The US drug regulator is conducting a surprise audit at Sun Pharma Halol facility in Gujarat. The audit started on Monday and is still going on, sources told CNBC-TV18‘s Archana Shukla.
The US drug regulator has been conducting a surprise audit at Sun Pharma's Halol facility in Gujarat.
Sources say Sun Pharma was taken by surprise when a team of 5 US FDA inspectors walked in on Monday morning. Usually USFDA come for audits in smaller teams of 2-3 inspectors. The inspection that started on Monday is still ongoing.
Sources say USFDA inspectors in two teams are auditing both the injectibles as well as oral solids units at the plant, with one team focusing on manufacturing processes and other closely auditing quality control and assurance departments.
Reports suggest majority of ex-Taro products of Sun Pharma for the US market come from Halol facility. So, if sales from its subsidiaries Taro and URL are removed, analysts say nearly 300-400 million dollars of company's sales would depend on products manufactured at Halol. In that light, the USFDA audit and its results are important to note.
We however, have no update on what are the observations of the USFDA in this audit. There could just be minor observations noted and this turned into a regular audit, but, in case there is a serious observation, it would be negative for the company. However, this will be known only once the audit completes and USFDA issues the form 483 with its observations.
It is also important to note that analysts have in the recent past raised concerns about multiple recalls that Sun made from the US market of products made at Halol. A July 14 report by Credit Suisse had highlighted the possibility of an increased scrutiny.
Sun had recalled 40,000 bottles of Venlafaxine Hydrochloride extended-release tablets from the US market in July 2014. Reason noted was that stability results found the product did not meet the drug release dissolution specifications. 200 vials of the chemotherapy drug gemcitabine were recalled in July due to a lack of assurance of sterility. In March the company had recalled 2,528 bottles of metformin extended release tablets, when a customer complained that one of the bottles contained tablets of epilepsy drug Gabapentin.
Besides, Sun's other plant Kharkadi is under a USFDA import ban with serious deviations. USFDA in its warning letter on KIharkadi had asked the company to review all its global facilities for similar deviations.