Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
The launch came after final approval from the US health regulator to manufacture the generic version of Lipitor at Ranbaxy's wholly owned Ohm Laboratories facility in New Brunswick, New Jersey, as well as market the product.
Ranbaxy Laboratories on Thursday said it had received Abbreviated New Drug Application approval from the US Food and Drug Administration to manufacture and market Loratidine
Earlier in April, Sun Pharmaceuticals Industries announced acquisition of Ranbaxy in an all-share deal.
The recalled drugs were manufactured and distributed in the US by Ohm Laboratories.
FDA inspectors visited the Mohali plant in the process of giving approval to Ranbaxy's application for Valsartan.
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
The recall is the latest in a series of problems to hit Ranbaxy, which has had all its India factories stopped from sending drugs and ingredients to the United States.
US country head, key departmental heads leave; more likely to follow.
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