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Finnish Medicines Agency

CERTIFICATE NUMBER: FIMEA/2024/000416

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 80(5) of Directive 2001/82/EC as amended
Art. 15 of Directive 2001/20/EC as amended
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Finland confirms the following:

The manufacturer: Fermion Oy

Site address:

Orioninkatu 2, Hanko Pohjoinen, 10960, Finland

OMS Organisation Id. / OMS Location Id.: ORG-100011508 / LOC-100020981

DUNS Number: 53-799-3060

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. FIMEA/2025/006228 in accordance with Art. 88 of Regulation (EU) 2019/6, Art. 13 of Directive 2001/20/EC and Art. 40 of Directive 2001/83/EC.

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

Other

(Human) API

(Veterinary) API

(Investigational product) API

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2024-03-14 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572 and/or Commission Delegated Regulation (EU) 2017/1569, as reflected by the product categories stated in Part 2. (3)

The principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC. (3)

The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC.

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. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). 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.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 80(5) of Directive 2001/82/EC, Art. 15 of Directive 2001/20/EC and Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products
Human Investigational Medicinal Products
Veterinary Medicinal Products

1 MANUFACTURING OPERATIONS

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: API(en)

1.6 Quality control testing

1.6.3 Chemical/Physical

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

AZATHIOPRINE(en)

CANNABIDIOL(en)

CARBIDOPA(en)

DAROLUTAMIDE(en)

DILTIAZEM HYDROCHLORIDE(en)

ENTACAPONE(en)

FLUTAMIDE(en)

GLIPIZIDE(en)

QUETIAPINE FUMARATE(en)

SODIUM CROMOGLICATE(en)

TOLNAFTATE(en)

HYDROXYCHLOROQUINE SULFATE(en)

BUSPIRONE HYDROCHLORIDE(en)

NINTEDANIB ESYLATE(en)

[002451]TRILACICLIB DIHYDROCHLORIDE DIHYDRATE(en)

[12123]LEROCICLIB DIHYDROCHLORIDE TRIHYDRATE(en)

ALPRAZOLAM(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:AZATHIOPRINE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:CANNABIDIOL

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:CARBIDOPA

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:DAROLUTAMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:DILTIAZEM HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:ENTACAPONE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:FLUTAMIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:GLIPIZIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:QUETIAPINE FUMARATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:SODIUM CROMOGLICATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:TOLNAFTATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:HYDROXYCHLOROQUINE SULFATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:BUSPIRONE HYDROCHLORIDE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:NINTEDANIB ESYLATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:TRILACICLIB DIHYDROCHLORIDE DIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:LEROCICLIB DIHYDROCHLORIDE TRIHYDRATE

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Active Substance:ALPRAZOLAM

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.2  Manufacture of crude active substance

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

Clarifying remarks (for public users):

The manufacturing authorization covers also the manufacturing and testing of non-sterile active pharmaceutical ingredients for clinical studies by chemical synthesis excluding cytostatics, hormones and antibiotics. The manufacturing also covers maufacturing of intermediates.

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

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.