Best New Drug Coming in Pune
Protect Life Sciences Pvt Ltd is on the brink of unveiling the New drug coming in Pune—an investigational injectable targeting carbapenem‑resistant Gram‑negative pathogens. Designated PLS‑101, this novel β‑lactam/β‑lactamase inhibitor combination has shown potent in vitro activity against KPC, NDM, and OXA‑48 producers, with minimal resistance emergence in serial passage studies.
Manufactured under GMP conditions, pilot batches meet stringent purity and sterility specifications. Aseptic filling in single‑use systems prevents cross‑contamination, and container closure integrity tests guarantee vial integrity throughout distribution.
PLS‑101 has completed Phase II clinical trials in complicated intra‑abdominal infections, demonstrating superior clinical cure rates and a favorable safety profile. Phase III studies are ongoing at leading Pune hospitals, with interim data expected by Q3 2025.
Our regulatory affairs team is preparing dossiers for DCGI submission, backed by robust CMC, non‑clinical, and clinical data packages. A dedicated project management office ensures milestone tracking and timely communication with stakeholders.
To support launch readiness, our medical affairs unit is developing KOL advisory boards, educational symposia, and digital assets. Sustainability measures—such as water‑recycling systems and solar‑powered utilities—underscore our eco‑responsibility.
Stay tuned as Protect Life Sciences brings this breakthrough therapy to clinicians and patients in Pune and beyond.
Call us or visit us in Pune for more details.
