Quality & Regulatory Certifications

Quality & Regulatory Certifications
Other Certifications
ISO 14001-2015: Contract Services in Manufacture and Testing of Small Molecule (Intermediate and Drug Substance)
Validity: 09/2025
  to 08/2028
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ISO 45001-2018: Contract Services in Manufacture and Testing of Small Molecule (Intermediate and Drug Substance)
Validity: 07/2025
  to 06/2027
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ISO 50001-2018: Contract Services in Manufacture and Testing of Small Molecule (Intermediate and Drug Substance)
Validity: 04/2025
  to 04/2028
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ISO 14001: 2014 Certificate to Syngene for implementing Environment Management Systems in Contract Research for Drug Discovery and Contract Manufacturing of Pharmaceuticals and Biopharmaceuticals.
Validity: 01/2023
  to 11/2025
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ISO 45001-2018 Certificate to Syngene for implementing Occupational Health and Safety Management Systems in Contract Research for Drug Discovery and Contract Manufacturing of Pharmaceuticals and Biopharmaceuticals.
Validity: 01/2023
  to 11/2025
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ISO 13485: 2016 Certificate of Registration to Syngene for implementing Medical Device Quality Management Systems in HO/Unit I and II, Bengaluru
Validity: 09/2024
  to 09/2027
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ISO 9001: 2015 Certificate to Syngene for implementing Management Systems in Small Molecule Discovery, Development, Manufacturing, Testing and Stability; Large Molecule Drug Substance and Viral Testing (HO & Unit 1), Bengaluru
Validity: 01/2023
  to 08/2025
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Drugs Control Department, Karnataka, Good Manufacturing Certificate for Syngene’s Biologics Unit (S2, S18), Bengaluru
Validity: 02/2023
  to 02/2028
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Drugs Control Department, Karnataka, Good Manufacturing Certificate for Syngene’s Formulation Center (Block FDC, S18 and S19), Bengaluru
Validity: 02/2017
  to 02/2027
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Drugs Control Department, Karnataka, Good Manufacturing Certificate for Syngene's Chemical Development Center (S14), Bengaluru
Validity: 12/2017
  to 12/2027
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ISO 27001:2022 - Hyderabad
Validity: 04/2023
  to 04/2028
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ISO 27001:2022 – MSEZ (Mangalore)
Validity: 04/2023
  to 04/2028
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ISO 27001:2022 – Semicon Park
Validity: 04/2023
  to 04/2028
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ISO 27001:2022 – BIOCON PARK (Data Center & Dedicated Centers)
Validity: 04/2023
  to 04/2028
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ISO 27001:2022 – VTP Corporate Office
Validity: 04/2023
  to 04/2028
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College of American Pathologists (CAP) Certificate of Accreditation to Syngene’s Central Laboratory, Bengaluru
Validity: 05/2024
  to 05/2026
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National Accreditation Board for Testing and Calibration Laboratories (NABL) Accreditation Certificate to Syngene's Central Laboratory, Bengaluru, for conforming with ISO 15189:2012, Medical Laboratories – Requirements for Quality and Competence
Validity: 02/2024
  to 02/2026
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Government of India, Central Drug Standard Control Organization, Registration Certificate for Syngene’s BA/BE Study Center, Bengaluru
Validity: 01/2020
  to 02/2025
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AAALAC Accreditation on Care and Use of Laboratory Animals to Syngene, Bengaluru
Validity: 11/2022
  to 11/2025
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Certificate of GLP Compliance by National GLP Compliance Monitoring Authority (NGCMA), Department of Science and Technology (DST), Government of India (https://dst.gov.in/ngcma) for compliance with OECD principles of GLP to Syngene, Bengaluru
Validity: 10/2022
  to 10/2025
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