Gemfibrozil Manufacturing Problems at Sun’s NJ Facility Among Issues Prompting FDA Warning Letter

Gemfibrozil manufacturing problems resulting in imploding sample bottles and unknown impurities and how they were responded to were central concerns highlighted in an FDA warning letter to Sun Pharmaceuticals in late August regarding inspection findings at the Indian generic drug company’s Cranbury, New Jersey facility.

During the inspection that stretched out from late February until late April, a prominent focus was the manufacturing process for Gemfibrozil tablets that the warning letter asserted is “not capable of producing batches of consistent quality.”  Gemfibrozil is a generic version of Pfizer’s cholesterol-lowering drug Lopid.

In line with FDA’s growing concern with excipient supply chains, the FDA investigators focused on the correlation between the Gemfibrozil manufacturing problems and a change in magnesium stearate supplier.

The investigators found that three scale-up validation batches and three production batches had experienced “sticking and picking” defects during compression and packaging.  By contrast, these issues were not seen by Sun in two exhibit batches produced earlier which used magnesium stearate from a previous supplier.

Sun audited the second magnesium stearate supplier after experiencing the manufacturing issues and found “significant deficiencies,” which in part resulted in the firm changing back to its original supplier.  The warning letter notes that, in its response to the 483, Sun had not provided a plan to ensure that ingredient suppliers for all of its drug products are “adequately qualified.”

[Subscribers can go to here for further analysis of the issues raised by FDA at the Cranbury facility and an update on the compliance problems Sun has also been having at its Michigan-based Caraco subsidiary as well as links to relevant documents.]