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    About

    Guardian Drug Company is a leading consumer healthcare organization that develops, manufactures and distributes pharmaceutical and nutritional products through various distribution channels from our state of the art facility located in Dayton, New Jersey. Our primary focus is to deliver quality products with great customer service at competitive prices. We are pioneers in the over-the-counter gastrointestinal products. Guardi...
    Guardian Drug Company is a leading consumer healthcare organization that develops, manufactures and distributes pharmaceutical and nutritional products through various distribution channels from our state of the art facility located in Dayton, New Jersey. Our primary focus is to deliver quality products with great customer service at competitive prices. We are pioneers in the over-the-counter gastrointestinal products. Guardian Drug Company is an approved contract manufacturer for some of the pharmaceutical majors in the country.

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    Guardian Drug CompanyUnited_States_of_America Flag
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    2 Charles Court Dayton, NJ 08810USA
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    NEWS #PharmaBuzz

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    Guardian`s Generics Potassium Chloride Receives Approval in US
    Guardian`s Generics Potassium Chloride Receives Approval in US

    11 Jul 2025

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219009

    FDA
    11 Jul 2025
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    Guardian's Generic Potassium Chloride Receives Approval in the U.S.
    Guardian's Generic Potassium Chloride Receives Approval in the U.S.

    30 Dec 2022

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214892

    FDA
    30 Dec 2022
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    Guardian Drug`s Generic Loperamide HCl;Simethicone Receives Approval in US
    Guardian Drug`s Generic Loperamide HCl;Simethicone Receives Approval in US

    30 May 2021

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214541

    FDA
    30 May 2021
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    Guardian Drug's Generic Ibuprofen Receives Approval in US
    Guardian Drug's Generic Ibuprofen Receives Approval in US

    22 Aug 2018

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210149

    FDA
    22 Aug 2018
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    Taparias to pick majority stake in Guardian pharmacy chain
    Taparias to pick majority stake in Guardian pharmacy chain

    25 Aug 2016

    // ECONOMIC TIMES

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/taparias-to-pick-majority-stake-in-guardian-pharmacy-chain/articleshow/53860234.cms

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    25 Aug 2016
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    Brand Name : FOAMCOAT

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    Regulatory Info : DISCN

    Registration Country : USA

    ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE

    Guardian Drug Company

    Dosage Form : TABLET, CHEWABLE;ORAL

    Brand Name : FOAMCOAT

    Dosage Strength : 80MG;20MG

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    Approval Date : 1987-09-04

    Application Number : 71793

    Regulatory Info : DISCN

    Registration Country : USA

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    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

    BISMUTH SUBSALICYLATE

    Guardian Drug Company

    Dosage Form : SUSPENSION

    Brand Name : BISMUTH SUBSALICYLATE SUS...

    Dosage Strength : 17.5MG/ML

    Packaging : 230ML/480ML

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    Application Number : 2313162

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    BISMUTH SUBSALICYLATE

    Guardian Drug Company

    Dosage Form : TABLET

    Brand Name : BISMUTH SUBSALICYLATE CAP...

    Dosage Strength : 262MG

    Packaging : 24

    Approval Date :

    Application Number : 2326582

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    Brand Name : EXTRA STRENGTH BISMU...

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    Regulatory Info : NON-PRESCRIPTION DRUGS

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    BISMUTH SUBSALICYLATE

    Guardian Drug Company

    Dosage Form : SUSPENSION

    Brand Name : EXTRA STRENGTH BISMUTH SU...

    Dosage Strength : 35MG/ML

    Packaging : 236/350/473ML

    Approval Date :

    Application Number : 2328453

    Regulatory Info : NON-PRESCRIPTION DRUGS

    Registration Country : Canada

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    Brand Name : STOMACH RELIEF CHEWA...

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    Regulatory Info : NON-PRESCRIPTION DRUGS

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    BISMUTH SUBSALICYLATE

    Guardian Drug Company

    Dosage Form : TABLET (CHEWABLE)

    Brand Name : STOMACH RELIEF CHEWABLE T...

    Dosage Strength : 262MG

    Packaging : 24/48

    Approval Date :

    Application Number : 2389215

    Regulatory Info : NON-PRESCRIPTION DRUGS

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    Regulatory Info : NON-PRESCRIPTION DRUGS

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    CALCIUM CARBONATE

    Guardian Drug Company

    Dosage Form : TABLET (CHEWABLE)

    Brand Name : STOMACH RELIEF CHEWABLE T...

    Dosage Strength : 350MG

    Packaging : 24/48

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    Application Number : 2389215

    Regulatory Info : NON-PRESCRIPTION DRUGS

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    Brand Name : ESOMEPRAZOLE MAGNESI...

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    Regulatory Info : OTC

    Registration Country : USA

    ESOMEPRAZOLE MAGNESIUM

    Guardian Drug Company

    Dosage Form : CAPSULE, DELAYED RELEASE...

    Brand Name : ESOMEPRAZOLE MAGNESIUM

    Dosage Strength : EQ 20MG BASE

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    Approval Date : 2023-03-15

    Application Number : 216149

    Regulatory Info : OTC

    Registration Country : USA

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    Brand Name : GUAIFENESIN

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    Regulatory Info : OTC

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    GUAIFENESIN

    Guardian Drug Company

    Dosage Form : TABLET, EXTENDED RELEASE...

    Brand Name : GUAIFENESIN

    Dosage Strength : 600MG

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    Approval Date : 2017-09-06

    Application Number : 209215

    Regulatory Info : OTC

    Registration Country : USA

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    GUAIFENESIN

    Guardian Drug Company

    Dosage Form : TABLET, EXTENDED RELEASE...

    Brand Name : GUAIFENESIN

    Dosage Strength : 1.2GM

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    Approval Date : 2017-09-06

    Application Number : 209215

    Regulatory Info : OTC

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    Regulatory Info : OTC

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    IBUPROFEN

    Guardian Drug Company

    Dosage Form : SUSPENSION;ORAL

    Brand Name : IBUPROFEN

    Dosage Strength : 100MG/5ML

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    Approval Date : 2018-08-17

    Application Number : 210149

    Regulatory Info : OTC

    Registration Country : USA

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    District Decision : No Action Indicated

    Inspection End Date : 2024-11-07

    Guardian Drug Company

    City : Dayton

    State : New Jersey

    Country/Area : U.S.A

    Zip : 8810

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    Center :

    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2024-11-07

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-02-17

    Guardian Drug Company

    City : Dayton

    State : New Jersey

    Country/Area : U.S.A

    Zip : 8810

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-02-17

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-11-06

    Guardian Drug Company

    City : Dayton

    State : New Jersey

    Country/Area : U.S.A

    Zip : 8810

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-11-06

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    District Decision : No Action Indicated

    Inspection End Date : 2014-08-15

    Guardian Drug Company

    City : Dayton

    State : NJ

    Country/Area : U.S.A

    Zip : 08810-1508

    District : NWJ

    Center : CFSAN

    Project Area : Food Composition, Standards, Lab...

    District Decision : No Action Indicated

    Inspection End Date : 2014-08-15

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    District Decision : No Action Indicated

    Inspection End Date : 2014-08-15

    Guardian Drug Company

    City : Dayton

    State : New Jersey

    Country/Area : U.S.A

    Zip : 8810

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    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-08-15

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-08

    Guardian Drug Company

    City : Dayton

    State : NJ

    Country/Area : U.S.A

    Zip : 08810-1508

    District : NWJ

    Center : CFSAN

    Project Area : Food Composition, Standards, Lab...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-08

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-08

    Guardian Drug Company

    City : Dayton

    State : New Jersey

    Country/Area : U.S.A

    Zip : 8810

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-06-08

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-03-02

    Guardian Drug Company

    City : Dayton

    State : New Jersey

    Country/Area : U.S.A

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2011-02-18

    Guardian Drug Company

    City : Dayton

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    Inspection End Date : 2011-02-18

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2008-10-28

    Guardian Drug Company

    City : Dayton

    State : New Jersey

    Country/Area : U.S.A

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2008-10-28

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    Paid in : 2019

    Guardian Drug Company

    API Manufacturer :

    FDF Manufacturer : FDF MANUFACTURE

    Facility Name : Guardian Drug Company Inc.

    Business Address : 2 Charles court Dayton NJ 08...

    FEI Number : 2245306

    Country : U.S.A

    Paid in : 2019

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