Drug factory · FDA FEI 3017604745
Novugen Pharma Sdn. Bhd.
No 27, Jalan Lengkuk Teknologi 2, Taman Teknologi Enstek Fasa 1, Bandar Baru Enstek, Malaysia
No problems found at FDA's last inspection, Oct 25, 2024.
No Action Indicated: inspectors found no objectionable conditions.
1 drug inspection on record since 2024: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Midodrine | Makes it | Novugen Pharma (USA) LLC. | 82293-003, 82293-004, 82293-005 |
| Sacubitrilat and Valsartan | Makes it | Novugen Pharma (USA) LLC. | 82293-027, 82293-028, 82293-029 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 25, 2024 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.