New player Hikal offers gabapentin
US-based pharmaceutical company to supply gabapentin, set to lose
its patent protection.
India's Hikal has entered into an agreement with an unnamed US-based pharmaceutical company to supply gabapentin, a $2 billion (€1.76bn) antidepressant that is going off patent.
Hikal has set up a Rs 30-crore (€5.7m) plant in Bangalore to manufacture active pharmaceutical ingredients. The facility is compliant with ISO 9001 standards, is World Health Organisation and Therapeutic Goods Administration (Australia)-compliant and is now awaiting US Food and Drug Administration (FDA) inspection, according to Business Line of India.
Although Hikal's primary business has been in agrochemicals, it has recently expanded its scope to include pharmaceutical APIs in the hope of grabbing generic drug export opportunities to the US market.
In addition to gabapentin, the company's range of products includes acebutolol HCI, bupropion HCI, buzepide, methiodide, cinnarizine, clocinizine dihydrochloride and flunarizine HCI.
Gabapentin is the generic equivalent of Pfizer's Neurontin brand, which generated sales of over $2 billion last year and is used in the treatment of epilepsy and post-herpetic neuralgia.
Although the identity of Hikal's customer has not been divulged, the US Food and Drug Administration's website lists five companies that have filed for approval of a generic version of the drug, namely Eon Labs Manufacturing, IVAX Pharmaceuticals, Purepac Pharmaceuticals, Teva Pharmaceuticals and Torpharm.
