Hyderabad: In a respite of sorts for city-based CRAMS (contract research and manufacturing services) player Divi's Laboratories, the US Food & Drug Administration (USFDA) has exempted some more products from the import alert it slapped last month on its Visakhapatnam facility.
Divi's on Saturday informed the bourses that "some more products manufactured at its Unit-II at Visakhapatnam have been exempted from the import alert issued under clauses 66-40 and 99-32 of the FDA regulations". The company's Unit-II in Vizag mainly manufactures active pharmaceutical ingredients (APIs) and intermediates for generics. While the company did not disclose the number of products exempted on Saturday, when contacted, company officials said another 11 products manufactured at the unit have been now exempted from the import alert, including one API (Carbidopa) and 10 intermediates (including CKE and DCam). Initially, in March 2017, USFDA had exempted 10 products while issuing the import alert namely -- Levetiracetam, Gabapentin, Lamotrigine, Capecitabine, Naproxen Sodium, Raltegravir Potassium, Atovaquone, Chloropurine, BOC Core Succinate and 2,4-Wing Active Ester. The US drug regulator had inspected the company's Unit-II in November-December 2016 and issued a Form 483 with five observations. Following this, USFDA had also issued an import alert in the third week of March 2017. 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 company top brass had, during an investor conference call on the issue on March 27, said the import alert had come as a `surprise' to the company and that the move was expected to impact just 5% of its sales. With the inclusion of more drugs in the exemption list, the impact of the alert will be further reduced, the company said. Established in 1990, Divis has two manufacturing units, including Unit-1 which is built on a 500-acre site in Hyderabad. Its second manufacturing facility is located at Vizag (Unit-II).
Source: timesofindia.indiatimes.com