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    Company profile for Granules India Limited

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    Granules India posts Q4 FY25 PAT at Rs. 152 Cr

    29 May 2025

    // PRESS RELEASE

    Granules India completes acquisition of Senn Chemicals

    14 Apr 2025

    // PRESS RELEASE

    Granules India, AIG Hospitals host breast health camp for Telanga

    04 Apr 2025

    // EXPRESSPHARMA

    DATA COMPILATION
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    Granules India

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

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    About

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

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

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    Granules India Limitedindia-flag Flag
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    India
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    15th Floor, Granules Tower, Botanical Garden Road, Kondapur, Hyderabad – 500...
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    +91 4069043500
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    sales@granulesindia.com
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    VLOG #PharmaReel

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    ReelPharmaIntegrated player offering APIs, PFIs & FormulationsIntegrated player offering APIs, PFIs & Formulations

    Integrated player offering APIs, PFIs & Formulations
    Integrated player offering APIs, PFIs & Formulations

    reelIntegrated player offering APIs, PFIs & Formulations

    Granules India stands as a truly integrated pharmaceutical powerhouse, delivering APIs, PFIs, and formulations with a focus on scale and sustainability. Its growing portfolio now spans CNS/ADHD, Diabetes, and Oncology.

    Impressions: 458

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2025

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    Corporate Presentation

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    API Product List 2025

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    FDF Product List 2025

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    PFI Product List 2025

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    GMP Certificate 2025

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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
    24 Oct 2024
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    NEWS #PharmaBuzz

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    Granules India posts Q4 FY25 PAT at Rs. 152 Cr
    Granules India posts Q4 FY25 PAT at Rs. 152 Cr

    29 May 2025

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2025/05/Press-Release-Q4-FY25.pdf

    PRESS RELEASE
    29 May 2025
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    Granules India completes acquisition of Senn Chemicals
    Granules India completes acquisition of Senn Chemicals

    14 Apr 2025

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2025/04/Granules-India-Announces-Closing-of-Acquisition-of-Senn-Chemicals-Strengthening-Capabilities-in-Peptide-Therapeutics-and-CDMO-Services.pdf

    PRESS RELEASE
    14 Apr 2025
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    Granules India, AIG Hospitals host breast health camp for Telanga
    Granules India, AIG Hospitals host breast health camp for Telanga

    04 Apr 2025

    // EXPRESSPHARMA

    https://www.expresspharma.in/granules-india-and-aig-hospitals-conduct-breast-health-camp-for-women-police-officers-in-telangana/

    EXPRESSPHARMA
    04 Apr 2025
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    Granules India acquires Senn Chemical to foray into peptide & CDMO
    Granules India acquires Senn Chemical to foray into peptide & CDMO

    22 Feb 2025

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2025/04/Granules-India-Announces-Closing-of-Acquisition-of-Senn-Chemicals-Strengthening-Capabilities-in-Peptide-Therapeutics-and-CDMO-Services.pdf

    PRESS RELEASE
    22 Feb 2025
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    Granules Strengthens ADHD Portfolio with FDA Approval
    Granules Strengthens ADHD Portfolio with FDA Approval

    30 Jan 2025

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2025/01/Granules-Strengthens-ADHD-Portfolio-with-FDA-Approval-for-Lisdexamfetamine-Dimesylate-Capsules.pdf

    PRESS RELEASE
    30 Jan 2025
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    Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr
    Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr

    27 Jan 2025

    // PRESS RELEASE

    https://granulesindia.com/wp-content/uploads/2025/01/Press-Release-Q3-FY25.pdf

    PRESS RELEASE
    27 Jan 2025
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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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    CPhI WW Frankfurt
    Booth #H9.1A48
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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 2021-312 - Rev 01

    Issue Date : 2024-11-25

    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-WCInactive-api
    ✖

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0028n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-144

    Start Marketing Date : 2021-07-23

    End Marketing Date : 2025-12-31

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

    Marketing Category : EXPORT ONLY

    KDMF arrow-down
    ✖

    Registrant Name : Agerson Bio Co., Ltd.

    Registration Date : 2023-01-13

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

    Manufacturer Name : Granules India Limited

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

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    Available Reg. Filing : ASMF, BR, CA, MX
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    Granules India

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    02

    Paracetamol

    India

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

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    CPhI WW Frankfurt
    Booth #H9.1A48
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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
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17722

    Submission : 2004-09-22

    Status : Active

    Type : II

     CEP/COS 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-WCInactive-api
    ✖

    Date of Issue : 2022-06-29

    Valid Till : 2025-02-07

    Written Confirmation Number : WC-0116n

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 62207-934

    Start Marketing Date : 2025-04-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    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.

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    Available Reg. Filing : ASMF, CA, MX
    AUDIT
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    03

    Atazanavir Sulfate

    India

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

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    CPhI WW Frankfurt
    Booth #H9.1A48
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    USDMF arrow-down
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    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-WCInactive-api
    ✖

    Date of Issue : 2022-08-07

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0024n

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 62207-005

    Start Marketing Date : 2018-06-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : EXPORT ONLY

    KDMF VMF ASMF, MX arrow-down
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    Available Reg. Filing : ASMF, MX
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    04

    Guaifenesin

    India

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

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    CPhI WW Frankfurt
    Booth #H9.1A48
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-19

    Pay. Date : 2014-03-11

    DMF Number : 14372

    Submission : 1999-08-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2018-11-27

    Type : Chemical

    Substance Number : 615

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-06-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0028n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-932

    Start Marketing Date : 2021-12-17

    End Marketing Date : 2025-12-31

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

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

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    05

    Guaifenesin

    India

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

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    CPhI WW Frankfurt
    Booth #H9.1A48
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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
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20998

    Submission : 2007-10-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

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

    Issue Date : 2021-12-10

    Type : Chemical

    Substance Number : 615

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-06-29

    Valid Till : 2025-02-07

    Written Confirmation Number : WC-0116a1

    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 : 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, Telangana State India

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

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    06

    Losartan Potassium

    India

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

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    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 : 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-WCInactive-api
    ✖

    Date of Issue : 2022-08-07

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0024n

    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 : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2015-10-12

    Registration Number : 20100616-122-G-58-21(1)

    Manufacturer Name : Granules India Limited (Unit-IV)_x000D_

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

     VMF ASMF, CN arrow-down
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    Available Reg. Filing : ASMF, CN
    AUDIT
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    07

    Metformin

    India

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

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    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 : CEP 2018-120 - Rev 01

    Issue Date : 2023-12-12

    Type : Chemical

    Substance Number : 931

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-07

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0024n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-416

    Start Marketing Date : 2021-03-25

    End Marketing Date : 2025-12-31

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

    Marketing Category : EXPORT ONLY

    KDMF arrow-down
    ✖

    Registrant Name : Insung Trading Co., Ltd.

    Registration Date : 2022-05-17

    Registration Number : 20050831-37-C-34-05(11)

    Manufacturer Name : Granules India Limited

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

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

    Product
    Web Link

    Stock Recap
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    Market
    Place

    08

    Pirfenidone

    India

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

    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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-WCInactive-api
    ✖

    Date of Issue : 2022-08-07

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0024n

    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 arrow-down
    ✖

    Registrant Name : Insung Trading Co., Ltd.

    Registration Date : 2025-03-26

    Registration Number : 20250326-211-J-1822

    Manufacturer Name : Granules India Limited

    Manufacturer Address : Plot No 8, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District - 531021, Andhra Pradesh, India

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Rifaximin

    India

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

    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36125

    Submission : 2021-08-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2012-146 - Rev 02

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2362

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-07

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0024n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-020

    Start Marketing Date : 2023-08-30

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Trazodone Hydrochloride

    India

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

    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 : 2023-08-22

    Pay. Date : 2023-07-17

    DMF Number : 37593

    Submission : 2022-12-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-010 - Rev 00

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 2857

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2022-08-07

    Valid Till : 2025-06-26

    Written Confirmation Number : WC-0024n

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-019

    Start Marketing Date : 2023-01-16

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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    USDMF

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    01

    Acetaminophen Usp

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 Ibu 66s

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 : 20606

    Submission : 2007-06-12

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Compresso Ibu 85 Par (ibuprofen Gran...

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 : 35886

    Submission : 2021-05-18

    Status : Active

    Type : II

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Compresso Lsp 33.333 % (losartan Pot...

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    09

    Compresso Mf 95p

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    10

    Compresso Pap 90 Cpc

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
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    Market
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    CEP/COS

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    01

    Atazanavir sulfate

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    Cetirizine dihydrochloride

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    03

    Esomeprazole magnesium trihydrate

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 2022-012 - Rev 02

    Status : Valid

    Issue Date : 2024-12-13

    Type : Chemical

    Substance Number : 2372

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Guaifenesin

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
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    Market
    Place

    05

    Guaifenesin, BPL site

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    06

    Levetiracetam

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
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    Market
    Place

    07

    Losartan potassium, Process II

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    08

    Metformin Hydrochloride

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
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    Market
    Place

    09

    Metformin Hydrochloride, BPL Site

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
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    Market
    Place

    10

    Metformin Hydrochloride, Unit-IV Site

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 2021-312 - Rev 01

    Status : Valid

    Issue Date : 2024-11-25

    Type : Chemical

    Substance Number : 931

    Granules India

    Product
    Web Link

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    01

    Acetaminophen

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    02

    Acetaminophen

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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    Market
    Place

    03

    Acetaminophen

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 : Johnson & Johnson Korea Sales Co., Ltd.

    Registration Date : 2023-03-03

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

    Manufacturer Name : Granules India Ltd

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

    Granules India

    Product
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    Market
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    04

    Fexofenadine hydrochloride

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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 : Pharmapia Co., Ltd.

    Registration Date : 2025-03-11

    Registration Number : 20250311-209-J-1810

    Manufacturer Name : M/s. Granules India Limited (U...

    Manufacturer Address : Plot No.08, Jawaharlal Nehru Pharma City, Parawada Mandal, Visakhapatnam Dist 531 019...

    Granules India

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    Market
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    05

    Guaifenesin

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
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    Market
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    06

    Guaifenesin

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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    Market
    Place

    07

    Guaifenesin

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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    Market
    Place

    08

    Guaifenesin

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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    Market
    Place

    09

    Levocetirizine hydrochloride

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    10

    Levocetirizine hydrochloride

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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
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    NDC API

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    01

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-933

    Start Marketing Date : 2020-06-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : EXPORT ONLY

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    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 PROCESSING

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-930

    Start Marketing Date : 2020-06-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : EXPORT ONLY

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-204

    Start Marketing Date : 2013-10-04

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (89.605mg/89.605mg)

    Marketing Category : DRUG FOR FURTHER PROCESSING

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-702

    Start Marketing Date : 2013-04-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-202

    Start Marketing Date : 2009-05-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-200

    Start Marketing Date : 2019-11-05

    End Marketing Date : 2025-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-934

    Start Marketing Date : 2025-04-14

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    ACETAMINOPHEN

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-101

    Start Marketing Date : 2017-08-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : DRUG FOR FURTHER PROCESSING

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    ATAZANAVIR SULFATE

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

    NDC Package Code : 62207-005

    Start Marketing Date : 2018-06-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : EXPORT ONLY

    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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    LISTED APIs

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

    Atazanavir Sulfate

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    01

    Atazanavir Sulfate

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Avatrombopag Meleate

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    02

    Avatrombopag Meleate

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Bupropion Hydrochloride

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    03

    Bupropion Hydrochloride

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Cabozantinib

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    04

    Cabozantinib

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Cetirizine Dihydrochloride

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    05

    Cetirizine Dihydrochloride

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Dapagliflozin

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    06

    Dapagliflozin

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Dasatinib

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    07

    Dasatinib

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Dimethyl Fumarate

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    08

    Dimethyl Fumarate

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Elacestrant

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    09

    Elacestrant

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    Granules India

    Product
    Web Link

    Stock Recap
    #Pipeline Prospector

    Market
    Place

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

    Eltrombopag Olamine

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

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

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

    Granules India

    10

    Eltrombopag Olamine

    India
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48
    • 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

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

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

    About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value c...

    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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    FDA Orange Book

    read-more
    read-more

    01

    Brand Name : ACETAMINOPHEN

    India
    CPhI WW Frankfurt
    Booth #H9.1A48
    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

    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    #PipelineProspector

    Market
    Place

    03

    Brand Name : BUTALBITAL AND ACETA...

    India
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    CPhI WW Frankfurt
    Booth #H9.1A48
    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
    Place

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

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    Inspections and registrations

    Check the inspections & registration from this company

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : No Action Indicated

    Inspection End Date : 2024-04-12

    Granules India Limited

    City : Parawada Mandal

    State :

    Country/Area : IN

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2024-04-12

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    02

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-12-15

    Granules India Limited

    City : Chantilly

    State : Virginia

    Country/Area : US

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-12-15

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    03

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : No Action Indicated

    Inspection End Date : 2023-08-03

    Granules India Limited

    City : Chantilly

    State : Virginia

    Country/Area : US

    Zip :

    District :

    Center :

    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2023-08-03

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    04

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : No Action Indicated

    Inspection End Date : 2023-06-30

    Granules India Limited

    City : Visakhapatnam

    State :

    Country/Area : IN

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2023-06-30

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    05

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : No Action Indicated

    Inspection End Date : 2023-06-23

    Granules India Limited

    City : Secunderabad

    State :

    Country/Area : IN

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2023-06-23

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    06

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-07-22

    Granules India Limited

    City : Chantilly

    State : Virginia

    Country/Area : US

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-07-22

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    07

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-14

    Granules India Limited

    City : Medchal-Malkhajgiri Distr...

    State :

    Country/Area : IN

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-14

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    08

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-16

    Granules India Limited

    City : Parawada Mandal

    State :

    Country/Area : IN

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-16

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    09

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-07-26

    Granules India Limited

    City : Sangareddy District

    State :

    Country/Area : IN

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-07-26

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

    10

    FDA Audited

    USA
    arrow
    CPhI WW Frankfurt
    Booth #H9.1A48

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-23

    Granules India Limited

    City : Secunderabad

    State :

    Country/Area : IN

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-03-23

    Granules India

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Data Compilation
    #PharmaFlow

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    ABOUT THIS PAGE

    Contact Granules India Limited and get a quotation

    Granules India Limited is a supplier offers 50 products (APIs, Excipients or Intermediates).

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