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    Company profile for Bionpharma

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    About

    Bionpharma, which began in late 2014, is a pharmaceutical company backed and built by seasoned professionals in the Global Generics business with cumulative experience of more than 100 years. Based out of Princeton, New Jersey and with offices in Raleigh, North Carolina, Bionpharma is licensed to do business in all the US states and is accomplished in the areas of Product Development, Regulatory Affairs, Quality management, Sa...
    Bionpharma, which began in late 2014, is a pharmaceutical company backed and built by seasoned professionals in the Global Generics business with cumulative experience of more than 100 years. Based out of Princeton, New Jersey and with offices in Raleigh, North Carolina, Bionpharma is licensed to do business in all the US states and is accomplished in the areas of Product Development, Regulatory Affairs, Quality management, Sales and Distribution and Supply Chain management.

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    CONTACT DETAILS

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    BionpharmaUnited_States_of_America Flag
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    Country
    U.S.A
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    Address
    Suite 2-4B, 600 Alexander Road, Princeton, NJ 08540
    Telephone
    Telephone
    6093803310
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    http://www.bionpharma.com/index.html
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    Events

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    IPhEB Russia

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    NEWS #PharmaBuzz

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    Bionpharma Gets USFDA Nod For Etravirine Tablets With Steerlife
    Bionpharma Gets USFDA Nod For Etravirine Tablets With Steerlife

    13 Jan 2026

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/bionpharma-inc-receives-usfda-approval-for-etravirine-tablets-developed-in-collaboration-with-steerlife-302659657.html

    PR NEWSWIRE
    13 Jan 2026
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    Bionpharma’s Generics Etravirine Receives Approval in US
    Bionpharma’s Generics Etravirine Receives Approval in US

    02 Oct 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219152

    FDA
    02 Oct 2025
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    Bionpharma Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension
    Bionpharma Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension

    18 Sep 2024

    // FDA

    https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial

    FDA
    18 Sep 2024
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    Bionpharma's Generic Magnesium Sulfate Receives Approval in US
    Bionpharma's Generic Magnesium Sulfate Receives Approval in US

    24 Jun 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204135

    FDA
    24 Jun 2024
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    Bionpharma's Generic Loratadine;Pseudoephedrine Receives Approval in the U.S.
    Bionpharma's Generic Loratadine;Pseudoephedrine Receives Approval in the U.S.

    14 May 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218017

    FDA
    14 May 2024
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    Bionpharma's Generic Fluvoxamine Maleate Receives Approval in the U.S.
    Bionpharma's Generic Fluvoxamine Maleate Receives Approval in the U.S.

    22 Jan 2024

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217917

    FDA
    22 Jan 2024
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    ALL APIs

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    read-moreClick the button for full data set

    01

    Dapagliflozin

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

    Health 2.0 Conference
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    Dapagliflozin

    U.S.A

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

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-10-05

    Pay. Date : 2017-08-30

    DMF Number : 32036

    Submission : 2017-09-01

    Status : Active

    Type : II

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

    Ivabradine Hydrochloride

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

    Health 2.0 Conference
    Not Confirmed
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    Ivabradine Hydrochloride

    U.S.A

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

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    Health 2.0 Conference
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-11-05

    Pay. Date : 2018-09-21

    DMF Number : 33077

    Submission : 2018-09-21

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Drugs in Development

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    Bionpharma Gets USFDA Nod for Etravirine Tablets with STEERLife

    Details:

    Etravirine, a miscellaneous product, targets human immunodeficiency virus type 1 reverse transcriptase, focusing on treating HIV/AIDS.


    Lead Product(s): Etravirine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Intelence-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: STEERLife India Pvt. Ltd

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 13, 2026

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    01

    Bionpharma

    U.S.A
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    Bionpharma

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    Lead Product(s) : Etravirine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : STEERLife India Pvt. Ltd

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bionpharma Gets USFDA Nod for Etravirine Tablets with STEERLife

    Details : Etravirine, a miscellaneous product, targets human immunodeficiency virus type 1 reverse transcriptase, focusing on treating HIV/AIDS.

    Product Name : Intelence-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 13, 2026

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    FDF Dossiers

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    01

    Brand Name : ACAMPROSATE CALCIUM

    U.S.A
    IPhEB Russia
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    Brand Name : ACAMPROSATE CALCIUM

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    ACAMPROSATE CALCIUM

    Bionpharma

    Dosage Form : TABLET, DELAYED RELEASE;...

    Brand Name : ACAMPROSATE CALCIUM

    Dosage Strength : 333MG

    Packaging :

    Approval Date : 2025-09-18

    Application Number : 219904

    Regulatory Info : RX

    Registration Country : USA

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    02

    Brand Name : ACETAMINOPHEN AND IB...

    U.S.A
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    Brand Name : ACETAMINOPHEN AND IB...

    U.S.A
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    IPhEB Russia
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    Regulatory Info : OTC

    Registration Country : USA

    ACETAMINOPHEN; IBUPROFEN

    Bionpharma

    Dosage Form : TABLET;ORAL

    Brand Name : ACETAMINOPHEN AND IBUPROF...

    Dosage Strength : 250MG;125MG

    Packaging :

    Approval Date : 2023-08-01

    Application Number : 216999

    Regulatory Info : OTC

    Registration Country : USA

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    03

    Brand Name : AMANTADINE HYDROCHLO...

    U.S.A
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    Brand Name : AMANTADINE HYDROCHLO...

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    AMANTADINE HYDROCHLORIDE

    Bionpharma

    Dosage Form : CAPSULE;ORAL

    Brand Name : AMANTADINE HYDROCHLORIDE

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2008-05-29

    Application Number : 78720

    Regulatory Info : RX

    Registration Country : USA

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    04

    Brand Name : AMPHETAMINE SULFATE

    U.S.A
    IPhEB Russia
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    Brand Name : AMPHETAMINE SULFATE

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    AMPHETAMINE SULFATE

    Bionpharma

    Dosage Form : TABLET;ORAL

    Brand Name : AMPHETAMINE SULFATE

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2019-11-22

    Application Number : 212919

    Regulatory Info : RX

    Registration Country : USA

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    05

    Brand Name : AMPHETAMINE SULFATE

    U.S.A
    IPhEB Russia
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    Brand Name : AMPHETAMINE SULFATE

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    AMPHETAMINE SULFATE

    Bionpharma

    Dosage Form : TABLET;ORAL

    Brand Name : AMPHETAMINE SULFATE

    Dosage Strength : 10MG

    Packaging :

    Approval Date : 2019-11-22

    Application Number : 212919

    Regulatory Info : RX

    Registration Country : USA

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    06

    Brand Name : APIXABAN

    U.S.A
    IPhEB Russia
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    Brand Name : APIXABAN

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    APIXABAN

    Bionpharma

    Dosage Form : TABLET;ORAL

    Brand Name : APIXABAN

    Dosage Strength : 2.5MG

    Packaging :

    Approval Date : 2020-04-08

    Application Number : 210152

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Brand Name : APIXABAN

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    APIXABAN

    Bionpharma

    Dosage Form : TABLET;ORAL

    Brand Name : APIXABAN

    Dosage Strength : 5MG

    Packaging :

    Approval Date : 2020-04-08

    Application Number : 210152

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Brand Name : ATOVAQUONE

    U.S.A
    IPhEB Russia
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    Brand Name : ATOVAQUONE

    U.S.A
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    Regulatory Info : RX

    Registration Country : USA

    ATOVAQUONE

    Bionpharma

    Dosage Form : SUSPENSION;ORAL

    Brand Name : ATOVAQUONE

    Dosage Strength : 750MG/5ML

    Packaging :

    Approval Date : 2021-03-30

    Application Number : 212918

    Regulatory Info : RX

    Registration Country : USA

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    09

    Brand Name : AZELASTINE HYDROCHLO...

    U.S.A
    IPhEB Russia
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    Brand Name : AZELASTINE HYDROCHLO...

    U.S.A
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    Regulatory Info : DISCN

    Registration Country : USA

    AZELASTINE HYDROCHLORIDE

    Bionpharma

    Dosage Form : SPRAY, METERED;NASAL

    Brand Name : AZELASTINE HYDROCHLORIDE

    Dosage Strength : 0.137MG/SPRAY

    Packaging :

    Approval Date : 2015-07-28

    Application Number : 90176

    Regulatory Info : DISCN

    Registration Country : USA

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    10

    Brand Name : AZITHROMYCIN

    U.S.A
    IPhEB Russia
    Not Confirmed
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    Brand Name : AZITHROMYCIN

    U.S.A
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    IPhEB Russia
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    Regulatory Info : RX

    Registration Country : USA

    AZITHROMYCIN

    Bionpharma

    Dosage Form : TABLET;ORAL

    Brand Name : AZITHROMYCIN

    Dosage Strength : EQ 600MG BASE

    Packaging :

    Approval Date : 2018-12-26

    Application Number : 209999

    Regulatory Info : RX

    Registration Country : USA

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    ABOUT THIS PAGE

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    Bionpharma is a supplier offers 2 products (APIs, Excipients or Intermediates).

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