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- Piramal Pharma Solutions has entered a manufacturing partnership with Botanix Pharmaceuticals to support development and commercial supply of Sofdra, the first and only FDA-approved new chemical entity for primary axillary hyperhidrosis. - The collaboration will utilize PPS's North American facilities in Riverview, Michigan and potentially Aurora, Canada to provide dual-source API manufacturing capabilities for enhanced supply chain security. - The twin-site strategy aims to derisk Sofdra's supply chain while providing Botanix with significant cost reductions and ensuring consistent patient access to this breakthrough therapy. - PPS will initiate development and validation services for Sofpironium Bromide, Sofdra's active pharmaceutical ingredient, leveraging decades of combined experience in drug substance manufacturing.
- Piramal Pharma Solutions' Grangemouth facility reached a significant milestone by delivering its 1,500th antibody-drug conjugate (ADC) batch, with the landmark batch representing a commercial oncology ADC product. - The achievement demonstrates over two decades of specialized ADC expertise, with Piramal being the first FDA-approved ADC CDMO and the first to commercially manufacture an ADC. - The facility has developed hundreds of unique bioconjugates and maintains strong regulatory credentials including US FDA and MHRA accreditations. - Piramal has also announced a strategic collaboration with Ajinomoto Bio-Pharma Services to enhance ADC development capabilities through AJICAP™ technology integration.
- Piramal Pharma Solutions successfully developed and commercialized tablet-in-capsule drug delivery technology at its facilities in Pithampur and Ahmedabad, India. - The technology enables dual actives or dual-release profiles within a single capsule, providing enhanced dosing flexibility and improved medication adherence for patients. - The project was completed in just five months through seamless technology transfer between sites, demonstrating Piramal's integrated manufacturing capabilities. - This advancement allows incompatible active ingredients to be combined in one capsule while maintaining formulation stability and enabling personalized medicine approaches.
- Piramal Pharma Solutions has successfully completed its comprehensive action plan to achieve regulatory compliance with global nitrosamine drug substance-related impurities (NDSRI) guidelines. - The company implemented extensive risk assessments, confirmatory testing, and control strategies across all drug substances and products to ensure patient safety. - Significant investments were made in state-of-the-art testing equipment and capabilities at Ahmedabad and Digwal facilities to expedite compliance processes and prevent drug shortages. - All existing Piramal commercial products now comply with global regulatory requirements, with new customer product batches requiring regulatory alignment before execution.
- Piramal Pharma Solutions' Grangemouth facility in Scotland has received updated three-year MHRA GMP certificates covering all operations in its specialized Helix building. - The facility serves as Piramal's dedicated antibody-drug conjugate development and manufacturing site, supporting both clinical and commercial drug substance production. - The certification strengthens the facility's regulatory standing and supports its role in the ADCelerate program, which aims to accelerate bioconjugate therapy development from R&D to GMP manufacturing.
- Piramal Pharma Solutions has acquired a state-of-the-art Korsch XM-12 bilayer tablet press at its Morpeth, UK facility to enhance formulation development capabilities. - The new equipment enables production of both single-layer and bilayer tablets with advanced features for high potency API containment and rapid changeovers. - The facility's Formulation Development Team will undergo comprehensive training protocols to ensure safe operation and high-quality output from the XM-12. - This strategic investment reinforces Piramal's commitment to advancing drug delivery technologies and delivering innovative therapies to patients worldwide.
