Indian API maker Ipca Laboratories sent an email filing today alerting the Bombay Stock Exchange (BSE) it has received a Warning Letter from the US Food and Drug Administration (FDA) citing manufacturing compliance issues at its facilities in Ratlam(Madhya Pradesh), Indore (Pithampur) and Piparia (Silvassa).
But in-Pharmatechnologist.com was told the letter highlights no issues for the company that the FDA did not cite in a Form 483 from 2014, mostly relating to laboratory practices and staff training across the three sites.
“We were wondering why the FDA letter was taking so long to come,” a spokesman said. “Finally it has come and there is nothing new in it.”
The July 2014 inspection centred on failures to record aborted test batches, he continued and “the character and the way people in the facilities carried out the work.”
This led to a voluntarily suspension of production at the Ratlam plant, and subsequent US import alerts across all three sites. The number of observations has not been divulged.
However, we were told the firm has already external consultants as part of its remediation efforts, and with the problems having already been rectified, Ipca is now just awaiting a reinspection by the FDA.
For the remediation efforts itself, “no substantial capital investment was required,” the spokesman said, but the production halt and import alerts has adversely affected Ipca’s financial results.
Nearly 25% of Ipca’s turnover comes from API exports, the company says on its website, but while the firm had been seeing double-digit annual growth from 2005 to 2013, the regulatory issues caused FY 2014-15 sales to be flat at around 31bn INR ($470m).
“We were at around 16% CAGR,” we were told. “However, we lost the opportunity to continue this growth.”