Pharma major Cipla has received a warning letter from the United States
Food and Drug Administration (US FDA) for the routine current Good Manufacturing Practices (cGMP) inspection conducted at its Pithampur manufacturing facility during February 6 to 17, 2023.
This warning letter summarises contraventions regarding methods or controls followed at the facility which do not conform to the prescribed cGMP regulations and contains directional guidance for necessary corrections.
The plant was issued eight observations by the US drug regulator for the inspection carried out earlier this year. In August, the facility was classified as Official Action Indicated (OAI).
The company will respond to the Warning Letter within the stipulated timelines and work closely with the US FDA to address the concerns in a holistic and timely manner to ensure sustained compliance, the company informed the exchanges. "We uphold quality and compliance with utmost importance and remain committed to be compliant with the cGMP quality standards," it said.
Earlier, the management had said that the US FDA observations at Cipla's plants in Pithampur and Goa were delaying the launch of products by almost six months in its Q2 press meet. The management had then said that the biggest product manufactured at the Pithampur facility was Advair and that they were in the process of shifting its manufacturing to Hauppauge in Long Island.
Advair, which is used in the treatment of asthma and chronic obstructive pulmonary disease, is expected to have significant revenue potential, with analysts expecting it to bolster Cipla's financials. The drug commands a market size of $700 million.