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Italian Medicines Agency

CERTIFICATE NUMBER: IT/E/API/07/2026

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: Indena India Private Limited

Site address: 43/3 Shivapura Post Ranganathpur, Dodaballapur, Bengaluru, 562163, India

OMS Organisation Id. / OMS Location Id.: ORG-100023776 / LOC-100032944


Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Art. 111(4) of Directive 2001/83/EC.

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

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on  2026-06-12 , it is considered that it complies with:

  • The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)
  • The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC.
    		•

    This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

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

    __________________________________________________________________________________________________________________________
    (1) The certificate referred to in paragraph Art. 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:
    THIOCOLCHICOSIDE(en)
    [AIFA7]COLCHICUM AUTUMNALE DRY STANDARDIZED EXTRACT 3,5%(en)
    [AIFA8]SENNOSIDES STANDARDIZED EXTRACT 45%(en)
    [AIFA 11]RAW COLCHICINE(en)
    [7487]CENTELLA ASIATICA LEAF (CENTELLA ASIATICA (L.), URBAN) INTERMEDIATE EXTRACT(en)
    COLCHICINE(en)

    3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

    Active Substance:THIOCOLCHICOSIDE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.5  Modification of extracted substance Plant 
    3.2.6  Purification of extracted substance Plant 
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:COLCHICUM AUTUMNALE DRY STANDARDIZED EXTRACT 3,5%
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, grinding, standardization
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:SENNOSIDES STANDARDIZED EXTRACT 45%
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.5  Modification of extracted substance Plant 
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, grinding, mixing, standardization
    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
    3.6.2  Microbiological testing excluding sterility testing

    Active Substance:RAW COLCHICINE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.2  Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)
    3.5.4  Other:
    active intermediate solution
    3.6 Quality Control Testing
     
    3.6.1  Physical / Chemical testing

    Active Substance:CENTELLA ASIATICA LEAF (CENTELLA ASIATICA (L.), URBAN) INTERMEDIATE EXTRACT
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.5 General Finishing Steps
     
    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:COLCHICINE
    3.2 Extraction of Active Substance from Natural Sources
     
    3.2.1  Extraction of substance from plant source
    3.2.6  Purification of extracted substance Plant 
    3.5 General Finishing Steps
     
    3.5.1  Physical processing steps:
    drying, milling
    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
    3.6.2  Microbiological testing excluding sterility testing

    4. Other Activities - Active Substances:
    External Warehouse located in Plot No. 277 KIADB 3rd Phase Obadenahalli Doddaballapura Bengaluru Rural 561205 India ORG-100023776; LOC-100103793

    Clarifying remarks (for public users):
    Raw Colchicine: active intermediate as a solution. Centella asiatica leaf (Centella asiatica (L.) Urban) intermediate extract: soft extract as an active intermediate

     

     


    		 
    		 
     
         
     
     
    		 
     
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