Regulatory Status
| Product Name | Grade | Country / Authority | DMF No. | Remarks |
| Tacrolimus | USP | United States | 41828 | VAI Received (30/03/26) |
| Tacrolimus Monohydrate | Ph. Eur. | Europe (CEP) | 2023-394-P01 | Certificate Received (Sep-2025) |
| Tacrolimus | USP | South Korea | FB/TR-US/CP/01/2025 | Certificate Received (Feb-2026) |
| Tacrolimus Monohydrate | Ph. Eur. | Malaysia (NPRA) | FB/TR-EP/CP/00/2024 | Submitted |
| Tacrolimus | USP | Malaysia (NPRA) | FB/TR-US/CP/01/2025 | Submitted |
| Tacrolimus | USP | Vietnam | FB/TR-US/CP/01/2024 | Submitted |
| Ciclosporin | Ph. Eur. | Europe (CEP) | 2025-517-P01 | Submitted |
| Ciclosporin | USP | Europe (CEP) | 2025-517-P01 | Submitted |
| Cyclosporine | USP | South Korea | FB/CS-US/CP/00/2025 | Certificate Received (Apr-2026) |
| Mupirocin Calcium | Ph. Eur. | Europe (CEP) | 2024-207-P01 | Submitted |
| Mupirocin Calcium | USP | United States | 42235 | Submitted |
| Mupirocin Calcium | USP | Turkey | FB/MC/CP/00/2023 | Submitted |
| Mupirocin | BP | Tanzania | FB/MU/CP/00/2024 | Submitted |
| Mupirocin | BP | Tanzania | FB/MU-BP/CP/00/2025 | Submitted |
Accreditations in Process
US-FDA
EDQM
ANVISA
NPRA
TMDA
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