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Phyto Chemicals

Manufacturing Facilities

Dedicated plants for Colchicine and Thiocolchicoside

Equipment dedicated stage wise for each API

Risk of cross-contamination minimised primarily through infrastructural controls

MOC of all reactors and associated equipment - SS 316

Increasing trend in air classification in the plant as the process moves towards the final steps

Final crystallisation carried out in Class – 8 environment Site Regulatory History and Approvals

Site Regulatory History and Approvals

For Colchicine

European DMF for API – COS Ref No: R1 CEP 2002-062 REV 01
European GMP compliant certificate from MPA Sweden
DMF for US FDA – 20149

For Thiocolchicoside

DMF for Thiocolchicoside API – DMF No: 2000-077
AFSSAPS approved for EU-GMP

Certifications

Certified ISO 9001 for Quality Management System, ISO 14001 for Environmental Management System and ISO 45001 for Occupational Health and Safety Management System.