Intellectual Thoughts by Sanjay Panda


Ranbaxy US unit gets a violation notice

Ranbaxy Laboratories Ltd said on 24th Dec that's its wholly-owned US-based unit Ohm Laboratories Inc has received a warning letter from the US Food and Drug Administration (FDA) relating to violations of good manufacturing practices. The FDA letter, dated December 21, mentions violations at Ohm's liquid manufacturing facility in Gloversville, New York,

The FDA conducted site inspections at the plant in July and August 2009. Ohm Laboratories operates three US-based manufacturing facilities and sells generic and branded private label drugs in the United States.

Ranbaxy said the FDA inspected Ohm's other two plants earlier this year but did not observe any material deviations.Late last year, Ranbaxy had received a US ban on some of its products.

Glaxo has taken 19 % share of Aspen

GlaxoSmithKline has taken a 19 per cent stake in Africa's biggest generic drugmaker, Aspen Pharmacare, after completing a strategic collaboration with the South African group. Earlier Glaxo had originally said it would have a 16 per cent holding when the deal was announced in May.

Aspen has issued 68.5 million new shares to Glaxo in exchange for Glaxo's manufacturing plant in Bad Oldesloe, Germany, and eight specialist medicines.

Selling branded generic drugs in emerging markets is a central plank to diversify Glaxo's business away from its traditional reliance on blockbuster medicines in Western countries. In addition to the tie-up with Aspen, Glaxo also has deals with Dr Reddy's Laboratories and a number of Chinese partners.