New digital platform provides global sponsors with live visibility into R&D, process development and GMP manufacturing operations, enhancing collaboration and decision-making
Madhav Bhutada says overdependence on large CDMOs and delayed engagement can increase development costs by up to 40% and slow clinical progress
Shilpa will deliver end-to-end services including CMC development, process scale-up, GMP clinical supply, and commercial manufacturing support
Veteran pharma leader brings 33+ years of experience to drive operational excellence in formulation business
Marks significant milestone for breakthrough biologic to treat rare blood cancers
New partnership combines Shilpa Biologicals’ development and manufacturing capabilities with SteinCares’ regional commercialization platform
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
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