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DMF Submitted for Lisdexamfetamine Dimesylate API

Small Volume Manufacture of APIs 2020

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Reference Standards List 2020

GMP Certificate 2018

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DATA COMPILATION #PharmaFlow

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.

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NEWS #PharmaBuzz

The Security of Onshore Manufacturing

03 Jul 2025

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The Noramco Invests $25M into Halo Pharma Facility in NJ

10 Mar 2025

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Diversifying the Supply of Raw Materials

12 Jun 2024

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Noramco Aligns with Purisys and Halo Pharma to Create Noramco Group

15 Mar 2024

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Noramco Announces the Acquisition of the Cambrex Drug Product Business Unit

02 Nov 2023

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Noramco Announces Submission & Reactivation of the Drug Master File for Active Pharmaceutical Ingredient Methylnaltrexone Bromide

01 Nov 2022

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ALL APIs

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

USDMF

01

Buprenorphine

U.S.A

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

Noramco

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-03

Pay. Date : 2016-09-08

DMF Number : 30762

Submission : 2016-08-04

Status : Active

Type : II

02

Buprenorphine Base (r371605) Drug Su...

U.S.A

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

Noramco

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-15

Pay. Date : 2012-11-23

DMF Number : 23684

Submission : 2010-04-05

Status : Active

Type : II

03

Buprenorphine Hydrochloride (r036869...

U.S.A

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

Noramco

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-23

Pay. Date : 2012-11-23

DMF Number : 23683

Submission : 2010-04-05

Status : Active

Type : II

04

Buprenorphine Hydrochloride, Usp

U.S.A

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

Noramco

GDUFA

DMF Review : Complete

Rev. Date : 2019-06-04

Pay. Date : 2016-09-08

DMF Number : 29885

Submission : 2016-08-16

Status : Active

Type : II

05

Cannabidiol Drug Substance

U.S.A

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GDUFA

DMF Review : Complete

Rev. Date : 2022-03-15

Pay. Date : 2022-03-10

DMF Number : 33223

Submission : 2019-02-22

Status : Active

Type : II

Product
Web Link

06

Codeine Phosphate

U.S.A

Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

Noramco

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-16

Pay. Date : 2012-11-23

DMF Number : 25856

Submission : 2012-03-30

Status : Active

Type : II

07

Dexmethylphenidate Hydrochloride

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2016-09-19

Pay. Date : 2015-09-15

DMF Number : 29411

Submission : 2016-05-27

Status : Active

Type : II

Product
Web Link

08

Dronabinol Drug Substance

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36220

Submission : 2021-10-12

Status : Active

Type : II

Product
Web Link

09

Dronabinol Drug Substance In Sesame ...

U.S.A

GDUFA

DMF Review : Complete

Rev. Date : 2022-06-28

Pay. Date : 2022-06-23

DMF Number : 20682

Submission : 2007-07-16

Status : Active

Type : II

Product
Web Link

10

Dronabinol, 10% In Sesame Oil

U.S.A

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19335

Submission : 2006-04-07

Status : Active

Type : II

Product
Web Link