Earlier this month, Sun Pharma had recalled around 5,000 units of 10 ml vials of testosterone cypionate injections from the US that were made at the Halol facility. The product had presence of particulate matter in the vials.
According to analysts, recalls usually do not trigger immediate inspections, however, given that the plant was under regulatory scanner until recently, it is possible.
“The plant was last inspected by the USFDA in February and it is too early for a surprise audit. So, this can be a pre-approval audit for a specific product. The company has not shared details with us,” said
The Halol plant makes a variety of pharmaceutical products — from tablets to capsules and injectables to topicals (ointments). With the resolution of the Halol plant, experts expect the company could add $100-120 million in revenues annually. “Halol is an important plant for Sun Pharma,” said Shrikant Akolkar, pharma analyst with India Infoline.
The Halol site received an establishment inspection report in June from the regulator after an inspection that took place in February.
Soon after, the firm got the first product approval from the site, an oncology injectable Infugem. Halol’s non-compliance had held up fresh product approvals from the site for nearly four years and was partly responsible for the muted growth in the US for Sun Pharma.
The regulator had inspected the plant in 2014 and issued a warning letter in December 2015, following which Sun Pharma could not file for fresh approvals from the site.
Dec 2015: Issued warning letter to plant contributing to sales in high single digits
Dec 2016: Again made adverse observations
Feb 2018: Sun received three observations, down from nine
Jun 2018: USFDA stated compliance issues virtually resolved
Jun 2018: Plant gets USFDA’s establishment inspection report