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Italian Medicines Agency

CERTIFICATE NUMBER: IT/E/GMP/API/01/2024

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER

Part 1

The competent authority of ITALIE confirms the following:

The manufacturer: Indena India Private Limited

Site address:

43/3 Shivapura Post Ranganathpur, Dodaballapur, Bengaluru, Karnataka, 561203, India

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

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 2023-06-16 , it is considered that it complies with:

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

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.4 Other products or manufacturing activity

1.4.1 Manufacture of
1.4.1.3 Other: active substances(en)

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

Clarifying remarks (for public users):

Raw colchine: active intermediate as a solution. Centella asiatica leaf (Centella asiatica (L.) Urban) intermediate extract: soft extract as an active intermediate

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