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    Maithri Drugs is one of India's fastest growing pharmaceutical companies, strategically focused on Active Pharmaceutical Ingredients (APIs). Backed by a strong R&D foundation, we hold over 150 Drug Master Files (DMFs) globally, including 54 US DMFs and 16 Certificates of Suitability (CEPs). Our state-of-the-art manufacturing facility in Hyderabad is approved by the US FDA and certified by DGCI, WHO GMP, and ISO 9001:2015. With a portfolio of over 65 APIs across therapeutic areas such as CNS, cardiovascular, anti-infectives, and anti-diabetics, we export to more than 35 countries, driven by quality, innovation, and long-term client trust.

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    GMP Certificate 2024

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    DATA COMPILATION #PharmaFlow

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

    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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    01

    Brimonidine Tartrate

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36595

    Submission : 2021-12-09

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2021-507 - Rev 00

    Issue Date : 2023-07-04

    Type : Chemical

    Substance Number : 2760

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

    Written Confirmation Number : WC-0407

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    02

    Carbidopa

    India

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35521

    Submission : 2020-12-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-143 - Rev 00

    Issue Date : 2021-06-11

    Type : Chemical

    Substance Number : 755

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

    Written Confirmation Number : WC-0407

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    03

    Carbimazole

    India

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    DMF Review : N/A

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    Pay. Date :

    DMF Number : 35808

    Submission : 2021-03-29

    Status : Active

    Type : II

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    Certificate Number : CEP 2018-103 - Rev 02

    Issue Date : 2024-06-05

    Type : Chemical

    Substance Number : 884

    Status : Valid

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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

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    04

    Foscarnet Sodium

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    DMF Review : N/A

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    DMF Number : 34968

    Submission : 2020-07-04

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-218 - Rev 00

    Issue Date : 2022-05-19

    Type : Chemical

    Substance Number : 1520

    Status : Valid

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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

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    05

    Ketamine Hydrochloride

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    DMF Review : N/A

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    DMF Number : 37014

    Submission : 2022-03-29

    Status : Active

    Type : II

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    Certificate Number : CEP 2022-157 - Rev 00

    Issue Date : 2024-03-04

    Type : Chemical

    Substance Number : 1020

    Status : Valid

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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

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    Mesalazine

    India

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    DMF Review : N/A

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    Pay. Date :

    DMF Number : 31570

    Submission : 2017-03-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2017-116 - Rev 00

    Issue Date : 2023-04-13

    Type : Chemical

    Substance Number : 1699

    Status : Valid

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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

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    Methimazole

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    DMF Review : Reviewed

    Rev. Date : 2023-03-21

    Pay. Date : 2023-01-31

    DMF Number : 36643

    Submission : 2021-12-29

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-029 - Rev 02

    Issue Date : 2025-06-25

    Type : Chemical

    Substance Number : 1706

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

    Written Confirmation Number : WC-0407

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    08

    Mirtazapine

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-12-13

    Pay. Date : 2024-11-22

    DMF Number : 31322

    Submission : 2017-01-19

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2018-225 - Rev 01

    Issue Date : 2024-04-10

    Type : Chemical

    Substance Number : 2338

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

    Written Confirmation Number : WC-0407

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    09

    Nitrofurantoin

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-09-08

    Pay. Date : 2022-07-27

    DMF Number : 33877

    Submission : 2019-05-31

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2019-262 - Rev 01

    Issue Date : 2024-05-02

    Type : Chemical

    Substance Number : 101

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

    Written Confirmation Number : WC-0407

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    10

    Nitrofurantoin

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34179

    Submission : 2019-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2022-074 - Rev 00

    Issue Date : 2022-12-12

    Type : Chemical

    Substance Number : 101

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2024-02-12

    Valid Till : 2027-02-11

    Written Confirmation Number : WC-0407

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    01

    Abrocitinib

    India
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    Maithri Drugs

    GDUFA

    DMF Review : N/A

    Rev. Date :

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    DMF Number : 41402

    Submission : 2025-02-28

    Status : Active

    Type : II

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    02

    Adapalene Usp

    India
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    GDUFA

    DMF Review : N/A

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    DMF Number : 39063

    Submission : 2023-10-21

    Status : Active

    Type : II

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    03

    Avacopan

    India
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2025-06-25

    Pay. Date : 2025-05-20

    DMF Number : 40159

    Submission : 2024-06-29

    Status : Active

    Type : II

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    04

    Besifloxacin Hydrochloride

    India
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    GDUFA

    DMF Review : N/A

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    DMF Number : 35809

    Submission : 2021-03-29

    Status : Active

    Type : II

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    05

    Brimonidine Tartrate Usp

    India
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    GDUFA

    DMF Review : N/A

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    DMF Number : 36595

    Submission : 2021-12-09

    Status : Active

    Type : II

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    06

    Carbidopa Usp

    India
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35521

    Submission : 2020-12-31

    Status : Active

    Type : II

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    07

    Carbimazole

    India
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    Maithri Drugs

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35808

    Submission : 2021-03-29

    Status : Active

    Type : II

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    08

    Chlorthalidone Usp

    India
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    Maithri Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-10-09

    Pay. Date : 2018-08-03

    DMF Number : 32641

    Submission : 2018-03-30

    Status : Active

    Type : II

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    09

    Dapoxetine Hydrochloride

    India
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    Booth #12.0D69
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    Maithri Drugs

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34632

    Submission : 2020-02-28

    Status : Active

    Type : II

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    10

    Deutetrabenazine

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Maithri Drugs

    GDUFA

    DMF Review : Complete

    Rev. Date : 2025-05-28

    Pay. Date : 2025-05-20

    DMF Number : 35158

    Submission : 2020-08-31

    Status : Active

    Type : II

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    CEP/COS

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    01

    Brimonidine tartrate

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
    • fda
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    Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

    Maithri Drugs

    Certificate Numbers : R0-CEP 2021-507 - Rev 00

    Status : Valid

    Issue Date : 2023-07-04

    Type : Chemical

    Substance Number : 2760

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    02

    Carbidopa

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Maithri Drugs

    Certificate Numbers : R0-CEP 2020-143 - Rev 00

    Status : Valid

    Issue Date : 2021-06-11

    Type : Chemical

    Substance Number : 755

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    03

    Carbimazole

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Maithri Drugs

    Certificate Numbers : CEP 2018-103 - Rev 02

    Status : Valid

    Issue Date : 2024-06-05

    Type : Chemical

    Substance Number : 884

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    04

    Esketamine hydrochloride

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Maithri Drugs

    Certificate Numbers : CEP 2022-319 - Rev 00

    Status : Valid

    Issue Date : 2024-05-03

    Type : Chemical

    Substance Number : 1742

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    05

    Foscarnet sodium hexahydrate

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

    Maithri Drugs

    Certificate Numbers : R0-CEP 2020-218 - Rev 00

    Status : Valid

    Issue Date : 2022-05-19

    Type : Chemical

    Substance Number : 1520

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    06

    Ketamine hydrochloride

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

    Maithri Drugs

    Certificate Numbers : CEP 2022-157 - Rev 00

    Status : Valid

    Issue Date : 2024-03-04

    Type : Chemical

    Substance Number : 1020

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    07

    Levodopa

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

    Maithri Drugs

    Certificate Numbers : R0-CEP 2020-161 - Rev 00

    Status : Valid

    Issue Date : 2022-03-14

    Type : Chemical

    Substance Number : 38

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    08

    Mesalazine

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

    Maithri Drugs

    Certificate Numbers : R1-CEP 2017-116 - Rev 00

    Status : Valid

    Issue Date : 2023-04-13

    Type : Chemical

    Substance Number : 1699

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    09

    Mirtazapine

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
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    Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

    Maithri Drugs

    Certificate Numbers : CEP 2017-010 - Rev 01

    Status : Valid

    Issue Date : 2024-06-17

    Type : Chemical

    Substance Number : 2338

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    10

    Mirtazapine, Route code "ZA"

    India
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    CPhI WW Frankfurt
    Booth #12.0D69
    • fda
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    Virtual BoothMaithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.

    Maithri Drugs

    Certificate Numbers : CEP 2018-225 - Rev 01

    Status : Valid

    Issue Date : 2024-04-10

    Type : Chemical

    Substance Number : 2338

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    KEY PRODUCTS

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    Contact Maithri Drugs and get a quotation

    Maithri Drugs is a supplier offers 136 products (APIs, Excipients or Intermediates).

    Find a price of Brimonidine Tartrate bulk with DMF, CEP, WC offered by Maithri Drugs

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