REGULATORY INSPECTION HISTORY
| Sr. No. | Name of the Regulatory Authority(s) | Inspection Date(s) | Inspection Status |
|---|---|---|---|
| 01. | Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI) |
04 Dec 2018 to 05 Dec 2018 | Inspection Closed and Facility Approval granted on 21 Jan 2019 valid till 20 Jan 2022 |
| 02. | Spanish Agency of Medicines and Medical Devices (AEMPS-Spain) | 20 Nov 2019 to 22 Nov 2019 | Inspection Closed and Final Inspection Closure Report received dated 31 Jan 2020 |
| 03. | United States Food and Drug Administration (USFDA) | 28 Jul 2020 to 03 Aug 2020 | Remote Record Review Summary Report (RRR) received dated 30 Dec 2020 |
| 04. | Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI) |
17 Feb 2021 to 18 Feb 2021 | Inspection Closed and Facility Approval granted on 08 Apr 2021 valid till 07 Apr 2026 |
| 05. | National Health Surveillance Agency (ANVISA-Brazil) | 11 Apr 2022 to 18 Apr 2022 | Inspection Closed and Facility Certification granted from 16 May 2022 to 16 May 2024 |
| 06. | United States Food and Drug Administration (USFDA) | 12 Sep 2022 to 16 Sep 2022 | Establishment Inspection Report (EIR) received dated 20 Mar 2023 |
| 07. | United States Food and Drug Administration (USFDA) | 19 Sep 2022 to 22 Sep 2022 | Remote Regulatory Assessment Report (RRA) received dated 10 Mar 2023 |
| 08. | Medicines & Healthcare Products Regulatory Agency (MHRA) | 11 Sep 2023 to 15 Sep 2023 | Inspection Closed and GCP Inspection Statement received dated 02 Jan 2024 |
| 09. | Spanish Agency of Medicines and Medical Devices (AEMPS-Spain) & Health and Youth Care Inspectorate (Netherlands)-on behalf of European Medicines Agency (EMA) |
30 Oct 2023 to 01 Nov 2023 | Inspection Closed and Final Inspection Closure Report received dated 22 Dec 2023 |
| 10. | Gulf Health Council (GHC) | 22 Apr 2024 to 24 Apr 2024 | Inspection Closed and Facility Certification granted from 01 May 2024 valid till 30 Apr 2029 |
| 11. | National Pharmaceutical Regulatory Agency (NPRA-Malaysia) | 06 May 2024 to 10 May 2024 | Inspection Closed and Inspection Closure Letter received dated 19 Jul 2024 |
| 12. | National Health Surveillance Agency (ANVISA-Brazil) | 14 OCT 2024 to 18 Oct 2024 | Inspection Closed and Facility Certification granted from 16 May 2024 to 16 May 2026 |
| 13. | United States Food and Drug Administration (USFDA) |
24 Feb 2025 to 28 Feb 2025 | Establishment Inspection Report (EIR) received on 25 Jul 2025 |
| 14. | Ministry of Health of the Republic of Kazakhstan (MoH- Kazakhstan) |
04 Mar 2025 to 06 Mar 2025 | Inspection Closed and Final Inspection Closure Report received on 04 Jun 2025 |
| 15. | United States Food and Drug Administration (USFDA) | 14 Jul 2025 to 18 Jul 2025 | No Form 483s Issued. Establishment Inspection Report (EIR) Awaited |
| 16. | National Pharmaceutical Regulatory Agency (NPRA-Malaysia)- Facility Inspection | 15 Sep 2025 to 19 Sep 2025 | Inspection concluded with no observations and Inspection Report Awaited |
| Note: | In addition to the above regulatory authority inspection approvals, the projects have also been submitted and received approvals by sponsors from various other global regulatory agencies, Viz. Health Canada, Belarus, Switzerland, Jordan, Ukraine, Israel, Chile, Colombia, China, Denmark, Indonesia, Taiwan, Uganda, Thailand, Netherlands, Mexico, Russia, Finland, Latvia, Bulgaria, South Africa, Zambia, El Salvador, Philippines. |