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Ranbaxy, Wishful Thinking and the Fudge Factor


FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."

But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?

From 'On Pharma'

FDA: Ranbaxy Falsified Data


Here's the latest chapter in this saga. For more background on the developments of this story, visit our old posting.

--PWT

From 'On Pharma'

Ranbaxy Relief


A nice, if brief, Q&A appeared today in India's Business Standard, featuring a conversation with Arun Kumar, CEO of generics maker Strides Arcolab.

From 'On Pharma'

Contemplating the Dr Reddy’s Model


There's been a lot of discussion lately about what the new generics model will look like, now that the "Ranbaxy model" has gone out of favor (see our recent article) and major generics manufacturers have begun partnering with major branded drugmakers (and vice versa) in an effort to create synergies and economies of scale. After decades of vitriolic competition between generic and branded, it seems like both sides are taking the "If you can't beat 'em, join 'em" route.

Dr Reddy's Laboratories, India's second largest pharma company to Ranbaxy, has been mentioned as a possible merger/takeover target. But maybe Reddy's has a better model in mind, one that broadens the focus of its products and services based upon the expertise it already has in house. After all, the manufacturer has amassed a huge pool of talent and expertise over the last few decades. The company has announced plans to capitalize on this intellectual capital by expanding the services that go along with the research and manufacturing it performs. It makes sense, given the fact that many multinationals are outsourcing these functions.

Reddy's may not always go it alone, but it will appear all the more attractive should a suitor come along.

--PWT

From 'On Pharma'

Ranbaxy Denies Any QC Issues, Data Manipulation or Adulteration of US Product


The story, click here for our version (one of thousands circulating) ----which explains the Valentine's Day inspections at Ranbaxy's U.S. headquarters last year---  has been generating a lot of buzz this week. Also mentioned in the allegations is Parexel Consulting, the consulting arm of contract manufacturer Parexel, which had a huge presence at DIA this year. Both deny any wrongdoing.

 Here's how Indian television news covered the story earlier this week. 

From 'On Pharma'