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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/122/H/2024

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

Part 1

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

The competent authority of Italy confirms the following:

The manufacturer: Newchem S.p.A.

Site address: Via Roveggia 47, Verona, 37136, Italy

OMS Organisation Id. / OMS Location Id.: ORG-100017847 / LOC-100026610


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

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2023-03-30 , it is considered that it complies with:

  • 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. 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

    Manufacture of active substance. Names of substances subject to inspection:
    [00000000005896]CICLESONIDE(en)
    [0000000000568]BETAMETHASONE DIPROPIONATE(en)
    [0000000000572]BETAMETHASONE ACETATE(en)
    [00000000001850]FLUOROMETHOLONE(en)
    [00000000002145]HYDROCORTISONE SODIUM SUCCINATE(en)
    [00000000002158]HYDROCORTISONE SODIUM SUCCINATE BUFFERED STERILE(en)
    [00000000003217]PREDNISOLONE 17-VALERATE 21-ACETATE(en)
    [0000000000100948]ESTETROL MONOHYDRATE(en)
    [00000000001256]DESONIDE(en)
    [00000000004225]DIENOGEST(en)
    [00000000001880]FLUTICASONE FUROATE(en)
    [00000000005782]DEXAMETHASONE ACETATE MONOHYDRATE(en)
    [00000000005783]BETAMETHASONE BUTEPRATE(en)
    [00000000002484]LOTEPREDNOL ETABONATE(en)
    [00000000002631]METHYLPREDNISOLONE ACETATE(en)
    [00000000003853]TRIAMCINOLONE(en)
    [00000000003854]TRIAMCINOLONE ACETONIDE(en)
    [00000000001021]CLOBETASONE BUTYRATE(en)
    [0000000000665]BUDESONIDE(en)
    [00000000004281]GESTODENE(en)
    [00000000005588]PREDNISOLONE METASULFOBENZOATE SODIUM(en)
    [00000000002635]METHYLPREDNISOLONE HYDROGEN SUCCINATE(en)
    [0000000000986]CYPROTERONE ACETATE(en)
    [00000000007720]BERAPROST SODIUM(en)
    [00000000001231]DEXAMETHASONE ISONICOTINATE(en)
    [00000000001255]DESOGESTREL(en)
    [00000000004693]PREDNISOLONE SODIUM PHOSPHATE(en)
    [0000000000564]BETAMETHASONE SODIUM PHOSPHATE(en)
    [00000000002191]ILOPROST(en)
    [0000000000563]BETAMETHASONE(en)
    [00000000004244]DROSPIRENONE(en)
    [00000000002725]MOMETASONE FUROATE(en)
    [00000000002844]NOMEGESTROL ACETATE(en)
    [00000000002639]METHYLPREDNISOLONE SODIUM SUCCINATE BUFFERED STERILE(en)
    [00000000003758]TIBOLONE(en)
    [00000000001020]CLOBETASOL PROPIONATE(en)
    [0000000000100981]FLUTICASONE PROPIONATO(en)
    [00000000001203]DEFLAZACORT(en)
    [00000000002144]HYDROCORTISONE ACETATE(en)
    [00000000002638]METHYLPREDNISOLONE SODIUM SUCCINATE STERILE(en)
    [00000000005930]ULIPRISTAL ACETATE(en)
    [00000000001232]DEXAMETHASONE SODIUM PHOSPHATE(en)
    [0000000000565]BETAMETHASONE VALERATE(en)
    [00000000002146]HYDROCORTISONE BUTYRATE(en)
    [00000000002151]HYDROCORTISONE HYDROGEN SUCCINATE(en)
    [00000000005780]MEPREDNISONE(en)
    [00000000005781]MEPREDNISONE HEMISUCCINATE(en)
    [00000000005870]MOMETASONE FUROATE MONOHYDRATE(en)
    [0000000000611]BIMATOPROST(en)
    [00000000002375]LATANOPROST(en)
    [00000000003208]PREDNICARBATE(en)
    [00000000003849]TRAVOPROST(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:CICLESONIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BETAMETHASONE DIPROPIONATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BETAMETHASONE ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FLUOROMETHOLONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:HYDROCORTISONE SODIUM SUCCINATE
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:HYDROCORTISONE SODIUM SUCCINATE BUFFERED STERILE
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:PREDNISOLONE 17-VALERATE 21-ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,milling,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ESTETROL MONOHYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DESONIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DIENOGEST
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FLUTICASONE FUROATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DEXAMETHASONE ACETATE MONOHYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.4  Other:
    hydratation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BETAMETHASONE BUTEPRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:LOTEPREDNOL ETABONATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:METHYLPREDNISOLONE ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TRIAMCINOLONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TRIAMCINOLONE ACETONIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CLOBETASONE BUTYRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BUDESONIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:GESTODENE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:PREDNISOLONE METASULFOBENZOATE SODIUM
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:METHYLPREDNISOLONE HYDROGEN SUCCINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CYPROTERONE ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BERAPROST SODIUM
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    Special Requirements:
    7.Other:
    Prostaglandins
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DEXAMETHASONE ISONICOTINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DESOGESTREL
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:PREDNISOLONE SODIUM PHOSPHATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BETAMETHASONE SODIUM PHOSPHATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ILOPROST
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    Special Requirements:
    7.Other:
    prostaglandins
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BETAMETHASONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DROSPIRENONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MOMETASONE FUROATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:NOMEGESTROL ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:METHYLPREDNISOLONE SODIUM SUCCINATE BUFFERED STERILE
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TIBOLONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CLOBETASOL PROPIONATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FLUTICASONE PROPIONATO
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DEFLAZACORT
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:HYDROCORTISONE ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:METHYLPREDNISOLONE SODIUM SUCCINATE STERILE
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ULIPRISTAL ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DEXAMETHASONE SODIUM PHOSPHATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.3  Salt formation / Purification steps:
    salt formation,crystallisation
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BETAMETHASONE VALERATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:HYDROCORTISONE BUTYRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:HYDROCORTISONE HYDROGEN SUCCINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MEPREDNISONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MEPREDNISONE HEMISUCCINATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,sieving
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MOMETASONE FUROATE MONOHYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.4  Other:
    hydratation
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BIMATOPROST
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    Special Requirements:
    7.Other:
    prostaglandins
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:LATANOPROST
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    Special Requirements:
    7.Other:
    prostaglandins
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:PREDNICARBATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.3  Salt formation / Purification steps:
    crystallisation
    3.1.2  Manufacture of crude active substance
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.3  Secondary Packaging (placing the sealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.1  Physical processing steps:
    drying,micronisation
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TRAVOPROST
    3.5 General Finishing Steps
     
    3.5.4  Other:
    batch certification
    Special Requirements:
    7.Other:
    Prostaglandins
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    4. Other Activities - Active Substances:
    Importation of: BETAMETHASONE, DEXAMETHASONE, DEXAMETHASONE ACETATE (confidential), HYDROCORTISONE, MEDROXYPROGESTERONE ACETATE, METHYLPREDNISOLONE, PREDNISOLONE

    Clarifying remarks (for public users):
    According to Italian legislation, sterile active substances are authorized according to art. 40 of Dir. 2001/83/EC. For sterile active substances: salt formation, buffering, sterile filtration and freeze drying, microbiological testing (including sterility testing) are outsourced to other sites. Ulipristal Acetate is manufactured in different Crystal forms (Form A and Form B). Imported active substances marked as confidential undergo further processing within the importing site. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 42 months from the latest general GMP inspection conducted on 2023/03/30, except for AIFA¿s re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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