Halol plant has got 23 regulatory observations, but chances of import alert are low
Sun Pharmaceutical Industries’ plant in Halol, Gujarat, has received 23 regulatory observations from the US Food and Drug Administration, a Credit Suisse report said.
But with the observations being related to procedural issues rather than data integrity, the chances of an import alert are low, it added.
This was possibly the reason Sun’s stock ended up over 4 percent on Friday on the BSE, at ₹807, observed another analyst, requesting not to be named. Sun did not comment on the report.
“Sun has received the 483 Form on the recent US FDA inspection of the Halol facility in Gujarat. During the inspection, the FDA team inspected the injectable unit, the oral solids unit and the quality control lab, which serves to both injectable and the oral solid unit,” the Credit Suisse report said.
Of the 23 observations, 10 were for the injectable unit, four for the oral solid unit and the rest for the quality control lab, the note said, adding the inspections happened earlier this month. “In our view, this facility accounts for 20-25 per cent of Sun’s profits.”
The FDA’s concerns are first raised with the company’s management as observations on a 483 form.
The issue will be put to rest if the company is able to satisfy the queries. Failing this, the issue could escalate to a more serious warning letter.
Observations
The report further pointed out that the regulatory observations included several procedural issues “where a resolution could take time and till then, approvals could be blocked possibly (it can impact growth as the fastest growing division for Sun is its US sales from the Indian plants).”
At the injectable unit, most observations are centered on aseptic procedures, the report said. The FDA had pointed out that contaminated vials were rejected without an assignable cause and the process to remove contamination was not defined within a “validation master plan” and ‘risk assessment process’.
Also, no procedures were in place to document which personnel were given access to the production equipment, the report said.
At the solid dosage unit, the US regulator noted that there were no standard challenge test articles used for routine performance checks of Blister pack machine and for the two recalls (Metformin ER and Venlafaxine ER), there was no formalised corrective action plan.
On the quality control lab, the report said the key observation was not extending investigations of an unexplained discrepancy to other batches of the same drug or other drugs that may have been associated with the specific discrepancy. Business Line
