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    • NOVEMBER 16, 2021
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    THE FDA HAS OFFICIALLY REMOVED ZHEJIANG HUAHAI PHARMACEUTICAL FROM IMPORT ALERT

    THE FDA HAS OFFICIALLY REMOVED ZHEJIANG HUAHAI PHARMACEUTICAL FROM IMPORT ALERT

    THE FDA HAS OFFICIALLY REMOVED ZHEJIANG HUAHAI PHARMACEUTICAL FROM IMPORT ALERT Somerset, NJ, November 15, 2021 – Solco is pleased to announce that the FDA has lifted the ImportAlert (IA) 66-40, “Detention Without Physical Examination of Drugs From Firms Which Have Not MetDrug GMPs”, Published Date: 11/12/2021, from Zhejiang Huahai Pharmaceutical Co. Ltd., at CoastalIndustrial

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    • 2021,
    • Solco News
    • APRIL 17, 2020
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    SOLCO HEALTHCARE US, RECEIVES FDA APPROVAL FOR AMPHETAMINE SULFATE Tablets, 5mg and 10mg

    SOLCO HEALTHCARE US, RECEIVES FDA APPROVAL FOR AMPHETAMINE SULFATE Tablets, 5mg and 10mg

    SOMERSET, NJ — Solco Healthcare announces its FDA approval for Amphetamine Sulfate tablets, 5mg and 10mg, which is an AA-rated equivalent to Evekeo® by Arbor Pharmaceuticals. “This approval represents Solco’s first CII product within the ADHD therapeutic treatment. Amphetamine sulfate tablets will be manufactured in our Prinston Laboratories facility located in Charlotte, NC. We are

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    • 2020,
    • Solco News
    • MAY 23, 2019
    • 1 COMMENT
    SOLCO HEALTHCARE US, RECEIVES FDA APPROVAL FOR GLYCOPYRROLATE INJECTION, 0.2 mg/mL

    SOLCO HEALTHCARE US, RECEIVES FDA APPROVAL FOR GLYCOPYRROLATE INJECTION, 0.2 mg/mL

    SOLCO HEALTHCARE US, RECEIVES FDA APPROVAL FOR GLYCOPYRROLATE INJECTION, 0.2 mg/mL CRANBURY, NJ — Solco Healthcare announces its FDA approval for Glycopyrrolate Injection, 0.2mg/mL, which is an AP-rated equivalent to Robinul® by Hikma. “We are very pleased to have received FDA approval for Glycopyrrolate injection.  This approval represents a new chapter for Solco, as we enter

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    • 2019,
    • Solco News
    • JANUARY 18, 2019
    • 0 COMMENTS
    Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, Nnitrosodiethylamine (NDEA) in the Products

    Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, Nnitrosodiethylamine (NDEA) in the Products

    Read PDF here. http://www.solcohealthcare.com/uploads/news/Press-Release-Irbesartan-Recall.pdf

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    • Recall Information
    • DECEMBER 14, 2018
    • 0 COMMENTS
    Press Release – Dec. 14, 2018

    Press Release – Dec. 14, 2018

    FOR IMMEDIATE RELEASE – CRANBURY, NEW JERSEY –  December 14, 2018 On July 12, 2018, Prinston Pharmaceutical Inc. announced that one of its affiliated companies, Solco Healthcare, LLC, based in Cranbury, New Jersey, voluntarily recalled all lots of Valsartan Tablets, 40mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5g, 160mg/25mg, 320mg/12.5mg and 320mg/25mg, to the consumer

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    • Recall Information
    • AUGUST 21, 2018
    • 0 COMMENTS
    Press Release – Update on Valsartan API – A Statement from the Company

    Press Release – Update on Valsartan API – A Statement from the Company

    FOR IMMEDIATE RELEASE – CRANBURY, NEW JERSEY, August 21, 2018. Huahai US Inc., a subsidiary of Zhejiang Huahai Pharmaceutical Co. Ltd is issuing a statement. Recent articles in several print and on-line media have misrepresented information about the discovery of a trace amount of a genotoxic impurity in Valsartan, an active pharmaceutical ingredient (API) made

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    • 2018,
    • Solco News
    • JULY 13, 2018
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    Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA) in the Products

    Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N-nitrosodimethylamine (NDMA) in the Products

    Read detail here: http://www.solcohealthcare.com/uploads/news/PressReleaseValsartanRecallFinal.pdf

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    • Recall Information
    • JUNE 18, 2018
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    SOLCO HEALTHCARE US ANNOUNCES THE FDA APPROVAL OF FENOFIBRATE TABLETS, 48mg and 145mg

    SOLCO HEALTHCARE US ANNOUNCES THE FDA APPROVAL OF FENOFIBRATE TABLETS, 48mg and 145mg

    CRANBURY, NJ — Solco Healthcare is proud to announce its FDA approval for Fenofibrate tablets, 48 mg and 145 mg, which is an AB-rated equivalent to Tricor® by Abbvie. Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to

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    • 2018,
    • Solco News
    • APRIL 25, 2018
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    SOLCO HEALTHCARE US ANNOUNCES THE LAUNCH OF ENTECAVIR TABLETS

    SOLCO HEALTHCARE US ANNOUNCES THE LAUNCH OF ENTECAVIR TABLETS

    CRANBURY, NJ., April 25, 2018 – Solco Healthcare is proud to announce the launch of Entecavir Tablets, 0.5mg and 1mg, a generic equivalent of Baraclude® Tablets by Bristol-Myers Squibb Company.  Solco is offering Entecavir Tablets, 0.5mg and 1mg, in 30-count bottles to its customers. The product is available for shipment immediately.  Entecavir tablets are used to treat chronic

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    • 2018,
    • Solco News
    • APRIL 3, 2018
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    SOLCO HEALTHCARE US ANNOUNCES THE LAUNCH OF CLONIDINE HCL ER TABLETS

    SOLCO HEALTHCARE US ANNOUNCES THE LAUNCH OF CLONIDINE HCL ER TABLETS

    Cranbury, NJ., April 3, 2018.  Solco Healthcare announced today the launch of Clonidine Hydrochloride Extended-Release Tablets, 01.mg, a generic version of Kapvay® Tablets by Concordia Pharmaceuticals Inc.  The product is used for the treatment of attention-deficit/hyperactivity disorder (ADHD). The U.S. Food and Drug Administration (FDA) has granted final approval of its Abbreviated New Drug Application for Clonidine

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    • 2018,
    • Solco News
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