Lupin starts work on a new plant in India; FDA warning letters focus on contamination;

> Lupin, which already operates 11 manufacturing plants in India and Japan, has started construction of a new formulation facility in Mihan, Nagpur, India, which it expects to complete next year. Story

> Dalton Pharma Services in Canada has a contract to manufacture an antiviral agent developed by Defense Research and Development Canada (DRDC), for clinical trials in anticipation of getting the commercial contract later. Item

> An analysis by in-PharmaTechnologist of 2011 FDA warning letters found that a third of agency observations concerned the failure to have written procedures to prevent microbiological contamination. Report

> CRO Reaction Biology Corporation (RBC) has increased its epigenetic production capacity with a new facility in Malvern, PA. Article

> Industrial enzyme developer Codexis has gotten FDA approval for a new production process for manufacturing sitagliptin, the API in Merck's ($MRK) Januvia. More


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.