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    EDQM Issued CEP Certificate for “metformin HCl Process-II”

    06 Mar 2026

    // PRESS RELEASE

    Disclosure pursuant to Regulation 30 of the SEBI 2015

    02 Mar 2026

    // PRESS RELEASE

    EDQM Issued CEP Certificate for “clopidogrel Besilate”

    24 Feb 2026

    // PRESS RELEASE

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    01 1Allopurinol

    02 1Allopurinol Sodium

    03 1Apixaban

    04 1Choline Fenofibrate

    05 2Clopidogrel

    06 1Clopidogrel Besylate

    07 1Clopidogrel Hydrochloride

    08 1Edoxaban Tosylate

    09 1Fenofibrate

    10 1Gabapentin

    11 3Ibuprofen

    12 1Ibuprofen Lysinate

    13 1Ibuprofen Piconol

    14 1Ibuprofen Sodium

    15 2Lamotrigine

    16 1Levetiracetam

    17 1Losartan Potassium

    18 1Mesalazine

    19 2Metformin

    20 1Minoxidil

    21 1Pantoprazole Magnesium

    22 3Pantoprazole Sodium

    23 2Paracetamol

    24 1Quetiapine Hemifumarate

    25 1Sacubitril-Valsartan

    26 1Sitagliptin Phosphate

    27 1Theophylline

    28 1Valsartan

    29 1Vildagliptin

    30 1Blank

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    01

    Clopidogrel

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36534

    Submission : 2022-06-16

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2019-006 - Rev 02

    Issue Date : 2026-01-27

    Type : Chemical

    Substance Number : 2531

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

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    NDC Package Code : 49716-329

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2025-02-28

    Registration Number : 20250228-129-H-431-62

    Manufacturer Name : IOL Chemicals and Pharmaceuticals Limited

    Manufacturer Address : Village: Fatebgarh Channa, Mansa Road (Trident Complex) Barnala-148101(Punjab), India

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    Available Reg. Filing : RU
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    02

    Fenofibrate

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2024-02-05

    Pay. Date : 2023-12-22

    DMF Number : 36535

    Submission : 2022-01-05

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2018-075 - Rev 03

    Issue Date : 2023-11-02

    Type : Chemical

    Substance Number : 1322

    Status : Valid

     JDMF EU-WCarrow-down
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    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

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    NDC Package Code : 49716-330

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2021-06-22

    Registration Number : 20210622-209-J-854

    Manufacturer Name : IOL Chemicals and Pharmaceuticals Limited

    Manufacturer Address : IOL Chemicals and Pharmaceuticals LimitedVillage Fatehgarh Channa, Mansa Road(Trident Complex)District-BarnalaState-Punjab, 148101India

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    Available Reg. Filing : RU
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    03

    Ibuprofen

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-13

    Pay. Date : 2014-06-09

    DMF Number : 22431

    Submission : 2009-01-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-316 - Rev 05

    Issue Date : 2022-07-27

    Type : Chemical

    Substance Number : 721

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

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    NDC Package Code : 49716-325

    Start Marketing Date : 2017-06-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2025-01-31

    Registration Number : 20250131-145-I-694-11

    Manufacturer Name : IOL Chemicals and Pharmaceuticals Limited

    Manufacturer Address : Village: Fatehgarh Channa, Mansa Road (Trident Complex) Barnala-148101(Punjab) India

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    04

    Lamotrigine

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 26627

    Submission : 2012-11-15

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2013-066 - Rev 02

    Issue Date : 2026-04-09

    Type : Chemical

    Substance Number : 1756

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 49716-331

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    Available Reg. Filing : RU
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    05

    Levetiracetam

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-01-24

    Pay. Date : 2024-12-02

    DMF Number : 36374

    Submission : 2021-11-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-343 - Rev 00

    Issue Date : 2022-11-07

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 49716-332

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2023-07-06

    Registration Number : 20230706-183-I-661-33

    Manufacturer Name : IOL Chemicals and Pharmaceuticals Limited

    Manufacturer Address : Village: Fatebgarh Channa, Mansa Road (Trident Complex) Bamala-148101(Punjab) India

     VMF Others AUDIT arrow-down
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    06

    Losartan Potassium

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37106

    Submission : 2022-09-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-380 - Rev 00

    Issue Date : 2024-02-05

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 49716-333

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT arrow-down
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    07

    Metformin

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 27139

    Submission : 2013-05-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-188 - Rev 01

    Issue Date : 2022-11-03

    Type : Chemical

    Substance Number : 931

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 49716-336

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : JL Bio Co., Ltd.

    Registration Date : 2025-10-10

    Registration Number : 20251010-37-C-439-33

    Manufacturer Name : IOL Chemicals and Pharmaceuticals Ltd

    Manufacturer Address : Village Fatehgarh Channa, Mansa Road, Trident Complex, Barnala-148101, Punjab, INDIA

     VMF RU arrow-down
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    Available Reg. Filing : RU
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    IOL Chemicals

    08

    Pantoprazole Sodium

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36375

    Submission : 2021-12-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-427 - Rev 00

    Issue Date : 2022-11-02

    Type : Chemical

    Substance Number : 2296

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 49716-334

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF RU arrow-down
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    Available Reg. Filing : RU
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    09

    Paracetamol

    India

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

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    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-02-28

    Pay. Date : 2025-01-23

    DMF Number : 37336

    Submission : 2022-07-28

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-085 - Rev 01

    Issue Date : 2026-03-12

    Type : Chemical

    Substance Number : 49

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-02-27

    Valid Till : 2028-03-17

    Written Confirmation Number : WC-0004

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 49716-327

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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

    Registration Date : 2025-02-03

    Registration Number : 20250203-32-C-419-27

    Manufacturer Name : IOL Chemicals and Pharmaceuticals Ltd

    Manufacturer Address : Village Fatehgarh Channa,Mansa Road, Trident Complex,Barnala-148101, Punjab, INDIA

     VMF Others AUDIT arrow-down
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    10

    Allopurinol

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37104

    Submission : 2023-01-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-029 - Rev 00

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 576

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 49716-328

    Start Marketing Date : 2023-10-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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