Early Last week the US arm of Indian drugmaker Ranbaxy pulled several batches of atorvastatin after tests revealed that the pills could contain small glass particles.
Ranbaxy subsequently halted manufacture of the drug at its plant in Princeton, New Jersey in order to identify the source of the problem.
A spokesman told in-Pharmatechnologist.com the move only affects the US market and “includes 41 lots of Ranbaxy label/ manufactured atorvastatin 10 mg, 20 mg and 40 mg tablets. It does not affect or relate the 80 mg tablets. The recall will cause temporary disruption to that market of this product.
He also said that: “The investigation with regard to the same of this issue is expected to be completed within two weeks and thereafter the Company expects to resume supplies.”
Ranbaxy’s comments fit with the predictions of ISI Group analyst Ross Muken who said in a note to investors the manufacturing halt is bound to affect supplies, given the Indian firm’s standing in the generic Lipitor market.
“Ranbaxy is the largest supplier of generic Lipitor, one of the US's most widely utilized drugs, with an ~60% market share as of 3Q'12. Given its dominant share of this high volume drug, we are certain to see supply shortages over the next two weeks.”
Muken questioned with alternate suppliers – such as Wastson Pharmaceuticals – have sufficient inventory to pick up the slack or even if they will see the stoppage as an attractive enough opportunity.
“The aggressiveness of other manufacturers is likely to be determined by the length at which Ranbaxy's product is removed from the market as the pricing dynamics in this market may not warrant a near-term step up in production if the time period is likely to be brief.”
The atrovastain recall is the latest in a long line of manufacturing problems for Ranbaxy. In December last year the Food and Drug Administration (FDA) issued the firm with a consent decree following year of wrangling about the quality of drugs produced for the US market at sites in India.
More recently – in August – Ranbaxy withdrew 27 abbreviated new drug applications (ANDAs) for drugs made at the Indian plants.