API sales down 81% as Ranbaxy feels fallout from US import alerts

By Dan Stanton contact

- Last updated on GMT

API sales down 81% as Ranbaxy feels fallout from US import alerts
Ranbaxy has reported a 14% drop year-on-year of overseas revenues attributed in part to the voluntary suspension of shipments from its Toansa and Dewas facilities API facilities.

For the first quarter of fiscal year 2014-5, Ranbaxy announced consolidated sales of INR 23.7bn ($390m), comprising of INR 6.2bn worth of sales in India (up 12% year-on-year) and INR 17.5bn from overseas (down 14%).

The fall in overseas revenues was attributed to an 81% drop in sales of active pharmaceutical ingredients (APIs), mostly from the firm’s plants in Toansa and Dewas – both India – following regulatory clampdowns and a voluntary suspension of shipments still ongoing.

The Dewas plant was one of three hit with a US Food and Drug Administration (FDA) consent decree in 2012​, whilst Toansa received an import ban in January​. Whilst Toansa had its GMP certificate reinstated by the EMA in June​, the firm is still feeling the impact from the voluntary halt in production.

“I think over the period of next couple of quarters, we should see absolute normalization of these operations for our API business,”​ CEO Arun Sawhney said when asked in a conference call about possible timelines for the return of full production and shipping.

He continued, telling investors the firm was currently supplying to several markets around the world, both regulated and otherwise.

For the quarter, API sales stood at INR 466m compared to INR 2.3bn in the same quarter last year.

Sawhney also spoke of the administrative subpoena issued by the US Department of Justice (DOJ) in March this year, seeking further information as to operations at the Toansa plant.

“It is directed towards getting some documents and questions and some information relating to the Toansa import alert related matters,”​ he said. “It is not nothing more than that as far as our knowledge goes at this stage… whether it will develop further etc., we do not know [until] after we had provided the information to DOJ.”

Ranbaxy was bought by Sun Pharma for $3.2bn ​ in April.

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