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    Company profile for Granules India Limited

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    Granules India Q4FY26 revenue jumps 23% to Rs 14,706 million

    29 Apr 2026

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    Granules Life receives VAI Classification for Shamirpet facility

    01 Apr 2026

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    Granules India’s US packaging facility Passes FDA Inspection

    06 Mar 2026

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

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    About

    Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value chain- APIs, Formulation Intermediates, & Formulations. With 11 facilities (8 in India, 2 in the US and 1 in Europe) approved by US FDA, EDQM, EU GMP, WHO GMP, & more, its products reach 300+ customers in 80+ countries. Granules has offices in India, the US, & Europe ensuring a strong global presence.

    Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.

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    Granules India Limitedindia-flag Flag
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    15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500...
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    VLOG #PharmaReel

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    ReelPharmaAn Illustrious Journey of More Than 4 DecadesAn Illustrious Journey of More Than 4 Decades

    An Illustrious Journey of More Than 4 Decades
    An Illustrious Journey of More Than 4 Decades

    reelAn Illustrious Journey of More Than 4 Decades

    This PharmaReel showcases Granules India, manufacturing generic & high-potent APIs, PFIs & FDFs, and complex MUPS, supported by high volume world-class facilities and approvals from US FDA, EDQM, PMDA and ANVISA, serving 300+ customers in over 80 countries.

    Impressions: 1830

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2026

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    API Product List 2026

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    FDF Product List 2026

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    PFI Product List 2026

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    GMP Certificate 2025

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    DATA COMPILATION #PharmaFlow

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    DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions

    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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    #PharmaFlow by PHARMACOMPASS
    13 Nov 2025
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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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    Impressions: 10440

    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
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    NEWS #PharmaBuzz

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    Granules India Q4FY26 revenue jumps 23% to Rs 14,706 million
    Granules India Q4FY26 revenue jumps 23% to Rs 14,706 million

    29 Apr 2026

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/granules-india-q4fy26-revenue-jumps-23-to-rs-14706-million-fy26-revenue-at-rs-53656-million-19981

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    29 Apr 2026
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    Granules Life receives VAI Classification for Shamirpet facility
    Granules Life receives VAI Classification for Shamirpet facility

    01 Apr 2026

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2026/03/Granules-Life-Sciences-Receives-VAI-Classification-following-US-FDA-Inspection.pdf

    PRESS RELEASE
    01 Apr 2026
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    Granules India’s US packaging facility Passes FDA Inspection
    Granules India’s US packaging facility Passes FDA Inspection

    06 Mar 2026

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2026/03/Granules-Indias-Packaging-Facility-in-US-gets-FDA-EIR-with-No-Action-Indicated-Status.pdf

    PRESS RELEASE
    06 Mar 2026
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    Granules,SERP Join Handsto Strengthen Breast Cancer Screening
    Granules,SERP Join Handsto Strengthen Breast Cancer Screening

    28 Jan 2026

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    https://granulesindia.com/wp-content/uploads/2026/01/Granules-India-SERP-Join-Hands-to-Strengthen-Breast-Cancer-Screening-in-Sangareddy.pdf

    PRESS RELEASE
    28 Jan 2026
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    Q3FY26 Revenue from operations at INR 13,879 Mn up 22% YoY
    Q3FY26 Revenue from operations at INR 13,879 Mn up 22% YoY

    23 Jan 2026

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2026/01/Q3FY26-Revenue-from-operations-at-INR-13879-Mn-up-22-YoY-EBITDA-at-INR-3081-Mn-up-34-YoY-PBT-at-INR-2022-Mn-up-32-YoY-PAT-at-INR-1502-Mn-up-28-YoY.pdf

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    23 Jan 2026
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    Granules India Secures USFDA Tentative Approval For gDYANAVEL XR
    Granules India Secures USFDA Tentative Approval For gDYANAVEL XR

    08 Jan 2026

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    https://granulesindia.com/wp-content/uploads/2026/01/Granules-Pharmaceuticals-Inc.-Receives-FDA-Tentative-Approval-with-180-Day-Exclusivity-for-Generic-Amphetamine-Extended-Release-Tablets-DYANAVEL-XR.pdf

    PRESS RELEASE
    08 Jan 2026
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    ALL APIs

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    Metformin

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    Booth #E1K58
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-07-28

    Pay. Date : 2016-07-01

    DMF Number : 16625

    Submission : 2003-06-06

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 305MF10066

    Registrant's Address : 2nd Floor, 3rd Block My Home Hub, Madhapur, Hyderabad, Telangana 500081 India

    Initial Date of Registration : 2023-05-24

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-10-07

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0028

    Address of the Firm :

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    NDC Package Code : 62207-144

    Start Marketing Date : 2021-07-23

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (97mg/100mg)

    Marketing Category : EXPORT ONLY

    KDMF arrow-down
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    Registrant Name : Medipoem Co., Ltd.

    Registration Date : 2026-04-09

    Registration Number : 20050831-37-C-34-05(14)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District - 500 055 Telangana State, India

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    Available Reg. Filing : ASMF, CA, BR, MX
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    02

    Paracetamol

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17722

    Submission : 2004-09-22

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
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    Registration Number : 228MF10061

    Registrant's Address : 2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad, Telangana 500081 India

    Initial Date of Registration : 2016-02-24

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2025-08-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0116

    Address of the Firm :

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    NDC Package Code : 62207-934

    Start Marketing Date : 2025-04-14

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Insung Trading Co., Ltd.

    Registration Date : 2023-03-29

    Registration Number : 20050915-32-C-198-10(B)

    Manufacturer Name : Granules India Ltd

    Manufacturer Address : H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy Dist-502313, Telangana State, India.

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    03

    Guaifenesin

    India

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-19

    Pay. Date : 2014-03-11

    DMF Number : 14372

    Submission : 1999-08-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-10-07

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0028

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 62207-932

    Start Marketing Date : 2021-12-17

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : EXPORT ONLY

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    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2021-11-30

    Registration Number : 20210309-211-J-857(3)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State, India

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    Available Reg. Filing : ASMF, BR
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    Granules India

    04

    Guaifenesin

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20998

    Submission : 2007-10-31

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
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    Date of Issue : 2025-08-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0116

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-500

    Start Marketing Date : 2017-08-17

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (95mg/100mg)

    Marketing Category : DRUG FOR FURTHER PRO...

    KDMF arrow-down
    ✖

    Registrant Name : Daeshin Muyak Co., Ltd.

    Registration Date : 2021-07-05

    Registration Number : 20210309-211-J-857(2)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, Telangana State India

     VMF ASMF, BR arrow-down
    ✖
    Available Reg. Filing : ASMF, BR
    AUDIT arrow-down
    Granules India

    05

    Metformin

    India

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

    arrow
    CPhI China
    Booth #E1K58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17723

    Submission : 2004-09-22

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0116

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-416

    Start Marketing Date : 2021-03-25

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (500mg/kg)

    Marketing Category : DRUG FOR FURTHER PRO...

    KDMF arrow-down
    ✖

    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2023-01-13

    Registration Number : 20050831-37-C-34-05(13)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District - 500 055 Telangana State, India

     VMF ASMF, CA... arrow-down
    ✖
    Available Reg. Filing : ASMF, CA, BR, MX
    AUDIT arrow-down
    Granules India

    06

    Methocarbamol

    India

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

    arrow
    CPhI China
    Booth #E1K58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-28

    Pay. Date : 2013-08-12

    DMF Number : 17872

    Submission : 2004-12-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-10-07

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0028

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-022

    Start Marketing Date : 2024-04-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : EXPORT ONLY

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2012-02-24

    Registration Number : 20080110-81-D-18-01(7)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : Plot No.: 15 A/1, IDA, Phase –III, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District-500 055, Telangana State, India

     VMF ASMF, CA... arrow-down
    ✖
    Available Reg. Filing : ASMF, CA, CN
    AUDIT arrow-down
    Granules India

    07

    Paracetamol

    India

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

    arrow
    CPhI China
    Booth #E1K58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18978

    Submission : 2005-11-28

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-08-01

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0116

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-930

    Start Marketing Date : 2020-06-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : DRUG FOR FURTHER PRO...

    KDMF arrow-down
    ✖

    Registrant Name : Kenview Korea Sales Co., Ltd.

    Registration Date : 2023-03-03

    Registration Number : 20050915-32-C-198-10(A)

    Manufacturer Name : Granules India Ltd

    Manufacturer Address : H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy Dist-502313, Telangana State, India.

     VMF ASMF, CA... arrow-down
    ✖
    Available Reg. Filing : ASMF, CA, MX
    AUDIT arrow-down
    Granules India

    08

    Rifaximin

    India

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

    arrow
    CPhI China
    Booth #E1K58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36125

    Submission : 2021-08-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-146 - Rev 02

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2362

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62207-020

    Start Marketing Date : 2023-08-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT arrow-down
    Granules India

    09

    Eltrombopag

    India

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

    arrow
    CPhI China
    Booth #E1K58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-02-13

    Pay. Date : 2024-01-08

    DMF Number : 39129

    Submission : 2023-12-31

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-05-02

    Valid Till : 2025-05-01

    Written Confirmation Number : WC-0526

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-988

    Start Marketing Date : 2024-03-05

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF, CA... arrow-down
    ✖
    Available Reg. Filing : ASMF, CA, BR
    AUDIT arrow-down
    Granules India

    10

    Metoprolol Succinate

    India

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

    arrow
    CPhI China
    Booth #E1K58
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-05-27

    Pay. Date : 2021-04-19

    DMF Number : 33544

    Submission : 2019-03-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-05-02

    Valid Till : 2025-05-01

    Written Confirmation Number : WC-0526

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-970

    Start Marketing Date : 2021-03-25

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT arrow-down
    Granules India
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    Contact Granules India Limited and get a quotation

    Granules India Limited is a supplier offers 63 products (APIs, Excipients or Intermediates).

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