation from India and China, the data reflects a steady and well-established supply base for excipients entering the U.S. market.