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    Company profile for Istituto Biochimico Italiano Giovanni Lorenzini SpA

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    About

    Ibi was founded in 1918 by Professor Giovanni Lorenzini. A long tradition in the field of scientific research together with the innovative technologies applied and the level of care and attention to production have given Ibi its reputation for reliability and high quality. The Ibi plant covers an area of 18,000 square metres, on which a new building is entirely dedicated to the production of ß-lactamics. Offering state of the...
    Ibi was founded in 1918 by Professor Giovanni Lorenzini. A long tradition in the field of scientific research together with the innovative technologies applied and the level of care and attention to production have given Ibi its reputation for reliability and high quality. The Ibi plant covers an area of 18,000 square metres, on which a new building is entirely dedicated to the production of ß-lactamics. Offering state of the art service and technology, Ibi is among the top ten Italian companies in toll manufacturing. Today Ibi is present in over 30 countries, exporting two thirds of its total production. It is one of few companies not producing in the United States that has obtained FDA approval for the production of sterile penicillin for the American market. Ibi has developed a new distribution strategy directly to hospitals, entrusting the sales of its products to a special new organization, Ibisqus, created in joint venture and present in the UK, Germany and Italy. Ibi is present on the Italian market with a variety of products ranging from sterile penicillin to food supplements. It is well known for the reputation of its products in the area of antinfective therapy and gastroenterology. A network of highly qualified scientific informers enables Ibi to contact the universe of gastroenterologist specialist and 55% of infectious disase specialist. Ibi provides directly 4000 pharmacies. In addition to its tradition and quality, today Ibi is proud of its innovative laboratories and expert researchers, able to offer new services in the fields of Biotechnology and Nano-medicine, especially in the development of processes for the production of recombinant proteins in cGMP and in the planning and production of new delivery systems. Years of experience in formulation studies, in the development of production processes and in industrial scale-up enable Ibi to face the new challenges on the pharmaceutical market with confidence. Ibi produces its products in conformity with the regulations of the European Pharmacopoeia and the cGMP norms. It is, in addition, certified by the most demanding Health Authorities: AIFA, FDA, TGA and MCA.

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    Istituto Biochimico Italiano Giovanni Lorenzini SpAItaly Flag
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    Italy
    Address
    Address
    Istituto Biochimico Italiano Giovanni Lorenzini S.p.a. Via Fossignano 2, 04011...
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    Telephone
    +39.06.92150.1
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    enquiries@pharmacompass.com
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    Website
    https://www.ibi-lorenzini.it/it
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    Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. Fail EDQM Inspection
    Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. Fail EDQM Inspection

    04 Aug 2023

    // EDQM

    https://www.pharmacompass.com/pdf/news/istituto-biochimico-italiano-giovanni-lorenzini-spa-fail-edqm-inspection-48757.pdf

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    04 Aug 2023
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    FDA Orange Book

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    Brand Name : AMPICILLIN SODIUM

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 250MG BASE/VIAL

    Approval Date : 1987-05-12

    Application Number : 62719

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 1GM BASE/VIAL

    Approval Date : 1987-05-12

    Application Number : 62719

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 500MG BASE/VIAL

    Approval Date : 1987-05-12

    Application Number : 62719

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code :

    AMPICILLIN SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 125MG BASE/VIAL

    Approval Date : 1993-07-12

    Application Number : 62797

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 2GM BASE/VIAL

    Approval Date : 1993-07-12

    Application Number : 62797

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN SODIUM

    Dosage Strength : EQ 10GM BASE/VIAL

    Approval Date : 2013-12-20

    Application Number : 201404

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Brand Name : AMPICILLIN AND SULBA...

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM; SULBACTAM SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN AND SULBACTAM

    Dosage Strength : EQ 1GM BASE/VIAL;EQ 500M...

    Approval Date : 2005-11-29

    Application Number : 65222

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM; SULBACTAM SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN AND SULBACTAM

    Dosage Strength : EQ 2GM BASE/VIAL;EQ 1GM ...

    Approval Date : 2005-11-29

    Application Number : 65222

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    RLD : No

    TE Code : AP

    AMPICILLIN SODIUM; SULBACTAM SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : AMPICILLIN AND SULBACTAM

    Dosage Strength : EQ 10GM BASE/VIAL;EQ 5GM...

    Approval Date : 2006-11-27

    Application Number : 65314

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Brand Name : NAFCILLIN SODIUM

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    RLD : No

    TE Code : AP

    NAFCILLIN SODIUM

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : NAFCILLIN SODIUM

    Dosage Strength : EQ 1GM BASE/VIAL

    Approval Date : 2011-06-30

    Application Number : 90002

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Inspections and registrations

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    FDA

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-11-21

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

    State :

    Country/Area : Italy

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    Project Area : Bioresearch Monitoring

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2024-11-21

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-09-19

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

    State :

    Country/Area : Italy

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-09-19

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-21

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-02-21

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-07-17

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-07-17

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    District Decision : Official Action Indicated

    Inspection End Date : 2017-07-04

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

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    Project Area : Drug Quality Assurance

    District Decision : Official Action Indicated

    Inspection End Date : 2017-07-04

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-03-03

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-03-03

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-10-05

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-10-05

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-10-30

    Istituto Biochimico Italiano Giovanni Lorenzini SpA

    City : Aprilia

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    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-10-30

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