US drug regulator inspects Sun Pharmaceutical's Halol plant in Gujarat

Sun Pharmaceutical Industries’ Halol plant in Gujarat, which was cleared in June by the US drug regulator, has been undergoing a fresh inspection, sources claimed. 

The company declined to comment on the matter. Analysts said that while it could be a surprise audit (given the plant’s history of regulatory issues), it could also be a pre-approval inspection (that usually happens before a product from that site is approved by the US drug regulator). Sources claimed a team of inspectors from the US Food and Drug Administration (USFDA) was at the facility to inspect the plant.  

The company stock was down 1.25 per cent on the BSE to Rs 621.8. 

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 
an analyst. 

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.
Under Scanner

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