Hyderabad: City-based CRAMS (contract research and manufacturing services) provider Divis Laboratories on Monday announced that the recent import alert issued by the United States Food and Drug Administration (USFDA) on the products manufactured at its Unit -2 at Visakhapatnam in Andhra Pradesh came as a 'surprise' to the company. The move is likely to impact 5% of its sales.
"We filed CAPA (Corrective and Preventive Actions) in our detailed response to the five observations and committed to further file additional information by January 31 and one more submission by March 31. The January filing has since been done and the March filing will happen this week. The import alert came as a surprise as, to our understanding, usually an import alert is issued after a warning letter and if issues or concerns raised are not addressed to the satisfaction of the FDA," Divis Laboratories chairman Murali K Divi said at a investor conference call conducted on this issue on Monday. Divi added that the company is still awaiting communication from USFDA on its 483 response and remediation plan. The US drug regulator had inspected the company's Unit-2 in December 2016 and issued a Form 483 with five observations. Following this, USFDA had also issued an import alert last week. According to the USFDA website, an import alert is issued when it has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations The US drug watchdog, while issuing the import alert on the Unit 2, had exempted 10 products namely -Levetiracetam, Gabapentin, Lamotrigine , Capecitabine, Naproxen Sodium, Raltegravir potassium, Atovaquone, Chloropurine, BOC Core Succinate and 2,4-Wing Active Ester. "The FDA has given exemption for a majority of our products based on their own evaluation of shortage of the drugs. We and our customers will also be approaching the FDA for exemption of a few more products, both in the custom synthesis and generic segments," Divi added.
Meanwhile, he said the company has engaged consultants for advising it on the 483 responses and remediation efforts. Divis Laboratories clocked a consolidated total income of Rs 3,776 crore and profit of Rs 1,112 crore for the 2015-16 fiscal. Established in 1990, Divis has two manufacturing units, including Unit-1 is built on a 500-acre site in Hyderabad and comprises of 13 multi-purpose production blocks. Its second manufacturing facility is located at Visakhapatnam (Unit-II) over a 350-acre site and has 14 multi-purpose production blocks.
Source: timesofindia.indiatimes.com