US Food and Drug Administration (USFDA) has issued warning letter to Lupin’s Maharashtra-based active pharmaceutical ingredients (API) plant. The US health regulator has pulled up the company for manufacturing lapses, including failure to establish adequate written procedures for cleaning equipment, at its Maharashtra-based plant. This warning letter summarises significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. In the warning letter the health regulator pointed out the company's failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
