Solara Active Pharma Science stops manufacturing and distribution of Ranitidine API for US market

Solara Active Pharma Science shared updates on its Ranitidine API as USFDA publishes a statement on 01 April 2020, requesting all finished dosage formulations manufacturers to withdraw prescription and over-the-counter (OTC) Ranitidine drugs in all dosage formats from the US market immediately.

As per USFDA's statement, the agency has determined that the NDMA impurity in some Ranitidine formulation products increases over time and when stored at higher than room temperatures it may result in consumer exposure to unacceptable levels of NDMA impurity. As a result of this immediate market withdrawal request for all Ranitidine products, Solara has stopped further manufacturing and distribution of Ranitidine API for the US market. The Company shall engage with its formulation partners to understand the next steps and additional data that it needs to generate for supporting their product's relaunch to the market in an extended period.

 

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