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    Nomura Upgrade Lifts Dr Reddy's Share Over 4%

    29 Dec 2024

    // BUSINESS STD

    Granules India gets USFDA nod for ADHD Treatment

    17 Dec 2024

    // PRESS RELEASE

    Granules`s Generics Lisdexamfetamine Receives Approval in US

    16 Dec 2024

    // FDA

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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)
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    +91 4069043500
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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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    #PharmaFlow by PHARMACOMPASS
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    NEWS #PharmaBuzz

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    Nomura Upgrade Lifts Dr Reddy's Share Over 4%
    Nomura Upgrade Lifts Dr Reddy's Share Over 4%

    29 Dec 2024

    // BUSINESS STD

    https://www.business-standard.com/companies/news/granules-india-expects-fda-nod-for-drug-from-gagillapur-facility-by-fy26-124122900434_1.html

    BUSINESS STD
    29 Dec 2024
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    Granules India gets USFDA nod for ADHD Treatment
    Granules India gets USFDA nod for ADHD Treatment

    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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    ALL APIs

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    01

    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 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
    Not Confirmed
    • 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 : 2025-12-31

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

    Marketing Category : DRUG FOR FURTHER PRO...

    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
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    Market
    Place

    03

    Atazanavir Sulfate

    India

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

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    Pharma, Lab & Chemical Expo
    Not Confirmed
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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 : 2025-12-31

    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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    Web Link

    Stock Recap
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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
    Not Confirmed
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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
    • 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 : 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 : 2025-12-31

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

    Marketing Category : DRUG FOR FURTHER PRO...

    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 : 2025-12-31

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

    Marketing Category : DRUG FOR FURTHER PRO...

    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

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    07

    Losartan Potassium

    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 : 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
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    USDMF

    read-more
    read-more

    01

    Acetaminophen Usp

    India
    arrow
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Duphat
    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
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    CEP/COS

    read-more
    read-more

    01

    Atazanavir sulfate

    India
    arrow
    BIO Partnering at JPM
    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

    Certificate Numbers : CEP 2020-279 - Rev 01

    Status : Valid

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2898

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Capecitabine

    India
    arrow
    BIO Partnering at JPM
    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

    Certificate Numbers : CEP 2019-091 - Rev 01

    Status : Valid

    Issue Date : 2024-06-06

    Type : Chemical

    Substance Number : 2762

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Cetirizine dihydrochloride

    India
    arrow
    BIO Partnering at JPM
    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

    Certificate Numbers : CEP 2009-349 - Rev 02

    Status : Valid

    Issue Date : 2024-10-16

    Type : Chemical

    Substance Number : 1084

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Gliclazide

    India
    arrow
    BIO Partnering at JPM
    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

    Certificate Numbers : CEP 2017-240 - Rev 02

    Status : Valid

    Issue Date : 2024-10-14

    Type : Chemical

    Substance Number : 1524

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Guaifenesin

    India
    arrow
    BIO Partnering at JPM
    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

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

    Status : Valid

    Issue Date : 2018-11-27

    Type : Chemical

    Substance Number : 615

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Guaifenesin, BPL site

    India
    arrow
    BIO Partnering at JPM
    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

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

    Status : Valid

    Issue Date : 2021-12-10

    Type : Chemical

    Substance Number : 615

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Levetiracetam

    India
    arrow
    BIO Partnering at JPM
    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

    Certificate Numbers : CEP 2023-138 - Rev 00

    Status : Valid

    Issue Date : 2024-07-05

    Type : Chemical

    Substance Number : 2535

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Losartan potassium, Process II

    India
    arrow
    BIO Partnering at JPM
    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

    Certificate Numbers : CEP 2020-333 - Rev 03

    Status : Valid

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2232

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Metformin Hydrochloride

    India
    arrow
    BIO Partnering at JPM
    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

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

    Status : Valid

    Issue Date : 2023-05-05

    Type : Chemical

    Substance Number : 931

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Metformin Hydrochloride, BPL Site

    India
    arrow
    BIO Partnering at JPM
    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

    Certificate Numbers : CEP 2018-120 - Rev 01

    Status : Valid

    Issue Date : 2023-12-12

    Type : Chemical

    Substance Number : 931

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

    read-more
    read-more

    01

    Acetaminophen

    India
    arrow
    PharmaVenue
    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

    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 Dis...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    02

    Acetaminophen

    India
    arrow
    PharmaVenue
    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

    Registrant Name : Korea Johnson & Johnson 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 Dis...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    03

    Acetaminophen

    India
    arrow
    PharmaVenue
    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

    Registrant Name : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2005-09-15

    Registration Number : 20050915-32-C-198-10

    Manufacturer Name : Granules India Ltd

    Manufacturer Address : H. No.: 6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy ...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    04

    Guaifenesin

    India
    arrow
    PharmaVenue
    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

    Registrant Name : Insung Trading Co., Ltd.

    Registration Date : 2021-03-09

    Registration Number : 20210309-211-J-857

    Manufacturer Name : Granules India Limited

    Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    05

    Guaifenesin

    India
    arrow
    PharmaVenue
    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

    Registrant Name : Daeshin Pharmaceutical 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, T...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    06

    Guaifenesin

    India
    arrow
    PharmaVenue
    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

    Registrant Name : IMCD Korea Co., Ltd.

    Registration Date : 2021-06-04

    Registration Number : 20210309-211-J-857(1)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist-500 055.,Tela...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    07

    Guaifenesin

    India
    arrow
    PharmaVenue
    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

    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, T...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    08

    Levocetirizine hydrochloride

    India
    arrow
    PharmaVenue
    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

    Registrant Name : Dongkwang Pharmaceutical Co., Ltd.

    Registration Date : 2016-02-25

    Registration Number : 20090720-40-C-258-15(2)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    09

    Levocetirizine hydrochloride

    India
    arrow
    PharmaVenue
    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

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2009-07-20

    Registration Number : 20090720-40-C-258-15

    Manufacturer Name : Granules India Limited_x000D_

    Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    10

    Levocetirizine hydrochloride

    India
    arrow
    PharmaVenue
    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

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2016-05-02

    Registration Number : 20090720-40-C-258-15(3)

    Manufacturer Name : Granules India Limited

    Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Vitsakhapatna...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

    Only 10 entries up to this point, click to access all click full view read-more
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    Drugs in Development

    read-more
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    • Development Update
    • fda
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    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution

    Details:

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


    Lead Product(s): Glycopyrronium Bromide

    Therapeutic Area: Neurology Brand Name: Cuvposa-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 20, 2024

    Granules India

    01

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Glycopyrronium Bromide

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Gets USFDA Nod for Generic Glycopyrrolate Oral Solution

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

    Brand Name : Cuvposa-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 20, 2024

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Gains ANDA approval for Trazodone Tablets

    Details:

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


    Lead Product(s): Trazodone Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Desyrel-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 09, 2024

    Granules India

    02

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Trazodone Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Gains ANDA approval for Trazodone Tablets

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

    Brand Name : Desyrel-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 09, 2024

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Received ANDA Approval for Pantoprazole Sod Delayed-Release Tablets

    Details:

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


    Lead Product(s): Pantoprazole Sodium

    Therapeutic Area: Gastroenterology Brand Name: Protonix-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 13, 2023

    Granules India

    03

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Pantoprazole Sodium

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

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

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

    Brand Name : Protonix-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 13, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Received ANDA Approval for Sildenafil for Oral Suspension

    Details:

    Sildenafil is an inhibitor of cyclic GMP specific PDE type 5, the predominant enzyme metabolizing cyclic GMP in the corpus cavernosum. It is indicated for pulmonary arterial hypertension in adults.


    Lead Product(s): Sildenafil Citrate

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Revatio-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 03, 2023

    Granules India

    04

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Sildenafil Citrate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Limited Received ANDA Approval for Sildenafil for Oral Suspension

    Details : Sildenafil is an inhibitor of cyclic GMP specific PDE type 5, the predominant enzyme metabolizing cyclic GMP in the corpus cavernosum. It is indicated for pulmonary arterial hypertension in adults.

    Brand Name : Revatio-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 03, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Gets USFDA Nod for Generic Drug Used for Short-term Treatment of Heartburn

    Details:

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


    Lead Product(s): Esomeprazole Magnesium

    Therapeutic Area: Gastroenterology Brand Name: Nexium-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 19, 2023

    Granules India

    05

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Esomeprazole Magnesium

    Therapeutic Area : Gastroenterology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

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

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

    Brand Name : Nexium-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 19, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Received ANDA Approval for Losartan and Hydrochlorothiazide Tablets

    Details:

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


    Lead Product(s): Losartan Potassium,Hydrochlorothiazide

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Hyzaar-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 30, 2023

    Granules India

    06

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Losartan Potassium,Hydrochlorothiazide

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Limited Received ANDA Approval for Losartan and Hydrochlorothiazide Tablets

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

    Brand Name : Hyzaar-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 30, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    FDA Approves Granules' OTC Equivalent Of Advil Dual Action Tablets

    Details:

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


    Lead Product(s): Ibuprofen

    Therapeutic Area: Neurology Brand Name: Advil-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 14, 2023

    Granules India

    07

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Ibuprofen

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Approves Granules' OTC Equivalent Of Advil Dual Action Tablets

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

    Brand Name : Advil-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 14, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Receives ANDA Approval for Levetiracetam Tablets in record 9 months

    Details:

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


    Lead Product(s): Levetiracetam

    Therapeutic Area: Neurology Brand Name: Keppra-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 14, 2023

    Granules India

    08

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Levetiracetam

    Therapeutic Area : Neurology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

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

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

    Brand Name : Keppra-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 14, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Received ANDA Approval for Metoprolol Succinate ER Tablets

    Details:

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


    Lead Product(s): Metoprolol Succinate

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Toprol-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 13, 2023

    Granules India

    09

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Metoprolol Succinate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Limited Received ANDA Approval for Metoprolol Succinate ER Tablets

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

    Brand Name : Toprol-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 13, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
    • 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 Received ANDA Approval for Venlafaxine ER Capsules

    Details:

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


    Lead Product(s): Venlafaxine Hydrochloride

    Therapeutic Area: Psychiatry/Psychology Brand Name: Effexor-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable May 19, 2023

    Granules India

    10

    Granules India Limited

    India
    arrow
    BIO Partnering at JPM
    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.

    Lead Product(s) : Venlafaxine Hydrochloride

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Granules India Limited Received ANDA Approval for Venlafaxine ER Capsules

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

    Brand Name : Effexor-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    May 19, 2023

    Granules India

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

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    FDA Orange Book

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    01

    Brand Name : ACETAMINOPHEN

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

    RLD : No

    TE Code :

    ACETAMINOPHEN

    Granules India Limited

    Dosage Form : TABLET, EXTENDED RELEASE; ORAL

    Proprietary Name : ACETAMINOPHEN

    Dosage Strength : 650MG

    Approval Date : 2019-04-16

    Application Number : 211544

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Brand Name : ACETAMINOPHEN, ASPIR...

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

    RLD : No

    TE Code :

    ACETAMINOPHEN; ASPIRIN; CAFFEINE

    Granules India Limited

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN, ASPIRIN A...

    Dosage Strength : 250MG;250MG;65MG

    Approval Date : 2021-02-23

    Application Number : 214039

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

    Granules India

    Product
    Web Link

    Stock Recap
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    Market
    Place

    03

    Brand Name : BUTALBITAL AND ACETA...

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

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; BUTALBITAL

    Granules India Limited

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL AND ACETAMINO...

    Dosage Strength : 300MG;50MG

    Approval Date : 2019-11-22

    Application Number : 213115

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Brand Name : BUTALBITAL, ACETAMIN...

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

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Granules India Limited

    Dosage Form : TABLET; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 325MG;50MG;40MG

    Approval Date : 2008-12-01

    Application Number : 40864

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Brand Name : BUTALBITAL, ACETAMIN...

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

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; BUTALBITAL; CAFFEINE

    Granules India Limited

    Dosage Form : CAPSULE; ORAL

    Proprietary Name : BUTALBITAL, ACETAMINOPHE...

    Dosage Strength : 300MG;50MG;40MG

    Approval Date : 2020-04-08

    Application Number : 213321

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Brand Name : HYDROCODONE BITARTRA...

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

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; HYDROCODONE BITARTRATE

    Granules India Limited

    Dosage Form : TABLET; ORAL

    Proprietary Name : HYDROCODONE BITARTRATE A...

    Dosage Strength : 325MG;5MG

    Approval Date : 2020-01-03

    Application Number : 211729

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Brand Name : HYDROCODONE BITARTRA...

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

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; HYDROCODONE BITARTRATE

    Granules India Limited

    Dosage Form : TABLET; ORAL

    Proprietary Name : HYDROCODONE BITARTRATE A...

    Dosage Strength : 325MG;7.5MG

    Approval Date : 2020-01-03

    Application Number : 211729

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Brand Name : HYDROCODONE BITARTRA...

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

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; HYDROCODONE BITARTRATE

    Granules India Limited

    Dosage Form : TABLET; ORAL

    Proprietary Name : HYDROCODONE BITARTRATE A...

    Dosage Strength : 325MG;10MG

    Approval Date : 2020-01-03

    Application Number : 211729

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Brand Name : ACETAMINOPHEN AND IB...

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

    RLD : No

    TE Code :

    ACETAMINOPHEN; IBUPROFEN

    Granules India Limited

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAMINOPHEN AND IBUPRO...

    Dosage Strength : 250MG;125MG

    Approval Date : 2023-07-13

    Application Number : 216592

    RX/OTC/DISCN : OTC

    RLD : No

    TE Code :

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Brand Name : OXYCODONE AND ACETAM...

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

    RLD : No

    TE Code : AA

    ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    Granules India Limited

    Dosage Form : TABLET; ORAL

    Proprietary Name : OXYCODONE AND ACETAMINOP...

    Dosage Strength : 325MG;2.5MG

    Approval Date : 2019-10-31

    Application Number : 211708

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AA

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    Inspections and registrations

    Check the inspections & registration from this company

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-11-12

    Granules India Limited

    City : Qutbullapur Mandal, Ranga...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2009-11-12

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2010-11-22

    Granules India Limited

    City : Bonthapally, Medak Distri...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2010-11-22

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    03

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-09-13

    Granules India Limited

    City : Qutbullapur Mandal, Ranga...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-09-13

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2013-06-14

    Granules India Limited

    City : Visakhapatnam

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2013-06-14

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-13

    Granules India Limited

    City : Bonthapally, Medak Distri...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-06-13

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-03-13

    Granules India Limited

    City : Qutbullapur Mandal, Ranga...

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-03-13

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    07

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-05-08

    Granules India Limited

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-05-08

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    08

    FDA Audited

    USA
    arrow
    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-03-06

    Granules India Limited

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-03-06

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    EDQM

    read-more
    read-more

    01

    GMP Certified

    EU
    arrow
    Duphat
    Not Confirmed

    Granules India Limited

    Type : GMP Certificates

    Number : FI21/01/201...

    EudraGMDP Key : 21874

    Country : India

    Issue Date : 2013-12-16

    Post Code : 502313

    NCA Ref : 1.04721299e+...

    City : Medak District

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    02

    GMP Certified

    EU
    arrow
    Duphat
    Not Confirmed

    Granules India Limited

    Type : GMP Certificates

    Number : FI22/01/201...

    EudraGMDP Key : 21875

    Country : India

    Issue Date : 2013-12-16

    Post Code : 500 043

    NCA Ref : 104621298630...

    City : Quthbullapur Mandal, Ra...

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    03

    GMP Certified

    EU
    arrow
    Duphat
    Not Confirmed

    Granules India Limited

    Type : GMP Certificates

    Number : FT052/S1/MH...

    EudraGMDP Key : 31856

    Country : India

    Issue Date : 2015-10-26

    Post Code : 500 055

    NCA Ref : 104621298632...

    City : Hyderabad

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    GMP Certified

    EU
    arrow
    Duphat
    Not Confirmed

    Granules India Limited

    Type : GMP Certificates

    Number : FI21/01/201...

    EudraGMDP Key : 25980

    Country : India

    Issue Date : 2014-10-27

    Post Code : 502313

    NCA Ref : 104721298997...

    City : Medak District

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    GMP Certified

    EU
    arrow
    Duphat
    Not Confirmed

    Granules India Limited

    Type : GMP Certificates

    Number : HMP/PT/221/...

    EudraGMDP Key : 28131

    Country : India

    Issue Date : 2014-11-19

    Post Code : 500055

    NCA Ref : A0372917466

    City : HYDERABAD, ANDHRA PRADE...

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    GMP Certified

    EU
    arrow
    Duphat
    Not Confirmed

    Granules India Limited

    Type : GMP Certificates

    Number : FT022/MH/00...

    EudraGMDP Key : 40343

    Country : India

    Issue Date : 2017-02-24

    Post Code : 500043

    NCA Ref : FT022

    City : Ranga Reddy District

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    ABOUT THIS PAGE

    Contact Granules India Limited and get a quotation

    Granules India Limited is a supplier offers 62 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 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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