FDA Clears Lupin API Site Of NDMA Risk, Compliance Efforts Ongoing
Lupin’s Tarapur API site for ‘sartans’, including valsartan, has been cleared of NDMA concerns by the US FDA, and the Indian firm has also provided analytical reports to EU authorities to affirm its case. The FDA inspection, though, did end with a lone observation at the site.
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Alembic moved fast and seized supply opportunities for valsartan, the hypertension drug that has seen shortages in the US, though management maintains that fundamental changes to the US market are there to stay given the backdrop of buying power of distributors.
The compliance chief for FDA’s center for drugs said API makers need to do a better job of testing their products for impurities to avoid exposing patients to safety risks, as has occurred with at least one supplier’s valsartan API.
An under pressure US business dented Lupin in Q1, with a recovery seen only in the second half of FY19 as new generic products roll out. A ramp-up in on-market products like Solosec in the US and a smooth run to launch for biosimilar Enbrel in Japan and the EU, among other products, could be vital to restore momentum for the Indian firm.