- The FDA has sent a warning letter to Zydus Cadila, a large Indian pharmaceutical company, regarding GMP violations at two of its plants—its Moraiya formulation facility and its Ahmedabad-based Zyfine API facility. Both facilities are located in the Gujarat region.
- Cadila filed notice of the warning with the Bombay Stock Exchange. The FDA sent its letter on December 23, citing failure to adequately investigate out-of-specification laboratory results related to warfarin sodium tablets as well as failure to establish procedures for monitoring API processing.
- Although Zydus Cadila has received warnings before, it has maintained a fairly good reputation for manufacturing site regulatory compliance.
In Cadila's filing with the Bombay Stock Exchange, the company clarified that no products in the US market use APIs from the Zyfine facility. Cadila further promised to respond to the FDa with tin the statutory time permitted.
The FDA warned Cadila the agency may withhold approval of any new applications listing Cadila as a manufacturer and may refuse admission into the US any articles manufactured at the Moraiya and Ahmedabad plants. The agency did ask for further documentation of monitoring process along with the provision of a corrective plan.
Over the last five years, Zydus Cadila has received a handful of violation letters, including a letter for the same plant in Moraiya that is currently a source of concern. However, aside from these warnings, Cadila has been relatively violation-free compared to other Indian giant Sun Pharma, which has been a frequent recipient of regulatory warnings.
Zydus Cadila is also known for its development prowess with biosimilars. Last December, the company notched a major win when it became the first pharmaceutical company to receive regulatory approval for biosimilar Humira (adalimumab).