| Authority | Year | Document |
|---|---|---|
| USFDA, United States | 2016, 2024 | Establishment Inspection Report (EIR) |
| PMDA, Japan | 2023 | GMP Compliance Inspection Result Report, Accreditation of Foreign Drug Manufacturer (AFM) |
| Anvisa, Brazil | 2024 | Good Manufacturing Practice certificate (CBPF) |
| CDSCO, India | 2025 | WHO GMP |
| State Drug Control Administration, India | 2026 | GMP certificate (Schedule M) |
| Standard | Scope | Certified by |
|---|---|---|
| ISO 9001:2015 | Quality management | Perry Johnson Registrars |
| ISO 14001:2015 | Environmental management | Perry Johnson Registrars |
| ISO 45001:2018 | Occupational health and safety | Perry Johnson Registrars |
| Product | USDMF | CEP (year) | JDMF | KDMF | CBPF | Other |
|---|---|---|---|---|---|---|
| Terbinafine Hydrochloride | Yes | 2022 | - | - | - | IDL China (2024), 2 Secondary USDMFs |
| Fluconazole | Yes | 2022 | - | Yes | Yes | Health Canada |
| Losartan Potassium | Yes | 2025 | - | - | - | - |
| Voriconazole | Yes | 2024 | - | - | Yes | - |
| Ambroxol Hydrochloride | - | 2024 | - | - | - | - |
| Irbesartan | Yes | 2026 | - | - | - | - |
| Escitalopram Oxalate | Yes | 2026 | Yes | - | Yes | Secondary USDMF |
| S-Amlodipine Besylate | - | - | - | - | Yes | - |
| Fexofenadine Hydrochloride | - | 2025 | - | - | - | - |
| Mebeverine Hydrochloride | - | 2026 | - | - | - | - |
| Sumatriptan Succinate | - | - | - | Yes | Yes | - |
| Vortioxetine Hydrochloride | - | - | - | Yes | - | - |
| Vortioxetine Hydrobromide | - | - | - | - | Yes | - |
| Tadalafil | - | - | - | - | Yes | - |
| Dapoxetine Hydrochloride | - | - | - | - | Yes | - |
| Luliconazole | - | - | - | - | Yes | - |
Synergene Active Ingredients Corporate Office, H.No.8-2-293/82/J-III/304-O, Plot No.304, Road No.78, Jubilee Hills, Hyderabad 500033, Telangana, India.
+91-40-23817500
sales@synergeneapi.com
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