Ipca halts API shipments to US following 483 at Indian plant
In a letter to the Bombay Stock Exchange, the company announced today its Ratlam plant in the Madhya Pradesh region of India received a form 483 citing an undisclosed number of observations from a recent inspection by the US Food and Drug Administration (FDA).
“Consequent to this, the Company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till [sic] this issue is addressed,” the letter signed by Joint Managing Director Ajit Jain said.
The decision will affect the firm’s formulation business as APIs made at the plant – which according to Ipca’s annual report was expanded in the 2013/4 financial year – are used at Ipca’s sites in Piparia and Indore (both in India) for formulating products for the US market.
Share prices for the firm dropped 13% across the course of Thursday following the letter’s submission to the stock exchange.
In-Pharmatechnologist.com contacted Ipca by phone and email but received no comment at the time of going to press. However, Jain’s letter said the firm “is fully committed in resolving this issue at the earliest.”
The API business accounts for almost 25% of Ipca’s revenues, according to its website which lists 57 commercial substances with Drug Master File (DMF) available in the US manufactured from its six Indian sites.
The voluntary decision to halt production to the US comes in light of a surge in enforcement by the FDA, who in the past year has hit a number of large manufacturing sites in India – including plants run by Ranbaxy, Sun Pharma, Apotex and Wockhardt – with 483s, Warning Letter and consent decrees due to cGMP violations.
