Two approvals in a week for drugs made at Ranbaxy’s New Jersey OHM Laboratories subsidiary have eased the generics firm’s North American regulatory woes and strengthened its position in the expanding US market.
The US Food and Drug Administration (FDA) deemed that ramipril and quinapril HCl are bioequivalent to reference products, King Pharmaceutical’s Altace and Pfizer’s Accupril, and granted Ranbaxy marketing authorisation.
Company VP of sales and distribution Jim Meehan said: "This is the third ANDA approval granted by the FDA…in the last two months,” the first being for sumatriptan, a non-branded version of GlaxoSmithKline’s (GSK) blockbuster migraine drug Imitrex.
Meehan added that quinapril HCl tablets and ramipril capsules across a range of dosages will be made available in the country in the near term, but did not specify a launch date.
The US approvals are undoubtedly a vote of confidence for Ranbaxy’s North Brunswick facility that has been subject to particular scrutiny in recent years, including a federal raid in 2007.
The clearances also bolster Ranbaxy’s position in a US generics market that most observers expect to grow in line with impending blockbuster patent expirations and the regulatory changes proposed by the Obama administration.
However, Ranbaxy’s wider problems with the FDA regarding its Indian facilities remain. Early last week, the FDA halted its review of all drugs made at its plant in Paonta Sahib, India accusing it of submitting “untrue statements” on stability records.
Days later Health Canada followed suit, imposing a quarantine order on all drugs made at the facility until further notice.
This latest bad news for Paonta Sahib, which was already the subject of an FDA import blockade, led Ranbaxy’s Japanese parent company Daiichi Sankyo to step into the fray last week and form a joint team to address the problems.
Australia approves 26th Ranbaxy drug
In more positive news for Ranbaxy and Japanese parent Daiichi Sankyo, Austrialia’s Therapeutic Goods Administration (TGA) has cleared Ranbaxy’s sebifin terbinafine tablets
The drug, which is generic version of Novartis’ antifungal Lamisil, is made by Ranbaxy’s local subsidiary and is the 26th molecule that the firm has been cleared to sell in Australia since it was incorporated in 2004.