Piramal Pharma Limited (PPL) declared on Tuesday that it signed a Master Services Agreement (MSA) to perform services related to the development, manufacture and supply of RNL-Liposome Intermediate Drug Product.
The MSA was reportedly signed between Piramal Pharma Limited's (PPL) Contract Development and Manufacturing Organization (CDMO), Piramal Pharma Solutions (PPS) and Plus Therapeutics Inc, a clinical-stage pharmaceutical company.
This MSA includes transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing as well as stability studies. The transfer will be performed at the PPS drug product facility located in Lexington, Kentucky. MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development.
In addition, PPS' Lexington site has the capability to support drug development for New Chemical Entities (NCEs), generics and molecules that might be following the 505(b)(2) regulatory pathway.
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