Granules India Limited DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News

Corporate Presentation

API Product List 2025

FDF Product List 2025

Click the button for full data set

PFI Product List 2025

GMP Certificate 2020

DATA COMPILATION #PharmaFlow

DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024. Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each. The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders). View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2025: The FDA’s 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. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453 US$ 3,21,920 Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427 US$ 2,31,952 FDF—Foreign US$ 2,35,427 US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629 US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852 US$ 7,56,666 Small business generic drug applicant US$ 1,72,963 US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.

Impressions: 6992

NEWS #PharmaBuzz

Granules India Receives FDA Warning Letter

04 Mar 2025

// FDA

Granules India acquires Senn Chemical to foray into peptide & CDMO

22 Feb 2025

// INDPHARMAPOST

Granules Strengthens ADHD Portfolio with FDA Approval

30 Jan 2025

// PRESS RELEASE

Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr

27 Jan 2025

// PRESS RELEASE

Nomura Upgrade Lifts Dr Reddy's Share Over 4%

29 Dec 2024

// BUSINESS STD

Granules India gets USFDA nod for ADHD Treatment

17 Dec 2024

// PRESS RELEASE

ALL APIs

01

Metformin

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

Click Us!

CEP/COS

JDMF

EU-WC

NDC

KDMF

VMF ASMF, CA...

AUDIT

02

Paracetamol

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF

EU-WC

NDC

KDMF

VMF ASMF, CA...

AUDIT

03

Atazanavir Sulfate

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF MX, ASMF

AUDIT

04

Cetirizine Dihydrochloride

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF CN, ASMF

AUDIT

05

Guaifenesin

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF BR, ASMF

AUDIT

06

Guaifenesin

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF BR, ASMF

AUDIT

07

Losartan Potassium

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF CN

AUDIT

08

Metformin

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF

VMF ASMF, CA...

AUDIT

09

Metoprolol Succinate

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF ASMF

AUDIT

10

Pirfenidone

India

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

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

USDMF

CEP/COS

JDMF EU-WC

NDC

KDMF VMF ASMF, CN

AUDIT

Only 10 entries up to this point, click to access all

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

USDMF

01

Acetaminophen Usp

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-08

Pay. Date : 2012-11-29

DMF Number : 19804

Submission : 2006-09-28

Status : Active

Type : II

02

Atazanavir Sulfate

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32259

Submission : 2017-12-27

Status : Active

Type : II

03

Bupropion Hydrochloride Usp

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2021-05-27

Pay. Date : 2021-04-15

DMF Number : 35694

Submission : 2021-03-29

Status : Active

Type : II

04

Cetirizine Hydrochloride, Usp

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2016-03-23

Pay. Date : 2015-12-14

DMF Number : 30063

Submission : 2016-02-01

Status : Active

Type : II

05

Compresso Ggf 95 Sa (guaifenesin Gra...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20998

Submission : 2007-10-31

Status : Active

Type : II

06

Compresso Ibu 66s

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20606

Submission : 2007-06-12

Status : Active

Type : II

07

Compresso Ibu 85 Par (ibuprofen Gran...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35886

Submission : 2021-05-18

Status : Active

Type : II

08

Compresso Lsp 33.333 % (losartan Pot...

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36088

Submission : 2021-07-12

Status : Active

Type : II

09

Compresso Mf 95p

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17723

Submission : 2004-09-22

Status : Active

Type : II

10

Compresso Pap 90 Cpc

India

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19972

Submission : 2006-11-16

Status : Active

Type : II