Sun recalls biosimilar brain treatment

Biosimilars/News | Posted 21/09/2012 post-comment0 Post your comment

India-based Sun Pharmaceutical Industries (Sun Pharma) is once again in the news, but for the wrong reasons.


On 28 August 2012 troubled generics drugmaker Sun Pharma announced that it had finally received FDA clearance to resume manufacturing at the company’s US subsidiary Caraco Pharmaceutical Laboratories (Caraco) facilities. FDA had been withholding approval of pending new applications for drugs produced at the Cranbury facility in New Jersey, USA, until Sun Pharma sorted out problems with good manufacturing practice requirements [1]. Sun Pharma’s two Michigan plants had been given permission to again manufacture two products, heart drug carvedilol and antibiotic paromomycin.

However, the company announced on 4 September 2012 that Caraco had to recall two lots of its nimodipine capsules due to the presence of crystals. The drug is a generic version of Bayer’s Nimoptop, a dihydropyridine calcium channel blocker, which are used to decrease problems due to subarachnoid hemorrhage (bleeding in the brain). The voluntary measure was made because, although no adverse events had been reported, the crystallisation of the nimodipine fill material in the capsule could adversely affect the product’s bioavailability. Although clinical health implications are unknown, use of the product when the nimodipine has crystallised in the capsule may be of great clinical significance, according to the recall notice.

The voluntary recall is unrelated to the production issues at the Caraco facilities, as the recalled capsules were manufactured for Sun Pharma by contract manufacturing organisation Pharmaceutics International. Despite this the timing could not be worse for Sun Pharma, who had finally managed to get the troubled Caraco facilities back on track after troubles dating back to 2009.

Related article

Sun Pharma’s US operations partially on track


1.  GaBI Online - Generics and Biosimilars Initiative. Caraco and Sun to merge []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Sep 21]. Available from:

Source: FDA, Sun Pharma

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