Ranbaxy Laboratories has filed a complaint against the US Food and Drug Administration (USFDA) in D.C. federal court and has also asked the Court for a temporary restraining order to prevent any further action by USFDA until Ranbaxy’s case is decided. The pharma major has filed a complaint following, and in response to, the revocation of Ranbaxy’s tentative approvals for Ranbaxy’s ANDAs for esomeprazole magnesium delayed-release capsules and valganciclovir hydrochloride tablets.
Earlier this month, the USFDA withdrew its decision to grant tentative approvals to Ranbaxy for the two generic drugs citing the compliance status of Ranbaxy production facilities. The regulator had stated that its original decisions were in error because it found Ranbaxy’s plants at the time were not compliant with the regulatory norms.
Ranbaxy Laboratories is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.
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