| Standard/Certification Body | Inspection Year |
|---|---|
| ISO–9001:2015, SGS | Initial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
| ISO–9001:2015, SGS | Initial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
| ISO–9001:2015, SGS | Initial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
| Standard/Certification Body | Inspection Year |
|---|---|
| ISO–9001:2015, SGS | Initial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
| ISO–9001:2015, SGS | Initial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
| ISO–9001:2015, SGS | Initial inspection in 1997 and thereafter periodic surveillance and recertification audits happening regularly as per the schedule. |
| Regulatory Authority | Inspection Year |
|---|---|
| US – FDA | 2000, 2004, 2008, 2011, 2014, 2018, and 2019 |
| EU – GMP | 2011, 2016, and 2025 |
| Health Canada | 2023 |
| Japan – PMDA | 2011 and 2023 |
| Korea – MFDS | 2011 and 2023 |
| Mexico – COFEPRIS | 2014 |
| Brazil – ANVISA | 2016 |
| Name of the Compound | Initial DMF Filing Year |
|---|---|
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
| Bupropion HCl | 2005 |
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