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Quality & Regulatory Certifications

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
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
ISO 13485: 2016 Certificate of Registration to Syngene for implementing Medical Device Quality Management Systems in the Formulation Unit (S15), Bengaluru
Validity: 09/2021
  to 09/2024
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
Drugs Control Department, Karnataka, Good Manufacturing Certificate for Syngene’s Biologics Unit (S2, S18), Bengaluru
Validity: 02/2023
  to 02/2028
Drugs Control Department, Karnataka, Good Manufacturing Certificate for Syngene’s Formulation Center (Block FDC, S18 and S19), Bengaluru
Validity: 02/2017
  to 02/2027
Drugs Control Department, Karnataka, Good Manufacturing Certificate for Syngene's Chemical Development Center (S14), Bengaluru
Validity: 12/2017
  to 12/2027
Drugs Control Department, Karnataka, Good Manufacturing Certificate for Syngene's API Manufacturing facility (MSEZ), Mangalore
Validity: 10/2020
  to 10/2025
Veterinary Medicines Directorate, UK, Certificate of GMP Compliance of a Manufacturer to Syngene, Bengaluru
Validity: 12/2022
  to 12/2025
Federal Agency of Medicines and Health Products, Belgium, Certificate of GMP Compliance of a Manufacturer to Syngene, Bengaluru
Validity: 01/2023
  to 01/2026
ISO/ IEC 27001:2013 Certificate to Syngene for implementing Information Security Management Systems in the IT Department and Business Functions at Hyderabad
Validity: 04/2022
  to 04/2025
ISO/ IEC 27001:2013 Certificate to Syngene for implementing Information Security Management Systems in the IT Department and Business Functions at MSEZ, Manga
Validity: 04/2022
  to 04/2025
ISO/ IEC 27001:2013 Certificate to Syngene for implementing Information Security Management Systems in the IT Department and Business Functions at VTP, Bengaluru
Validity: 04/2022
  to 04/2025
ISO/ IEC 27001:2013 Certificate to Syngene for implementing Information Security Management Systems in the IT Department and Business Functions at Semicon Park, Bengaluru
Validity: 04/2022
  to 04/2025
ISO/ IEC 27001:2013 Certificate to Syngene for implementing Information Security Management Systems in the IT Department and Business Functions at Biocon Park, Bengaluru
Validity: 04/2022
  to 04/2025
College of American Pathologists (CAP) Certificate of Accreditation to Syngene’s Central Laboratory, Bengaluru
Validity: 05/2022
  to 05/2024
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: 02/2022
  to 02/2024
Government of India, Central Drug Standard Control Organization, Registration Certificate for Syngene’s BA/BE Study Center, Bengaluru
Validity: 01/2020
  to 02/2025
AAALAC Accreditation on Care and Use of Laboratory Animals to Syngene, Bengaluru
Validity: 11/2022
  to 11/2025
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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