Aarti Comments on FDA Import BanBy
Aarti Drugs Ltd, a pharmaceutical company and contract manufacturer based in India, has commented on an import ban issued by the US Food and Drug Administration (FDA) for its facilities in Tarapur, India. Aarti issued a statement through the Bombay Stock Exchange (BSE)
In a statement, the company said that two of the Aarti Drugs Ltd facilities in Tarapur received an import alert dated March 23, 2015 from the FDA as per the FDA website, but that only one of the facilities is a US FDA-registered facility as the second facility cited by the FDA had already been delisted a couple of years back.
For the E-22 facility for which an FDA import alert was issued, Aarti said in its statement that the facility had a re-inspection in August 2014. Post that, the company submitted four responses beginning in August 2014 and most recently in February 2015. “We still have to receive an official communication from US FDA on the import alert after which we can take immediate actions to rectify the same,” said the company in the BSE statement.
The company’s manufacturing facilities in India, Tarapur, (Maharashtra) and Sarigam (Gujarat), manufacture more than 50 bulk actives, several key intermediates, and speciality chemicals, according to company information.
The company added that for the current financial year 2014-15, total US sales contributed slightly less than 1% of the total sales volume so the import ban has limited financial impact..
Sources: Bombay Stock Exchange and US FDA