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    Granules India gets USFDA nod for generic drug

    17 Dec 2024

    // PRESS RELEASE

    Granules`s Generics Lisdexamfetamine Receives Approval in US

    16 Dec 2024

    // FDA

    Granules India updates on FDA inspection at Gagillapur Facility

    04 Dec 2024

    // PRESS RELEASE

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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 vertically integrated fast-growing Pharmaceutical company headquartered in Hyderabad with best-in-class facilities & a commitment to operational excellence, quality, & customer service. The company is present in the manufacturing of the entire value chain – from APIs, Formulation Intermediates, & Formulations. Their products are being distributed to over 300+ customers with a global presence extending to over 80+ countries with offices across India, US & UK.

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    Granules India Limitedindia-flag Flag
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    India
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    2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500 081 (TG)
    Telephone
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    +91 4069043500
    Client Email
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    sales@granulesindia.com
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    https://granulesindia.com/
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    Corporate Presentation

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    API Product List 2024

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    FDF Product List 2024

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    PFI Product List 2024

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    GMP Certificate 2020

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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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    24 Oct 2024
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    Granules India gets USFDA nod for generic drug
    Granules India gets USFDA nod for generic drug

    17 Dec 2024

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2024/12/Granules-India-Limited-Announces-FDA-Approval-for-ADHD-Treatment-Addressing-Drug-Shortages-in-the-U.S.pdf

    PRESS RELEASE
    17 Dec 2024
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    Granules`s Generics Lisdexamfetamine Receives Approval in US
    Granules`s Generics Lisdexamfetamine Receives Approval in US

    16 Dec 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219258

    FDA
    16 Dec 2024
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    Granules India updates on FDA inspection at Gagillapur Facility
    Granules India updates on FDA inspection at Gagillapur Facility

    04 Dec 2024

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2024/12/GIL-Confirms-USFDA-Classification-Does-Not-Impact-Ongoing-Operations-Assures-Commitment-to-Compliance-and-Growth.pdf

    PRESS RELEASE
    04 Dec 2024
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    Granules’ net zero commitment approved by SBTi
    Granules’ net zero commitment approved by SBTi

    30 Nov 2024

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2024/11/Granules-Net-Zero-Commitment-Validated-and-Approved-by-Science-Based-Targets-Initiative.pdf

    PRESS RELEASE
    30 Nov 2024
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    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
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    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
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    ALL APIs

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    01

    Metformin

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down Click Us! arrow-down
    ✖

    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 arrow-down
    ✖

    Certificate Number : CEP 2018-120 - Rev 01

    Issue Date : 2023-12-12

    Type : Chemical

    Substance Number : 931

    Status : Valid

     JDMF arrow-down
    ✖

    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
    ✖

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0028

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-012

    Start Marketing Date : 2017-10-24

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2023-01-13

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

    Manufacturer Name : M/s Granules India Limited

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

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

    Product
    Web Link

    Stock Recap
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    Market
    Place

    02

    Paracetamol

    India

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

    arrow
    Pharma, Lab & Chemical Expo
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    • fda
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    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 : 17722

    Submission : 2004-09-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 1998-047 - Rev 06

    Issue Date : 2018-01-19

    Type : Chemical

    Substance Number : 49

    Status : Valid

     JDMF arrow-down
    ✖

    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
    ✖

    Date of Issue : 2022-06-29

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0116

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-100

    Start Marketing Date : 2009-10-22

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (90mg/100mg)

    Marketing Category : EXPORT ONLY

    KDMF arrow-down
    ✖

    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.

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Atazanavir Sulfate

    India

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

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    Pharma, Lab & Chemical Expo
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    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 : 32259

    Submission : 2017-12-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-279 - Rev 01

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2898

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-08

    Valid Till : 2025-06-28

    Written Confirmation Number : WC-0024

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-005

    Start Marketing Date : 2018-06-11

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : EXPORT ONLY

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

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    04

    Cetirizine Dihydrochloride

    India

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

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    Pharma, Lab & Chemical Expo
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    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 : 2016-03-23

    Pay. Date : 2015-12-14

    DMF Number : 30063

    Submission : 2016-02-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2009-349 - Rev 02

    Issue Date : 2024-10-16

    Type : Chemical

    Substance Number : 1084

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-08

    Valid Till : 2025-06-28

    Written Confirmation Number : WC-0024

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-001

    Start Marketing Date : 2016-12-06

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/1)

    Marketing Category : EXPORT ONLY

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Guaifenesin

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    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 : 2014-03-19

    Pay. Date : 2014-03-11

    DMF Number : 14372

    Submission : 1999-08-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-332 - Rev 00

    Issue Date : 2021-12-10

    Type : Chemical

    Substance Number : 615

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0028

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-500

    Start Marketing Date : 2017-08-17

    End Marketing Date : 2024-12-31

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

    Marketing Category : EXPORT ONLY

    KDMF arrow-down
    ✖

    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

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Guaifenesin

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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 : 20998

    Submission : 2007-10-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-201 - Rev 03

    Issue Date : 2018-11-27

    Type : Chemical

    Substance Number : 615

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-29

    Valid Till : 2025-07-02

    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 : 2024-12-31

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

    Marketing Category : EXPORT ONLY

    KDMF arrow-down
    ✖

    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

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

    Product
    Web Link

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    Place

    07

    Losartan Potassium

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
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    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 : 2020-10-09

    Pay. Date : 2020-09-08

    DMF Number : 22711

    Submission : 2009-04-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2020-333 - Rev 03

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-08

    Valid Till : 2025-06-28

    Written Confirmation Number : WC-0024

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-007

    Start Marketing Date : 2018-04-09

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2016-05-02

    Registration Number : 20100616-122-G-58-21(2)

    Manufacturer Name : Granules India Limited (Unit-IV)

    Manufacturer Address : Plat No.8, JN. Pharma City, Tadi (V), Parawada Mandal, Visakhapatnam District, Andhra Pradesh India

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

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    08

    Metformin

    India

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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 arrow-down
    ✖

    Certificate Number : R1-CEP 2004-124 - Rev 07

    Issue Date : 2023-05-05

    Type : Chemical

    Substance Number : 931

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-29

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0116

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-012

    Start Marketing Date : 2017-10-24

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2023-01-13

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

    Manufacturer Name : M/s Granules India Limited

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

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Metoprolol Succinate

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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 arrow-down
    ✖

    Certificate Number : CEP 2019-232 - Rev 02

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 1448

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Pirfenidone

    India

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

    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • 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 : 2018-09-19

    Pay. Date : 2018-08-03

    DMF Number : 30922

    Submission : 2016-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-288 - Rev 01

    Issue Date : 2024-06-06

    Type : Chemical

    Substance Number : 2856

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-08

    Valid Till : 2025-06-28

    Written Confirmation Number : WC-0024

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-004

    Start Marketing Date : 2018-02-20

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    Only 10 entries up to this point, click to access all click full view read-more
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    USDMF

    read-more
    read-more

    01

    Acetaminophen Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    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

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Atazanavir Sulfate

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32259

    Submission : 2017-12-27

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Bupropion Hydrochloride Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    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

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Cetirizine Hydrochloride, Usp

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    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

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Compresso Ggf 95 Sa (guaifenesin Gra...

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20998

    Submission : 2007-10-31

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Compresso Lsp 33.333 % (losartan Pot...

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36088

    Submission : 2021-07-12

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Compresso Mf 95p

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17723

    Submission : 2004-09-22

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Compresso Pap 90 Cpc

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19972

    Submission : 2006-11-16

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Compresso Pap 90 Cpf

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17722

    Submission : 2004-09-22

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Compresso Pap 90 Cpl

    India
    arrow
    Pharma, Lab & Chemical Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Limited

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18978

    Submission : 2005-11-28

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    ABOUT THIS PAGE

    Contact Granules India Limited and get a quotation

    Granules India Limited is a supplier offers 63 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 Capecitabine bulk with 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 Gliclazide bulk with CEP, WC 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 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 Penicillamine bulk with CEP, WC offered by Granules India Limited

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Find a price of Olmesartan Medoxomil bulk with WC 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 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 Teneligliptin Hydrobromide bulk with WC offered by Granules India Limited

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

    Find a price of Tizanidine HCl 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

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