Sun Pharma’s Halol Unit Gets An All-Clear Signal From U.K. Drug Regulator

Sun Pharmaceutical Industries Ltd.’s Halol unit has received clearance from the U.K.’s pharma regulator, ensuring continued sale of its products from the Gujarat plant in the European market, a person close to the development told BloombergQuint on the condition of anonymity.

The clearance means that the company complies with the good manufacturing practices set by U.K’s Medicines and Healthcare Products Regulatory Agency. Sun Pharma declined to comment on the clearance.

The plant, however, still faces regulatory issues from the U.S. Food and Drug Administration. Clearance from the U.K. drug regulator provides confidence that a future U.S. FDA inspection can be conducted smoothly and may result in a positive outcome, a company official said on the condition of anonymity.

“Bringing Halol back in compliance is the most important priority for us,” Sun Pharma Promoter Dilip Sanghvi had told analysts at the conference call this month after announcement of June quarter earnings. “Till there is no successful completion of the re-inspection, we will not get any approvals from this unit”, he had said.

The U.S. FDA last inspected the plant in the third quarter of financial year 2016-17 and raised nine observations for failing to prevent microbiological contamination and not meeting with testing design standards. The company, at its post-earnings conference call, had informed analysts that remedial steps to address these observations were complete and added that they were awaiting U.S. FDA to reinspect the Halol unit.

Shares of Sun Pharma rose as much as 3.5 percent on Monday compared to 1.4 percent intraday rise in the NSE Pharma Index.