Latest Sun Pharma recall blow for firm
pharmafile | May 9, 2014 | News story | Manufacturing and Production | Caraco, Cetirizine, Effexor, FDA, Sun Pharma, recall
India’s largest drugmaker Sun Pharmaceutical Industries is recalling almost 400,000 bottles of anti-depressant and antihistamine medications in the US, because the pills failed to dissolve properly.
Around 128,000 bottles of Sun Pharma’s Cetirizine, the antihistamine, “may not meet the drug release specification through expiry”, the FDA says in a statement.
On top of this, 252,000 bottles of generic Effexor, called venlafaxine and licensed for depression, have been recalled. These are distributed by Sun’s US arm Caraco Pharmaceutical Laboratories, and are manufactured in Gujarat, India.
The recalls are the latest in a string of incidences by Indian companies that have led to increased scrutiny from regulators, concerned that the quality of drugs made in that country aren’t up to US standards.
The concerns prompted FDA commissioner Margaret Hamburg to go to India in February to meet with pharma manufacturers in order to discuss production problems, and attempt to shore up quality.
But in March the US imposed a ban on imports from a division of Sun Pharma, saying that the unit was not “operating in conformity with good manufacturing practices”.
Overall the FDA has put more than 30 Indian manufacturing units on its ‘import alert’ list, something that can stop products from entering the US.
This latest recall also comes just as Sun is in the middle of a controversial $4 billion takeover from fellow Indian native drugmaker Ranbaxy, that specialises in producing generic medicines.
The deal should close by the end of the year but hit a major roadblock last week when an Indian court temporarily stopped the sale of Ranbaxy to Sun after concerns were raised over insider dealing.
The Financial Times says the Andhra Pradesh High Court has ordered that the deal be put on hold while judges rule on petitions, which are requesting an investigation into whether any insider trading of Ranbaxy shares took place.
Ben Adams
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