Regulatory certifications
Key to Enzene locations
ISO 14001:2015 environmental management system (EMS) certification
- Validity: Up to 30 April 2029
ISO 45001:2018 Occupational health & safety management system (OHSMS) certification
- Validity: Up to 28 July 2029
Food and drug administration (FDA) (state FDA) and WHO GMP for unit I
- Validity: 28 May 2028
Food and drug administration (FDA) (state FDA) for unit II
- Validity: 10 Mar 2028
Turkey MoH
- Validity: 13 Jul 2029
ANVISA
- Validity: 03 Dec 2027
European medical agency (EMA) certification for unit I and II
- Validity: 24 Feb 2028
ISO 13485:2016 for unit I
- Validity: 11 Mar 2029
Factory license for unit I, II, and III
- Validity: Up to 31 Dec 2028
Maharashtra pollution control board consent to operate copy for unit II
- Validity for unit II: Up to 31 Oct 2027
- Validity for unit I and III: Up to 31 Jul 2027
Petroleum explosive safety organization license for light diesel oil (LDO) and diesel
- Validity: Up to 31 Dec 2028
Maharashtra industrial development corporation fire no objection certificate (NOC) for unit I and III
- Validity: No expiration
Extended producer responsibility (EPR) registration certificate for importers
- Validity: No expiration
Hazardous waste membership certificate for unit I and III
- Validity: Up to 12 Nov 2029
Biomedical waste disposal membership certificate for Unit II
- Validity: Up to 31 Mar 2028
Hazardous waste membership certificate for unit II
- Validity: Up to 18 Dec 2029
Maharashtra industrial development corporation plan approval for unit I and III
- Validity: No expiration
Building completion certificate
- Validity: No expiration
Certificate of merit from national safety council for unit I and II
- Received in 2023 and 2024
Alcumus ISOQAR ISO 27001:2022 certification of HO, manufacturing units, and R&D center
- Validity: Up to 9 April 2027
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