Please Wait
Applying Filters...
menu
    • menu
    Granules India-PSE
    News
    Granules India appoints Ovais Sarmad as sustainability advisor

    18 Nov 2024

    // EXPRESSPHARMA

    Granules India presented with Golden Peacock Award for sustainability

    15 Nov 2024

    // EXPRESSPHARMA

    Granules India Q2 FY25 PAT drops 5% YoY to Rs. 97 Cr

    06 Nov 2024

    // PRESS RELEASE

    Data Compilation
    #PharmaFlow

    Granules India

    Contact Supplier

    Website

    CPhI India 2024

    Attending

    Book a meeting

    envelop Contact Supplier

    Latest Content by PharmaCompass

    radio-compass-blog/medical-breakthroughs-in-2024-alzheimer-s-schizophrenia-copd-mash-see-pathbreaking-treatments
    Menu

    Granules India Limited

    EVENTS

    • Webinars & Exhibitions

    PRESENTATION(s)

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    Key Products KEY PRODUCTS

    INSPECTIONS & REGISTRATIONS

    PharmaCompass

    Filters

    clear-filterReset all filters
    Left Arrow
    Right Arrow

    Digital content

    Explore the latest content creation from this company

    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-4179.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    Corporate Presentation

    read-more

      https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-37474.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    API Product List 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-72189.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    FDF Product List 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-59178.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    PFI Product List 2024

    read-more

      https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-89567.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    GMP Certificate 2020

    read-more

      https://www.pharmacompass.com/pdf/party/content/granules-india-limited-party-content-93959.pdf

      Open PDFOpen PDF
      UploadUpload
      Key ShareShare

    DATA COMPILATION #PharmaFlow

    read-more
    read-more
    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.   
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 6152

    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
    Share Share

    NEWS #PharmaBuzz

    read-more
    read-more
    Granules India appoints Ovais Sarmad as sustainability advisor
    Granules India appoints Ovais Sarmad as sustainability advisor

    18 Nov 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/granules-india-appoints-ovais-sarmad-as-sustainability-advisor/

    EXPRESSPHARMA
    18 Nov 2024
    Share Share
    Granules India presented with Golden Peacock Award for sustainability
    Granules India presented with Golden Peacock Award for sustainability

    15 Nov 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/granules-india-presented-with-the-golden-peacock-award-for-sustainability/

    EXPRESSPHARMA
    15 Nov 2024
    Share Share
    Granules India Q2 FY25 PAT drops 5% YoY to Rs. 97 Cr
    Granules India Q2 FY25 PAT drops 5% YoY to Rs. 97 Cr

    06 Nov 2024

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2024/11/Press-Release-Q2.pdf

    PRESS RELEASE
    06 Nov 2024
    Share Share
    Granules India gets USFDA nod for generic Glycopyrrolate oral solution
    Granules India gets USFDA nod for generic Glycopyrrolate oral solution

    20 Aug 2024

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2024/08/ANDA-Approval-for-Glycopyrrolate-Oral-Solution.pdf

    PRESS RELEASE
    20 Aug 2024
    Share Share
    Granules India gains ANDA approval for Trazodone tablets
    Granules India gains ANDA approval for Trazodone tablets

    09 Aug 2024

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2024/08/Trazodone-Tabs-approval-PR.pdf

    PRESS RELEASE
    09 Aug 2024
    Share Share
    Granules India's Q1 profit nearly triples on strong demand
    Granules India's Q1 profit nearly triples on strong demand

    30 Jul 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/granules-indias-q1-profit-nearly-triples-strong-demand-2024-07-30/

    REUTERS
    30 Jul 2024
    Share Share
    Contact Granules India Limited and get a quotation

    Granules India Limited is a supplier offers 51 products (APIs, Excipients or Intermediates).

    Find a price of Metformin bulk with DMF, CEP, JDMF, WC offered by Granules India Limited

    Find a price of Paracetamol bulk with DMF, CEP, JDMF, WC offered by Granules India Limited

    Find a price of Atazanavir Sulfate bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Cetirizine Dihydrochloride bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Guaifenesin bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Losartan Potassium bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Metformin bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Metoprolol Succinate bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Pirfenidone bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Rifaximin bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Trazodone Hydrochloride bulk with DMF, CEP, WC offered by Granules India Limited

    Find a price of Dimethyl Fumarate bulk with DMF, WC offered by Granules India Limited

    Find a price of Eltrombopag bulk with DMF, WC offered by Granules India Limited

    Find a price of Esomeprazole Magnesium bulk with DMF, CEP offered by Granules India Limited

    Find a price of Fexofenadine Hydrochloride bulk with DMF, WC offered by Granules India Limited

    Find a price of Guaifenesin bulk with DMF, CEP offered by Granules India Limited

    Find a price of Levetiracetam bulk with DMF, CEP offered by Granules India Limited

    Find a price of Levocetirizine Dihydrochloride bulk with DMF, WC offered by Granules India Limited

    Find a price of Metformin bulk with CEP, WC offered by Granules India Limited

    Find a price of Methocarbamol bulk with DMF, WC offered by Granules India Limited

    Find a price of Omeprazole bulk with DMF, CEP offered by Granules India Limited

    Find a price of Omeprazole Magnesium bulk with DMF, WC offered by Granules India Limited

    Find a price of Pantoprazole Sodium bulk with DMF, CEP offered by Granules India Limited

    Find a price of Rifaximin bulk with DMF, CEP offered by Granules India Limited

    Find a price of Bupropion Hydrochloride bulk with DMF offered by Granules India Limited

    Find a price of Capecitabine bulk with CEP offered by Granules India Limited

    Find a price of Dapagliflozin bulk with DMF offered by Granules India Limited

    Find a price of Dasatinib bulk with DMF offered by Granules India Limited

    Find a price of Empagliflozin bulk with DMF offered by Granules India Limited

    Find a price of Esomeprazole Magnesium bulk with DMF offered by Granules India Limited

    Find a price of Gabapentin bulk with WC offered by Granules India Limited

    Find a price of Gliclazide bulk with CEP offered by Granules India Limited

    Find a price of Lapatinib Ditosylate bulk with DMF offered by Granules India Limited

    Find a price of Linagliptin bulk with DMF offered by Granules India Limited

    Find a price of Losartan Potassium bulk with DMF offered by Granules India Limited

    Find a price of Metoprolol Succinate bulk with DMF offered by Granules India Limited

    Find a price of Nilotinib bulk with DMF offered by Granules India Limited

    Find a price of Paracetamol bulk with DMF offered by Granules India Limited

    Find a price of Pazopanib Hydrochloride bulk with DMF offered by Granules India Limited

    Find a price of Penicillamine bulk with CEP offered by Granules India Limited

    Find a price of Prazosin Hydrochloride bulk with DMF offered by Granules India Limited

    Find a price of Sorafenib bulk with DMF offered by Granules India Limited

    Find a price of Tenofovir Disoproxil Succinate bulk with WC offered by Granules India Limited

    Find a price of Vigabatrin bulk with DMF offered by Granules India Limited

    Find a price of Viloxazine Hydrochloride bulk with DMF offered by Granules India Limited

    Find a price of Avatrombopag Maleate bulk offered by Granules India Limited

    Find a price of Cabozantinib bulk offered by Granules India Limited

    Find a price of Elacestrant bulk offered by Granules India Limited

    Find a price of Ruxolitinib Phosphate bulk offered by Granules India Limited

    Find a price of Sitagliptin Phosphate bulk offered by Granules India Limited

    Find a price of Tenofovir Alafenamide Fumarate bulk offered by Granules India Limited