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Italian Medicines Agency

CERTIFICATE NUMBER: IT-API/47/H/2026

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: Industriale Chimica S.r.l.

Site address: Via Edvard Hagerup Grieg 13, Saronno, 21047

OMS Organisation Id. / OMS Location Id.: ORG-100011692 / LOC-100020331


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  2025-10-17 , 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:
    [0000000007004]ABIRATERONE ACETATE(en)
    [0000000005958]OBETICHOLIC ACID(en)
    [0000000005209]BECLOMETASONE DIPROPIONATE(en)
    [0000000006004]BECLOMETASONE DIPROPIONATE MONOHYDRATE(en)
    [000000000611]BIMATOPROST(en)
    [000000000640]BRINZOLAMIDE(en)
    [000000000665]BUDESONIDE(en)
    [000000000672]BUMETANIDE(en)
    [000000000101090]CLASCOTERONE(en)
    [0000000004420]DALFAMPRIDINE(en)
    [0000000001255]DESOGESTREL(en)
    [0000000004225]DIENOGEST(en)
    [0000000005555]DOFETILIDE(en)
    [0000000004244]DROSPIRENONE(en)
    [000000000101394]ENSIFENTRINE(en)
    [0000000005681]EPLERENONE(en)
    [0000000001610]ETHINYLESTRADIOL(en)
    [0000000001623]ETONOGESTREL(en)
    [0000000001705]FENOTEROL HYDROBROMIDE(en)
    [0000000004260]PHENTOLAMINE MESYLATE(en)
    [0000000001880]FLUTICASONE FUROATE(en)
    [000000000100981]FLUTICASONE PROPIONATE(en)
    [0000000001895]FORMOTEROL FUMARATE DIHYDRATE(en)
    [0000000001948]FULVESTRANT(en)
    [000000000100865]GANAXOLONE(en)
    [0000000004281]GESTODENE(en)
    [0000000004640]GLYCOPYRRONIUM BROMIDE(en)
    [0000000002133]IDEBENONE(en)
    [0000000007350]INDACATEROL MALEATE(en)
    [0000000008748]CRUDE IVERMECTIN(en)
    [0000000002375]LATANOPROST(en)
    [0000000002419]LEVONORGESTREL(en)
    [0000000004434]LEVONORGESTREL BUTYRATE(en)
    [0000000002484]LOTEPRENDOLOLO ETABONATO(en)
    [0000000002552]MEMANTINE HYDROCHLORIDE(en)
    [0000000002691]MIDODRINE HYDROCHLORIDE(en)
    [0000000002725]MOMETASONE FUROATE(en)
    [0000000005870]MOMETASONE FUROATE MONOHYDRATE(en)
    [0000000002844]NOMEGESTROL ACETATE(en)
    [0000000004335]NORGESTIMATE(en)
    [000000000101343]OLODATEROL HYDROCHLORIDE(en)
    [0000000008792]RELUGOLIX(en)
    [0000000003444]SALMETEROL XINAFOATE(en)
    [0000000004715]SULFAMETHYLTHIAZOLE(en)
    [0000000003758]TIBOLONE(en)
    [0000000007098]TIOTROPIUM BROMIDE MONOHYDRATE(en)
    [0000000007051]TIOTROPIUM BROMIDE SOLVATE(en)
    [0000000003849]TRAVOPROST(en)
    [0000000005930]ULIPRISTAL ACETATE(en)
    [000000000100007]UMECLIDINIUM BROMIDE(en)
    [0000000007202]VILANTEROL TRIFENATATE(en)
    [0000000004092]ZOPICLONE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:ABIRATERONE ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, milling/ micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:OBETICHOLIC ACID
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BECLOMETASONE DIPROPIONATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BECLOMETASONE DIPROPIONATE MONOHYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BIMATOPROST
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Prostagladins
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BRINZOLAMIDE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BUDESONIDE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:BUMETANIDE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CLASCOTERONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling/ micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DALFAMPRIDINE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DESOGESTREL
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, milling/ micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DIENOGEST
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DOFETILIDE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:DROSPIRENONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ENSIFENTRINE
    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:
    Crystallization, Filtration, Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:EPLERENONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ETHINYLESTRADIOL
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ETONOGESTREL
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FENOTEROL HYDROBROMIDE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:PHENTOLAMINE MESYLATE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FLUTICASONE FUROATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FLUTICASONE PROPIONATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FORMOTEROL FUMARATE DIHYDRATE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:FULVESTRANT
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:GANAXOLONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Filtration
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling/ micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:GESTODENE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:GLYCOPYRRONIUM BROMIDE
    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:
    Crystallization, Filtration
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling/ micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:IDEBENONE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:INDACATEROL MALEATE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CRUDE IVERMECTIN
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:LATANOPROST
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    prostaglandines
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Filtration, Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Filtration
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:LEVONORGESTREL
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:LEVONORGESTREL BUTYRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:LOTEPRENDOLOLO ETABONATO
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MEMANTINE HYDROCHLORIDE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MIDODRINE HYDROCHLORIDE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MOMETASONE FUROATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:MOMETASONE FUROATE MONOHYDRATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:NOMEGESTROL ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:NORGESTIMATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:OLODATEROL HYDROCHLORIDE
    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:
    Crystallization, Filtration, Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling/ micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:RELUGOLIX
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization, Filtration, Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, milling/ micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:SALMETEROL XINAFOATE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:SULFAMETHYLTHIAZOLE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TIBOLONE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TIOTROPIUM BROMIDE MONOHYDRATE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TIOTROPIUM BROMIDE SOLVATE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:TRAVOPROST
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    prostaglandins
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ULIPRISTAL ACETATE
    3.1 Manufacture of Active Substance by Chemical Synthesis
     
    3.1.1  Manufacture of active substance intermediates
    Special Requirements:
    7.Other:
    Other: Hormones or substances with hormonal activity
    3.1.2  Manufacture of crude active substance
    3.1.3  Salt formation / Purification steps:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:UMECLIDINIUM BROMIDE
    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:
    Crystallization, Purification
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:VILANTEROL TRIFENATATE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:ZOPICLONE
    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:
    Crystallization
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    Drying, Sieving, Micronization
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    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)
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    4. Other Activities - Active Substances:
    Importation of: ULIPRISTAL (confidential), GESTONORONE ACETATE (confidential), ESTRONE (confidential), AVERMECTIN (confidential), ESTRADIOL HEMIHYDRATE (confidential), ABIRATERONE (confidential), PREDNISOLONE (confidential)

    Clarifying remarks (for public users):
    Imported active substances marked as confidential undergo further processing within the importing site. Clascoterone is manufactured in Form II and Form III. On a risk-based approach, the validity of the GMP certificate for this manufacturing site is not more than 36 months from the latest general GMP inspection conducted on 2024/11/29, except for AIFA's re-evaluation of the risk profile.

     

     


    		 
    		 
     
         
     
     
    		 
     
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