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Italian Medicines Agency

CERTIFICATE NUMBER: IT/218/H/2023

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of Italy confirms the following:

The manufacturer: Alfasigma S.p.A.

Site address:

Via Pontina Km 30400, Pomezia, 00071, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100006058 / LOC-100023525

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. aM174/2023 in accordance with Art. 40 of Directive 2001/83/EC.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2021-05-28 , it is considered that it complies with:

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

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.1 Sterile products

   1.1.1  Aseptically prepared (processing operations for the following dosage forms)
           1.1.1.4  Small volume liquids
                  Special Requirements:
                   7  Other: Hormones or substances with hormonal activity(en)
   1.1.2  Terminally Sterilised (processing operations for the following dosage forms)
           1.1.2.3  Small volume liquids
   1.1.3  Batch certification

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.1  Capsules, hard shell
           1.2.1.2  Capsules, soft shell
           1.2.1.6  Liquids for internal use
           1.2.1.8  Other solid dosage forms: Powders/granules; also biologicals(en)
           1.2.1.11  Semi-solids
           1.2.1.12  Suppositories
           1.2.1.13  Tablets
                  Special Requirements:
                   7  Other: Hormones or substances with hormonal activity(en)
   1.2.2  Batch certification

1.3 Biological medicinal products (list of product types)

   1.3.1  Biological medicinal products (list of product types)
           1.3.1.6  Human or animal extracted products
           1.3.1.8  Other: Live biotherapeutic products powders/granules(en)
   1.3.2  Batch Certification (list of product types)
           1.3.2.6  Human or animal extracted products
           1.3.2.8  Other: Live biotherapeutic products powders/granules(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.1  Capsules, hard shell
           1.5.1.2  Capsules, soft shell
           1.5.1.6  Liquids for internal use
           1.5.1.8  Other solid dosage forms: Powders/granules(en)
           1.5.1.11  Semi-solids
           1.5.1.12  Suppositories
           1.5.1.13  Tablets
                  Special Requirements:
                   7  Other: Hormones or substances with hormonal activity(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

   1.6.1  Microbiological: sterility
   1.6.2  Microbiological: non-sterility
   1.6.3  Chemical/Physical
   1.6.4  Biological

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.2 Microbiological: non-sterility
2.1.3 Chemical/Physical

2.2 Batch certification of imported medicinal products

2.2.2 Non-sterile products

2.3 Other importation activities

2.3.1 Site of physical importation
2.3.2 Importation of intermediate which undergoes further processing

Clarifying remarks (for public users):

1.2.1.2 Capsules, soft shell: also animal extracted products; 1.2.1.8 Other solid dosage forms: Powders/granules; also biologicals; 1.3.1.6 Human or animal extracted products: animal extracted products in soft capules; 1.3.1.8 Other organic medicinal products: Live biotherapeutic products powders/granules; 1.3.2.6 Human or animal extracted products: animal extracted products; 1.3.2.8 Other organic medicinal products: Live biotherapeutic products powders/granules; 1.5.1.8 Other solid dosage forms: powders/granules; 1.6.4 Biological: in vitro, LAL test; 2.2.2 Non-sterile products: medicated plasters; 2.3.2 Importation of intermediate which undergoes further processing: microgranules for the manufacture of hard capsules including primary and secondary packing,testing and batch certification; transdermal patches which undergo secondary packing, testing and batch certification.

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