- Regulatory compliance issues at Sun Pharma's Halol manufacturing plant in Gujarat, India continue to bedevil the large drugmaker, even after a yearlong remediation effort aimed at fixing GMP violations flagged by the Food and Drug Administration in a 2015 warning letter.
- In a notice to India's National Stock Exchange dated Dec. 8, Sun revealed the FDA had issued a Form-483 citing nine "inspectional observations" following the completion of an inspection at the Halol site.
- Sun said it is preparing responses to the observations, which the FDA would take into account before deciding on any subsequent action.
The FDA's latest inspection, conducted between Nov. 17 and Dec. 1, came at the request of Sun Pharma, which hopes to resolve the 2015 warning letter.
News of the forthcoming Form-483 led to a sell-off of the drugmaker's stock on Indian exchanges, according to a report from Bloomberg.
The Halol site is crucial cog in Sun's manufacturing network, responsible for production of the company's injectable products. U.S. sales of drugs produced at Halol account for a "high single digit" percentage of Sun's total sales, according to an update from Dilip Shanghvi, managing director of Sun, last year.
But since a September 2014 inspection —which resulted in the December 2015 FDA warning letter — the FDA has withheld approvals for products coming from the facility. Getting Halol back on line, then, is important both to the company's bottom line and its efforts to expand market share in the U.S.
The Form-483 is not yet public and Sun did not characterize any of the new observations cited by the FDA.
In the December warning letter, the regulator cited flaws in the company's procedures to prevent microbiological contamination and maintain aseptic conditions. Sun also did not adequately investigate out of specification batch results and lacked appropriate audit trails on its computer and production systems.
A new warning letter, if issued, may catch Sun flat footed. In a conference call on Q1 earnings (which covers the 3 months ended June 30 for Sun), Shanghvi said the company didn't have any back-up plan in place for the Halol site failing its re-inspection.
"I do not think that we have a Plan B on not passing the re-inspection because I think we have worked hard to address all the compliance related anxieties or issues which were raised," Shanghvi said.
Sun said it would reply to the FDA's new observations within 15 days.