Cipla's Patalganga facility gets a form 483 with six observations from USFDA

 The United States Food & Drug Administration (USFDA) has issued a form 483 with six inspectional observations to Cipla Ltd.'s manufacturing facility at Patalganga in Maharashtra, it said in an exchange filing.

The US drug regulator had conducted a routine current Good Manufacturing Practices (cGMP) inspection at the said facility between March 28 to April 4, 2024.

Cipla said that it will work closely with the USFDA and is committed to address these observations within the stipulated timeframe.

Cipla's Patalganga plant manufactures both Active Pharmaceutical Ingredients (APIs), which are the key raw materials for medicines, as well as formulations.

Shares of Cipla ended 0.9% lower at ₹1,458.05. The stock has risen 62% over the last 12 months.