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.
Lupin is now allowed to sell off up to 49% of the company--if it decides it wants to--in a deal or deals that could be worth more than $1 billion. At Lupin's request, India's Cabinet decided to raise the cap on foreign investment in the company; previously, Lupin was allowed to sell up to a 33% stake.
Merck is investing €80 million ($107.67 million) in a new plant in China to make treatments for diabetes and other conditions and to realize its aspirations there. But it appears it is looking to India as a way to cut production costs on some of its older products.
Salix Pharmaceuticals, which has its hands full with a tax inversion merger and the integration of Santarus, will hand off Canadian sales of some of its drugs to India's Lupin. The package includes Salix's opioid constipation drug Relistor, a drug which has fallen far short of its initial potential.
Nilesh Gupta, managing director of India's Lupin, told Bloomberg that his company gave Wockhardt a financial sizing up recently before deciding it didn't represent a good M&A target.