News | August 27, 2025
SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
Mangalam Drugs and Organics receives repeat export order worth $ 21, 81,040
This project shall be implemented through incorporation of a new joint venture company in Zambia
The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site's capabilities
Rocket will also collaborate with investigators to implement an immunomodulatory regimen more closely reflecting that administered in the Phase 1 pediatric cohort
According to IQVIA sales data for the 12-month period ending June 2025, the Mycamine for Injection, 50 mg/vial and 100 mg/vial market achieved annual sales of approximately $60.7 million
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
The projected business potential is around US$ 1 million in the first year
Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025
Subscribe To Our Newsletter & Stay Updated
