Informist, Wednesday, Aug 21, 2024

--US FDA assigns voluntary action indicated tag to Divi's Lab Unit-II

By Apoorva Choubey

MUMBAI – Divi's Laboratories Ltd's manufacturing facility near Visakhapatnam in Andhra Pradesh, known as Unit-II, has been cleared by the US Food and Drug Administration, records accessed by Informist showed. The facility has been assigned a 'voluntary action indicated' or VAI classification, according to records on inspections and citations on the regulator's Food Safety Modernization Act-related database.

The unit, located in Chippada village, produces significant quantities of active pharmaceutical ingredients and other products sold by the company, experts said. The US regulator had conducted an inspection at the unit during Jul 11-19, as part of general common good manufacturing practices – a cGMP inspection. The audit led to one procedural observation by the US agency.

Voluntary action indicated status means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action and is satisfied with the responses given by the company. No action indicated is awarded when a unit is found fully compliant, while official action indicated signals serious non-compliance and possible action by the US drug agency.

This facility is key to the company and clearance of this unit could spell good news for the drugmaker and its investors, according to experts. This is the same facility that was given a warning letter in 2017, following which the company's new approvals in the US suffered. The regulator had not only noted serious data integrity and quality control issues during the audit, but also said that the company tried to limit or refuse proper access to the inspectors.

The facility has been inspected by the US FDA eight times since 2009, data related to the establishment inspection number of this facility showed. The regulator has classified the unit as 'voluntary action indicated' five times and 'no action indicated' twice, except the one time it was classified as 'official action indicated' in 2017, when the warning letter was issued.

Some of these classifications may have been given retrospectively as the practice of these tags is fairly recent.

While the exact contribution from the specific unit could not be ascertained, the overall unit-II manufacturing facility, which comprises an export-oriented unit and three other units designated as special economic zones, has a capacity of 10,000 cu mtr, according to information on the website of Divi's Laboratories. The company's total manufacturing capacity is 14,600 cu mtr, as per the annual report for the last financial year ended March.

Divi's Laboratories reported weaker-than-expected earnings for Apr-Jun due to supply chain issues and higher inventory. The Hyderabad-based drugmaker reported a net profit of 4.30 bln rupees, up 24.6% year-on-year, on revenue of 20.63 bln rupees, up 19.3% year-on-year.

At 1458 IST, shares of the company were up over 3.8% at 4,907 rupees on the National Stock Exchange. The stock has gained 8% in the last 30 days and 25% so far in 2024. End

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

Edited by Avishek Dutta

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