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    Company profile for F. Hoffmann-La Roche

    Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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    Global Pharma Healthcare: Setting the global benchmark in quality, innovation, and care

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    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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    Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

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    Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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    pharmacompass-2-m-2025-11-03

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    EVENTS

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    ACTIVE PHARMA INGREDIENTS

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    About

    We are known for pharmaceutical medicines since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally. Roche was one of the first companies to bring targeted treatments to patients. With our combined strength in pharmaceuticals and diagnostics, we are better equipped than any other company to further drive personalised healt...
    We are known for pharmaceutical medicines since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally. Roche was one of the first companies to bring targeted treatments to patients. With our combined strength in pharmaceuticals and diagnostics, we are better equipped than any other company to further drive personalised healthcare.

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    CONTACT DETAILS

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    F. Hoffmann-La RocheSwitzerland Flag
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    Switzerland
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    Konzern-Hauptsitz Grenzacherstrasse 124 CH-4070 Basel
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    +41-61-688 1111
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    enquiries@pharmacompass.com
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    https://www.roche.com/
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    NEWS #PharmaBuzz

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    Roche Commits $100M To Keep Its GLP-1 Structure Sound
    Roche Commits $100M To Keep Its GLP-1 Structure Sound

    06 Jan 2026

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/roche-shores-100m-keep-its-glp-1-structure-sound

    FIERCE BIOTECH
    06 Jan 2026
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    FDA Approves Roche's Lunsumio VELO For Subcutaneous Use
    FDA Approves Roche's Lunsumio VELO For Subcutaneous Use

    22 Dec 2025

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2025/12/22/3208933/0/en/FDA-approves-Roche-s-Lunsumio-VELO-for-subcutaneous-use-in-relapsed-or-refractory-follicular-lymphoma.html

    GLOBENEWSWIRE
    22 Dec 2025
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    Roche CEO Points to Higher Future Drug Prices in Switzerland
    Roche CEO Points to Higher Future Drug Prices in Switzerland

    20 Dec 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/roche-ceo-points-higher-future-drug-prices-switzerland-after-us-deal-2025-12-20/

    REUTERS
    20 Dec 2025
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    Caris, Genentech Collaborate on Novel Cancer Targets
    Caris, Genentech Collaborate on Novel Cancer Targets

    16 Dec 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/caris-life-sciences-announces-collaboration-with-genentech-to-discover-novel-therapeutic-targets-in-cancers-with-high-unmet-clinical-need-302642859.html

    PR NEWSWIRE
    16 Dec 2025
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    Roche Launches Next-Gen Cobas 6800/8800 in U.S
    Roche Launches Next-Gen Cobas 6800/8800 in U.S

    16 Dec 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/roche-announces-us-launch-of-next-generation-cobas-68008800-systems-and-software-enhancing-laboratory-efficiency-and-testing-capabilities-302642738.html

    PR NEWSWIRE
    16 Dec 2025
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    FDA Approves Roche's ENHERTU for HER2+ Metastatic Breast Cancer
    FDA Approves Roche's ENHERTU for HER2+ Metastatic Breast Cancer

    16 Dec 2025

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-first-diagnostic-tests-to-identify-her2-positive-metastatic-breast-cancer-patients-eligible-for-enhertu-302642587.html

    PR NEWSWIRE
    16 Dec 2025
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    Drugs in Development

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    Koru Medical Systems Submits 510(k) for FreedomEDGE® System with Oncology Biologic

    Details:

    Pertuzumab, an unconjugated antibody targeting HER2, shows promising results in treating HER2 breast cancer.


    Lead Product(s): Pertuzumab,Trastuzumab,Hyaluronidase

    Therapeutic Area: Oncology Brand Name: Phesgo

    Study Phase: Approved FDFProduct Type: Antibody, Unconjugated

    Recipient: KORU Medical Systems

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 30, 2025

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    Lead Product(s) : Pertuzumab,Trastuzumab,Hyaluronidase

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Recipient : KORU Medical Systems

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Koru Medical Systems Submits 510(k) for FreedomEDGE® System with Oncology Biologic

    Details : Pertuzumab, an unconjugated antibody targeting HER2, shows promising results in treating HER2 breast cancer.

    Product Name : Phesgo

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    December 30, 2025

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    A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Seve...

    Details:

    RO7790121 (Afimkibart) is a antibody drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Crohn Disease.


    Lead Product(s): Afimkibart

    Therapeutic Area: Immunology Brand Name: RO7790121

    Study Phase: Phase IIIProduct Type: Antibody, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 23, 2025

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    F. Hoffmann-La Roche

    Switzerland
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    Lead Product(s) : Afimkibart

    Therapeutic Area : Immunology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and M...

    Details : RO7790121 (Afimkibart) is a antibody drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Crohn Disease.

    Product Name : RO7790121

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    December 23, 2025

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    A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

    Details:

    Inavolisib is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Prostatic Neoplasms.


    Lead Product(s): Inavolisib,Enzalutamide,FoundationOne® CDx (F1CDx) Assay

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 17, 2025

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    F. Hoffmann-La Roche

    Switzerland
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    Lead Product(s) : Inavolisib,Enzalutamide,FoundationOne® CDx (F1CDx) Assay

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate...

    Details : Inavolisib is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Prostatic Neoplasms.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 17, 2025

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    Caris, Genentech Collaborate on Novel Cancer Therapeutic Targets

    Details:

    The collaboration aims to advance oncology research through the development of an undisclosed lead product.


    Lead Product(s): Undisclosed

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Discovery PlatformProduct Type: Undisclosed

    Recipient: Caris Life Sciences

    Deal Size: $1,125.0 million Upfront Cash: $25.0 million

    Deal Type: Collaboration December 16, 2025

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    Genentech

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    Lead Product(s) : Undisclosed

    Therapeutic Area : Oncology

    Highest Development Status : Discovery Platform

    Recipient : Caris Life Sciences

    Deal Size : $1,125.0 million

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Caris, Genentech Collaborate on Novel Cancer Therapeutic Targets

    Details : The collaboration aims to advance oncology research through the development of an undisclosed lead product.

    Product Name : Undisclosed

    Product Type : Undisclosed

    Upfront Cash : $25.0 million

    December 16, 2025

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    A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Pro...

    Details:

    RO7268489 is currently being evaluated in Phase II clinical studies for the treatment of Multiple Sclerosis.


    Lead Product(s): RO7268489,Ocrelizumab

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Undisclosed

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 15, 2025

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    F. Hoffmann-La Roche

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    Lead Product(s) : RO7268489,Ocrelizumab

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as A...

    Details : RO7268489 is currently being evaluated in Phase II clinical studies for the treatment of Multiple Sclerosis.

    Product Name : Undisclosed

    Product Type : Undisclosed

    Upfront Cash : Inapplicable

    December 15, 2025

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    A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants

    Details:

    RO7806881 is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies.


    Lead Product(s): RO7806881

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 09, 2025

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    F. Hoffmann-La Roche

    Switzerland
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    Lead Product(s) : RO7806881

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881...

    Details : RO7806881 is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 09, 2025

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    Orano Med Advances Collaboration With Roche

    Details:

    The collaboration aims to advance an antibody for colorectal cancer.


    Lead Product(s): Undisclosed,Lead-212

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Antibody, Unconjugated

    Recipient: Oranomed

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration December 04, 2025

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    F. Hoffmann-La Roche

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    Lead Product(s) : Undisclosed,Lead-212

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Recipient : Oranomed

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Orano Med Advances Collaboration With Roche

    Details : The collaboration aims to advance an antibody for colorectal cancer.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Undisclosed

    December 04, 2025

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    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease

    Details:

    RG6496 is a oligonucleotide drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Huntington Disease.


    Lead Product(s): RG6496

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Oligonucleotide

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 24, 2025

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    F. Hoffmann-La Roche

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    Lead Product(s) : RG6496

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in ...

    Details : RG6496 is a oligonucleotide drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Huntington Disease.

    Product Name : Undisclosed

    Product Type : Oligonucleotide

    Upfront Cash : Inapplicable

    November 24, 2025

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    Phase II Study of DONQ52 in Active Celiac Disease

    Details:

    DONQ52 is an antibody candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Celiac Disease.


    Lead Product(s): DONQ52,Simulated Inadvertent Gluten Exposure Capsule

    Therapeutic Area: Gastroenterology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Antibody, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 20, 2025

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    09

    Chugai Pharmaceutical

    Japan
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    Chugai Pharmaceutical

    Japan
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    Lead Product(s) : DONQ52,Simulated Inadvertent Gluten Exposure Capsule

    Therapeutic Area : Gastroenterology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Phase II Study of DONQ52 in Active Celiac Disease

    Details : DONQ52 is an antibody candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Celiac Disease.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    November 20, 2025

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    A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's ...

    Details:

    RO7812653 is an antibody candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Alzheimer Disease.


    Lead Product(s): RO7812653

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Antibody, Unconjugated

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 19, 2025

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    F. Hoffmann-La Roche

    Switzerland
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    Lead Product(s) : RO7812653

    Therapeutic Area : Neurology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO78126...

    Details : RO7812653 is an antibody candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Alzheimer Disease.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    November 19, 2025

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    Excipients

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    REF. STANDARDS & IMPURITIES

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    Inspections and registrations

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    FDA

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    FDA Audited

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    FDA Audited

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    BIO Partnering at JPM
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    District Decision : No Action Indicated

    Inspection End Date : 2017-07-12

    Genentech

    City : South San Francisco

    State : CA

    Country/Area : U.S.A

    Zip : 94080-4990

    District : SAN

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : No Action Indicated

    Inspection End Date : 2017-07-12

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    FDA Audited

    USA
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    FDA Audited

    USA
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    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-28

    Genentech

    City : Vacaville

    State : CA

    Country/Area : U.S.A

    Zip : 95688-9431

    District : SAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2015-08-28

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    FDA Audited

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    FDA Audited

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    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-21

    Genentech

    City : Oceanside

    State : CA

    Country/Area : U.S.A

    Zip : 92056-5701

    District : LOS

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-21

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    District Decision : No Action Indicated

    Inspection End Date : 2015-05-15

    Genentech

    City : South San Francisco

    State : CA

    Country/Area : U.S.A

    Zip : 94080-4990

    District : SAN

    Center : CDER

    Project Area : Bioresearch Monitoring

    District Decision : No Action Indicated

    Inspection End Date : 2015-05-15

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    05

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    FDA Audited

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    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-12-19

    F. Hoffmann-La Roche

    City : Florence

    State : SC

    Country/Area : U.S.A

    Zip : 29506-9330

    District : ATL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-12-19

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    06

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    Not Confirmed
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    FDA Audited

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    BIO Partnering at JPM
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    District Decision : No Action Indicated

    Inspection End Date : 2014-07-01

    Genentech

    City : Hillsboro

    State : OR

    Country/Area : U.S.A

    Zip : 97124-5301

    District : SEA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-07-01

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    07

    FDA Audited

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    Not Confirmed
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    FDA Audited

    USA
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    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-02

    Genentech

    City : South San Francisco

    State : CA

    Country/Area : U.S.A

    Zip : 94080-4990

    District : SAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-02

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    08

    FDA Audited

    USA
    BIO Partnering at JPM
    Not Confirmed
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    FDA Audited

    USA
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    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-02-21

    Genentech

    City : South San Francisco

    State : CA

    Country/Area : U.S.A

    Zip : 94080-4990

    District : SAN

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-02-21

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    09

    FDA Audited

    USA
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    Not Confirmed
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    FDA Audited

    USA
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    BIO Partnering at JPM
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-02-21

    Genentech

    City : South San Francisco

    State : CA

    Country/Area : U.S.A

    Zip : 94080-4990

    District : SAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-02-21

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    10

    FDA Audited

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    BIO Partnering at JPM
    Not Confirmed
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    FDA Audited

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    BIO Partnering at JPM
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-09-06

    Genentech

    City : Vacaville

    State : CA

    Country/Area : U.S.A

    Zip : 95688-9431

    District : SAN

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-09-06

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    EDQM

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    GMP Certified

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    GMP Certified

    EU
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    BIO Partnering at JPM
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    Genentech

    Type : GMP Certificates

    Number : NL/H 14/100...

    EudraGMDP Key : 24418

    Country : U.S.A

    Issue Date :

    Post Code : OR 97124

    NCA Ref : 2.4418139626...

    City : Hillsboro

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    02

    GMP Certified

    EU
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    GMP Certified

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    BIO Partnering at JPM
    Not Confirmed

    Genentech

    Type : GMP Certificates

    Number : DK H 000231...

    EudraGMDP Key : 12056

    Country : U.S.A

    Issue Date :

    Post Code : CA 95688

    NCA Ref : 253078

    City : Vacaville

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    03

    GMP Certified

    EU
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    GMP Certified

    EU
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    BIO Partnering at JPM
    Not Confirmed

    Genentech

    Type : GMP Certificates

    Number : DK H 000231...

    EudraGMDP Key : 12056

    Country : U.S.A

    Issue Date :

    Post Code : CA 95688

    NCA Ref : 253078

    City : Vacaville

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    GDUFA

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    01

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    • fda
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    Genentech

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : DSM Nutritional Products (UK) ...

    Business Address : Drakemyer Dalry Ayshire Unit...

    FEI Number : 3004291553

    Country : U.S.A

    Paid in : 2019

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    Genentech

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : DSM Nutritional Products AG

    Business Address : Hauptstrasse 4 Sisseln CH433...

    FEI Number : 3002807203

    Country : U.S.A

    Paid in : 2019

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    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : DSM Nutritional Products Franc...

    Business Address : 1 Boulevard D Alsace Village...

    FEI Number : 3004320990

    Country : U.S.A

    Paid in : 2019

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    04

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    BIO Partnering at JPM
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    • fda
    • EDQM
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    Genentech

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : DSM Nutritional Products GmbH

    Business Address : Emil Barell-Strasse 3 Grenza...

    FEI Number : 3004542694

    Country : U.S.A

    Paid in : 2019

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