India's Lupin worked a license deal with Romark Laboratories a couple of years ago to handle sales in the U.S. of liquid diarrhea treatment Alina in the U.S., relying on its reps who handle sales of pediatric drugs. But some recent batches of the drug, often prescribed for children, are not up to specification, and so Romark is recalling them.
Continuing to spread its wings, India's Lupin now has a toehold in the Brazil market by buying Medquímica Indústria Farmacêutica, producer of branded, generic and over-the-counter drugs.
India's Lupin launched a generic drug tablet in the U.S. combining hypertension drugs Amlodipine and Valsartan tablets.The drug is a generic version of Novartis AG's Exforge tablets, Lupin said.
Shasun Pharmaceuticals stockholders gave their near-unanimous approval to a merger with Strides Arcolab, and Lupin said it would buy out all of South Africa's Pharma Dynamics.
Lupin expected to introduce 15 to 20 new products to the U.S. market this year, but that was before the announcement today that the FDA had found shortcomings at one of its key plants in India.
The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has done little to slow the rate of approvals for the facility, which has racked up two site transfer nods and one ANDA go-ahead since receiving the Form 483.
Indian drugmaker Lupin announced two separate developments in its asthma drug delivery segment, launching one product in the U.S. and signing a development agreement for a generic version of GlaxoSmithKline's Advair Diskus, which would be commercialized in North America and other markets.
FiercePharmaAsia rounds up company activity in Asia across pharmaceuticals, biotech and devices to stay abreast of deal making and provide insight on partnerships and disputes in the works.
India's Cipla argued before the Delhi High Court against the Novartis patent for its Onbrez (indacaterol) COPD drug, saying the patent need not be honored because the Swiss drugmaker was not working it in the country and has licensed it to Lupin instead.
SINGAPORE-- Despite missing its target for bringing 15 to 20 drugs to the U.S. market last year, Lupin is optimistic enough about 2015 that it seeks possible acquisitions in Russia to expand its presence there.