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    EVENTS

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    About

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

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    CONTACT DETAILS

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    Shilpa Medicareindia-flag Flag
    Country
    Country
    India
    Address
    Address
    1st Floor, 10/80, Rajendra Gunj, RAICHUR - 584 102 Karnataka
    Telephone
    Telephone
    +91-8532-236494
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.vbshilpa.com/
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    Linkedin
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    Twitter

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    NEWS #PharmaBuzz

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    FDA Approves Shilpa & mAbTree Therapy for Rare Blood Disorder
    FDA Approves Shilpa & mAbTree Therapy for Rare Blood Disorder

    30 Jan 2026

    // INDPHARMAPOST

    https://www.indianpharmapost.com/drug-approval/shilpa-medicare-mabtree-biologics-win-fda-nod-for-rare-blood-cancer-therapy-18998

    INDPHARMAPOST
    30 Jan 2026
    Share Share
    Shilpa Medicare Seeks US Approval for 5-HT3 Antagonist in CINV
    Shilpa Medicare Seeks US Approval for 5-HT3 Antagonist in CINV

    12 Jan 2026

    // PHARMIWEB

    https://www.pharmiweb.com/press-release/2026-01-12/shilpa-medicare-targets-us-approval-of-5-ht3-receptor-antiemetic-for-chemotherapy-induced-nausea-and-vomiting-cinv

    PHARMIWEB
    12 Jan 2026
    Share Share
    Shilpa Medicare Aims For US Approval Of Chemo Nausea Drug
    Shilpa Medicare Aims For US Approval Of Chemo Nausea Drug

    09 Jan 2026

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicare-aims-for-us-approval-of-chemo-nausea-drug-18815

    INDPHARMAPOST
    09 Jan 2026
    Share Share
    Shilpa Pharma Gets EU Approval For Rotigotine Transdermal Patch
    Shilpa Pharma Gets EU Approval For Rotigotine Transdermal Patch

    12 Dec 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicare-receives-initial-authorization-for-rotigotine-transdermal-patch-from-europe-18538

    INDPHARMAPOST
    12 Dec 2025
    Share Share
    Shilpa Medicare Gets 8 Observations From FDA For Jadcherla Unit 4
    Shilpa Medicare Gets 8 Observations From FDA For Jadcherla Unit 4

    24 Nov 2025

    // INDPHARMAPOST

    https://www.indianpharmapost.com/drug-approval/shilpa-medicare-receives-8-observations-from-usfda-for-unit-4-at-jadcherla-18322

    INDPHARMAPOST
    24 Nov 2025
    Share Share
    Shilpa Pharma Lifesciences Earns Ecovadis Gold For Sustainability
    Shilpa Pharma Lifesciences Earns Ecovadis Gold For Sustainability

    11 Nov 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/shilpa-pharma-lifesciences-awarded-ecovadis-gold-medal-for-outstanding-sustainability-practices-302610545.html

    PR NEWSWIRE
    11 Nov 2025
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    USDMF

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    01

    Abiraterone Acetate Usp

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    02

    Anastrozole

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    03

    Anastrozole Usp

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    04

    Axitinib

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    05

    Azacitidine

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    06

    Bendamustine Hcl

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    Bicalutamide Usp

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    08

    Bortezomib

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    09

    Bortezomib

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    NDC API

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    ABIRATERONE ACETATE

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    ABIRATERONE ACETATE

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    Shilpa Medicare

    NDC Package Code : 82920-040

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    AXITINIB

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    Shilpa Medicare

    NDC Package Code : 82920-028

    Start Marketing Date : 2022-08-15

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    03

    AZACITIDINE

    India
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    AZACITIDINE

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    Shilpa Medicare

    NDC Package Code : 82920-015

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    BENDAMUSTINE HYDROCHLORIDE

    India
    DCAT Week
    Not Confirmed
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    BENDAMUSTINE HYDROCHLORIDE

    India
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    Shilpa Medicare

    NDC Package Code : 82920-005

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    BICALUTAMIDE

    India
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    BICALUTAMIDE

    India
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    Shilpa Medicare

    NDC Package Code : 82920-004

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    BORTEZOMIB

    India
    DCAT Week
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    BORTEZOMIB

    India
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    Shilpa Medicare

    NDC Package Code : 82920-006

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1000g/1000g)

    Marketing Category : BULK INGREDIENT

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    07

    BUSULFAN

    India
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    BUSULFAN

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    Shilpa Medicare

    NDC Package Code : 82920-008

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    CAPECITABINE

    India
    DCAT Week
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    CAPECITABINE

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    Shilpa Medicare

    NDC Package Code : 82920-001

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    CLOFARABINE

    India
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    CLOFARABINE

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    Shilpa Medicare

    NDC Package Code : 82920-024

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    CYCLOPHOSPHAMIDE

    India
    DCAT Week
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    CYCLOPHOSPHAMIDE

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    Shilpa Medicare

    NDC Package Code : 82920-708

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    FDA Orange Book

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    Brand Name : APREMILAST

    India
    DCAT Week
    Not Confirmed
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    Brand Name : APREMILAST

    India
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    RLD : No

    TE Code : AB

    APREMILAST

    Shilpa Medicare

    Dosage Form : TABLET; ORAL

    Proprietary Name : APREMILAST

    Dosage Strength : 10MG

    Approval Date : 2023-04-07

    Application Number : 211774

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : APREMILAST

    India
    DCAT Week
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    RLD : No

    TE Code : AB

    APREMILAST

    Shilpa Medicare

    Dosage Form : TABLET; ORAL

    Proprietary Name : APREMILAST

    Dosage Strength : 20MG

    Approval Date : 2023-04-07

    Application Number : 211774

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    Brand Name : APREMILAST

    India
    DCAT Week
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    Brand Name : APREMILAST

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    RLD : No

    TE Code : AB

    APREMILAST

    Shilpa Medicare

    Dosage Form : TABLET; ORAL

    Proprietary Name : APREMILAST

    Dosage Strength : 30MG

    Approval Date : 2023-04-07

    Application Number : 211774

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    Brand Name : AZACITIDINE

    India
    DCAT Week
    Not Confirmed
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    Brand Name : AZACITIDINE

    India
    DCAT Week
    Not Confirmed
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    RLD : No

    TE Code : AP

    AZACITIDINE

    Shilpa Medicare

    Dosage Form : POWDER; INTRAVENOUS, SUBCUTANE...

    Proprietary Name : AZACITIDINE

    Dosage Strength : 100MG/VIAL

    Approval Date : 2016-09-29

    Application Number : 207518

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    05

    Brand Name : BORTEZOMIB

    India
    DCAT Week
    Not Confirmed
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    Brand Name : BORTEZOMIB

    India
    DCAT Week
    Not Confirmed
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    RLD : Yes

    TE Code :

    BORTEZOMIB

    Shilpa Medicare

    Dosage Form : SOLUTION; INTRAVENOUS, SUBCUTA...

    Proprietary Name : BORTEZOMIB

    Dosage Strength : 3.5MG/1.4ML (2.5MG/ML)

    Approval Date : 2024-08-26

    Application Number : 212782

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    06

    Brand Name : BUSULFAN

    India
    DCAT Week
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    Brand Name : BUSULFAN

    India
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    RLD : No

    TE Code : AP

    BUSULFAN

    Shilpa Medicare

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : BUSULFAN

    Dosage Strength : 6MG/ML

    Approval Date : 2019-04-18

    Application Number : 210931

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    07

    Brand Name : CAPECITABINE

    India
    DCAT Week
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    Brand Name : CAPECITABINE

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    RLD : No

    TE Code : AB

    CAPECITABINE

    Shilpa Medicare

    Dosage Form : TABLET; ORAL

    Proprietary Name : CAPECITABINE

    Dosage Strength : 150MG

    Approval Date : 2016-12-12

    Application Number : 207456

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    Brand Name : CAPECITABINE

    India
    DCAT Week
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    Brand Name : CAPECITABINE

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    RLD : No

    TE Code : AB

    CAPECITABINE

    Shilpa Medicare

    Dosage Form : TABLET; ORAL

    Proprietary Name : CAPECITABINE

    Dosage Strength : 500MG

    Approval Date : 2016-12-12

    Application Number : 207456

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    Brand Name : DIMETHYL FUMARATE

    India
    DCAT Week
    Not Confirmed
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    Brand Name : DIMETHYL FUMARATE

    India
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    RLD :

    TE Code :

    DIMETHYL FUMARATE

    Shilpa Medicare

    Dosage Form : CAPSULE, DELAYED RELEASE; ORAL

    Proprietary Name : DIMETHYL FUMARATE

    Dosage Strength : 120MG

    Approval Date :

    Application Number : 210291

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Brand Name : DIMETHYL FUMARATE

    India
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    RLD :

    TE Code :

    DIMETHYL FUMARATE

    Shilpa Medicare

    Dosage Form : CAPSULE, DELAYED RELEASE; ORAL

    Proprietary Name : DIMETHYL FUMARATE

    Dosage Strength : 240MG

    Approval Date :

    Application Number : 210291

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    Excipients

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    01

    Hard Capsule

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

    BIO-Europe Spring
    Not Confirmed
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    Hard Capsule

    India

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

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    BIO-Europe Spring
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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34364

    Submission : 2020-01-02

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    02

    RECOMBINANT HUMAN ALBUMIN 20%

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

    BIO-Europe Spring
    Not Confirmed
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    RECOMBINANT HUMAN ALBUMIN 20%

    India

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

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    BIO-Europe Spring
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39787

    Submission : 2024-05-31

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Shilpa Biologicals

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39787

    Submission : 2024-05-31

    Status : Active

    Type : IV

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    Contact Shilpa Medicare and get a quotation

    Shilpa Medicare is a supplier offers 85 products (APIs, Excipients or Intermediates).

    Find a price of Busulfan bulk with DMF, CEP, JDMF, WC offered by Shilpa Medicare

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    Find a price of Tranexamic Acid bulk with DMF, CEP, WC offered by Shilpa Medicare

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    Find a price of Anastrozole bulk with JDMF, WC offered by Shilpa Medicare

    Find a price of Axitinib bulk with DMF, WC offered by Shilpa Medicare

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    Find a price of Lenvatinib Mesylate bulk with DMF, WC offered by Shilpa Medicare

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    Find a price of Anastrozole bulk with DMF offered by Shilpa Medicare

    Find a price of Bortezomib bulk with DMF offered by Shilpa Medicare

    Find a price of CAS 284461-73-0 bulk with CEP offered by Shilpa Medicare

    Find a price of Desmopressin Acetate bulk with CEP offered by Shilpa Medicare

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    Find a price of Irinotecan Hydrochloride bulk with CEP offered by Shilpa Medicare

    Find a price of Melphalan Hydrochloride bulk with DMF offered by Shilpa Medicare

    Find a price of Methotrexate bulk with DMF offered by Shilpa Medicare

    Find a price of Montelukast Sodium bulk with CEP offered by Shilpa Medicare

    Find a price of Nilotinib bulk with DMF offered by Shilpa Medicare

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    Find a price of Ambroxol Hydrochloride bulk offered by Shilpa Medicare

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    Find a price of Bendamustine Hydrochloride bulk offered by Shilpa Medicare

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    Find a price of Pazopanib Hydrochloride bulk offered by Shilpa Medicare

    Find a price of Pemetrexed Disodium bulk offered by Shilpa Medicare

    Find a price of Selexipag bulk offered by Shilpa Medicare

    Find a price of Temozolomide bulk offered by Shilpa Medicare

    Find a price of Tenofovir Alafenamide bulk offered by Shilpa Medicare

    Find a price of Ursodeoxycholic Acid bulk offered by Shilpa Medicare

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