In a filing with the Bombay Stock Exchange (BSE) on December 31, Cadila Healthcare – part of the Zydus group – said the warning received from the US Food and Drug Administration (FDA) related to its Moraiya formulation facility and Ahmedabad API facility (Zyfine), both in the Gujarat region of India.
Details of the GMP violations cited in the letter were not revealed, and in-Pharmatechnologist did not receive a response from the company at the time of publication, but according to the filing Cadila is working on resolving the issues raised by the Agency.
“The Company is working hard to ensure that the commitments made to the US FDA are fully completed,” the filing said. “The Company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facilities.”
The Moraiya site is one of four finished formulation plants operated by the Zydus Cadila group in India, while Zyfine is one of three API production sites.
According to the firm, there are no products in the US market which use APIs made at the Zyfine facility.
“We will respond to US FDA to address the observations within the statutory time permitted in the letter. We are committed to resolve all the issues and revamp our quality systems and processes as the top most priority.”
The Moraiya plant was hit with an FDA warning letter in 2011 after inspectors were concerned about microbiology practices at the facility, including issues with staff being “unable to accurately identify microbial growth on environmental monitoring plates” and failures in establishing written procedures designed to prevent microbiological contamination.
And in July 2014, the firm received a Form 483 citing concerns about bioequivalence studies carried out at Moraiya.
However, “though the Moraiya plant had received 483 observations and was under USFDA scanner, the warning letter of Zyfine facility has come as a negative surprise,” according to a stock update note from investor service ShareKhan. The note adds the plant does not contribute to Cadila’s US sales.