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The Certificate has been withdrawn, withdrawn date is : 2025-12-18

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Swissmedic Swiss Agency for Therapeutic Products

CERTIFICATE NUMBER: GMPEI-CH-1007681

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

Issued under the provisions of the Mutual Recognition Agreement between the European Union and Switzerland .
Issued following an inspection in accordance with

The competent authority of Switzerland confirms the following:

The manufacturer: F. Hoffmann-La Roche AG

Site address:	Grenzacherstrasse 124, Basel Town, 4058, Switzerland
Additional details on units inspected:	*This GMP-Certificate is valid for the site registered with Swissmedic: F. Hoffmann-La Roche AG Basel Grenzacherstrasse, Herstellung Wirkstoffe und Arzneimittel (NCA Reference Key: 1005965)*

OMS Organisation Id. / OMS Location Id.: ORG-100001445 / LOC-100000954

Other

(Investigational product) According to Swiss regulations in force: Therapeutic products act, TPA, SR 812.21 and Medicinal products licensing ordinance, MPLO, RS 812.212.1

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-05-09 , it is considered that it complies with: The Good Manufacturing Practice requirements referred to in the Agreement of Mutual Recognition between the European Union and Switzerland

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

Part 2

Human Investigational Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.8  Other solid dosage forms
           1.2.1.13  Tablets
   1.2.2  Batch certification

1.5 Packaging

1.5.1 Primary Packaging
1.5.1.8 Other solid dosage forms

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

Manufacture of active substance. Names of substances subject to inspection:

[171]SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:SWISSMEDIC LIST OF APIS, SEE 4 ACTIVE SUBSTANCES

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1  Manufacture of active substance intermediates

3.1.2  Manufacture of crude active substance

3.1.3  Salt formation / Purification steps:
Final and Finishing Step

3.3 Manufacturing of Active Substance using Biological Processes

3.3.2  Cell Culture:
-

3.3.3  Isolation / Purification

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

4. Other Activities - Active Substances:
List of active substances: Chemical drug substances: Cilazapril, Cobimetinib, Entrectinib, Erlotinib, Ibandronate, Inavolisib, Isotretinoin, Midazolam, Midazolam Maleate, Investigational Medicinal Products for use in clinical trials (chemical drug substances), Oseltamivir Phosphate, Risdiplam, Vemurafenib. Biological drug substances: Atezolizumab, Bevacizumab, Emicizumab, Faricimab, Mosunetuzumab, Ocrelizumab, Polatuzumab Vedotin (Antibody Drug Conjugate), Trastuzumab-Emtansine (Antibody Drug Conjugate), Monoclonal Antibodies for use in clinical trials (Investigational Medicinal Product)

Withdrawal comments in English: replaced by updated GMP-certificate (on the base of the new MIA) ersetzt durch ein aktualisiertes GMP-Zertifikat (auf der Basis des neuen MIA-Eintrags)

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For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.