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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.

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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

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CEP/COS

JDMF

EU-WC

NDC

KDMF

VMF ASMF, BR...

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 ASMF, MX

AUDIT

04

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 ASMF, BR

AUDIT

05

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 ASMF, CN

AUDIT

06

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, BR...

AUDIT

07

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

08

Rifaximin

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

09

Trazodone Hydrochloride

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

10

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 ASMF, BR

AUDIT

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USDMF

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JDMF

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EU WC

01

Atazanavir Sulphate IH/EP

India

India

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

Granules India Limited

Date of Issue : 2022-06-30

Valid Till : 2025-07-02

Written Confirmation Number : WC-0028n

Address of the Firm : 15A/1, IDA, Phase-III, Jeedime...

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Drugs in Development

01 Granules India Limited

India

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

Lead Product(s) : Trazodone Hydrochloride

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Gains ANDA approval for Trazodone Tablets

Details : Desyrel-Generic (trazodone hydrochloride) is a selective serotonin reuptake inhibitor indicated for the treatment of patients with major depressive disorder.

Product Name : Desyrel-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 08, 2024

02 Granules India Limited

India

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

Lead Product(s) : Glycopyrronium Bromide

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution

Details : Cuvposa is an anticholinergic indicated to reduce chronic severe drooling in patients aged 3-16 years with neurologic conditions associated with problem drooling.

Product Name : Cuvposa-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 20, 2024

03 Granules India Limited

India

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

Lead Product(s) : Pantoprazole Sodium

Therapeutic Area : Gastroenterology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Pantoprazole Sod Delayed-Release Tablets

Details : Pantoprazole Sodium Delayed-Release tablets are indicated for short-term treatment of Erosive Esophagitis Associated with GERD and Pathological Hypersecretory Conditions.

Product Name : Protonix-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 13, 2023

04 Granules India Limited

India

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

Lead Product(s) : Esomeprazole Magnesium

Therapeutic Area : Gastroenterology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Gets USFDA Nod for Generic Drug Used for Short-term Treatment of Heartburn

Details : Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor indicated for the treatment of gastroesophageal reflux disease and NSAID-associated gastric ulcer.

Product Name : Nexium-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 19, 2023

05 Granules India Limited

India

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

Lead Product(s) : Losartan Potassium,Hydrochlorothiazide

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Losartan and Hydrochlorothiazide Tablets

Details : Generic of Losartan potassium and hydrochlorothiazide tablets are been approved by FDA, indicated for hypertension to lower blood pressure and to reduce the risk of stroke.

Product Name : Cozaar-Generic

Product Type : Hormone

Upfront Cash : Inapplicable

September 30, 2023

06 Granules India Limited

India

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

Lead Product(s) : Ibuprofen

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

FDA Approves Granules' OTC Equivalent Of Advil Dual Action Tablets

Details : The company has received approval from the US Food and Drug Administration (USFDA) for generic version for Acetaminophen and Ibuprofen tablets (250 mg/125 mg) indicated for pain and inflammation.

Product Name : Advil-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 14, 2023

07 Granules India Limited

India

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

Lead Product(s) : Levetiracetam

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Receives ANDA Approval for Levetiracetam Tablets in record 9 months

Details : FDA approved generic of Levetiracetam for seizures. It prevents seizure activity via selective inhibition of hypersynchronized epileptiform burst firing without affecting normal neuronal transmission.

Product Name : Keppra-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 14, 2023

08 Granules India Limited

India

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

Lead Product(s) : Metoprolol Succinate

Therapeutic Area : Cardiology/Vascular Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Metoprolol Succinate ER Tablets

Details : Generic version of Metoprolol Succinate ER Tablets have been approved, these are catecholamines inhibitor indicated for the treatment of hypertension in order to lower blood pressure.

Product Name : Toprol-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 13, 2023

09 Granules India Limited

India

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

Lead Product(s) : Venlafaxine Hydrochloride

Therapeutic Area : Psychiatry/Psychology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Venlafaxine ER Capsules

Details : Generic version of Venlafaxine HCl extended-release capsules has been approved which are indicated for the treatment of MDD, GAD, SAD and Panic Disorder (PD).

Product Name : Effexor-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 19, 2023

10 Granules India Limited

India

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

Lead Product(s) : Gabapentin

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Granules India Limited Received ANDA Approval for Gabapentin Tablets

Details : Gabapentin inhibits the action of alpha-2-delta-1 subunits, thus decreasing the density of pre-synaptic voltage-gated calcium channels and subsequent release of excitatory neurotransmitters. It is indicated for the management of postherpetic neuralgia.

Product Name : Neurontin-Generic

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 29, 2023