New Delhi: Ranbaxy Laboratories Ltd, India’s largest drug maker by revenue, moved a step closer to its rehabilitation in the US market after the Food and Drug Administration (FDA) commenced a validity assessment at one of the its manufacturing plants, two people close to the development said separately.
If the assessment is successful, it could reopen the review of applications for the export to the US of Ranbaxy’s generic drugs manufactured at the disputed plant in India. In February 2009, the regulator had halted the review of all pending and new generic drug applications from the company’s Paonta Sahib facility in Himachal Pradesh.
“The FDA has begun a validity assessment at Ranbaxy’s Paonta Sahib plant and will conduct the assessment ANDA (abbreviated new drug application) by ANDA. This is the first time that FDA has undertaken any assessment of Ranbaxy’s plant since it invoked its application integrity policy (AIP) in February 2009,” said a person closely associated with Ranbaxy. He did not want to be identified.
ANDA is the submission of a generic drug for review by FDA ahead of marketing it in the US. Separately, another person also confirmed this, adding that the resolution, however, could still take long.
“Ranbaxy continues to cooperate with the US FDA and is making positive efforts to resolve the issue,” said a Ranbaxy spokesperson.
The US regulator declined to comment. “FDA does not provide comment on ongoing investigations,” said spokesperson Christopher C. Kelly in an emailed response.
Mint was unable to independently ascertain exactly how the assessment was being conducted, and what stage of resolution it was at.
As per a model FDA letter, the authority revokes AIP, the notice that halts all scientific review of ANDAs, after it conducts a validity assessment inspection of a firm and determines that it has implemented the commitments made in its corrective action plan.
“This is huge. If indeed it is a validity assessment inspection that FDA is conducting. It could well be the last leg of FDA’s inspection of Paonta Sahib. FDA may also want to speed up the process due to the approaching patent expiry of Pfizer’s blockbuster statin Lipitor,” said a Mumbai-based analyst who didn’t want to be named.
Once FDA invokes its AIP, the firm is required to hire, in consultation with the regulator, a third-party consultant who prepares the corrective action plan as required by FDA. This plan has to be approved by FDA and then implemented, following which it is assessed by the regulator. Ranbaxy had hired US-based Quintiles Transnational Corp. as its consultant.
Ranbaxy’s troubles with FDA began in September 2008, two months before its acquisition by Japan’s Daiichi Sankyo Co. Ltd was completed, when the regulator issued warning letters to two of its manufacturing facilities in India—Paonta Sahib and Dewas in Madhya Pradesh.
FDA had blocked the import of 30 generic drugs from these two facilities to the US following which it had also invoked the AIP on Paonta Sahib.
“Ranbaxy management has maintained for over two quarters now that they have completed all compliance work at the two plants and are now awaiting FDA’s visit. The firm also needs to give some clarity to its customers by June-July on whether it will be in a position to launch the generic version of Lipitor in the US under its exclusivity period so that the customers can reduce or increase their inventory accordingly,” said the analyst cited above.
Ranbaxy has also consistently maintained that it will monetize all of its exclusive products—the generic version of Lipitor is the company’s biggest product. Ranbaxy is scheduled to launch it in the US on 11 November, which will happen simultaneously with Watson Pharmaceuticals Inc., the authorized generic manufacturer.