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.
Three plants owned by contract packaging maker Alcan have been cleared to produce containers for pharmaceutical products under the International Organization for Standardization’s ISO 15378:2006 guidelines.
Daiichi Sankyo, the Japanese drug firm that bought a controlling stake in India’s Ranbaxy last year, says it had no knowledge of FDA concerns that led to a block on ANDA reviews for drugs made at the latter’s Paonta Sahib facility.
Ranbaxy’s problems with the US FDA were ratcheted up a notch yesterday when the agency halted its review of products made at the firm’s plant in Paonta Sahib, India after uncovering “untrue statements” in ANDA’s and NDA filings.
An active pharmaceutical ingredient (API) pilot project, implemented by the Pharmacopoeial Discussion Group (PDG) last summer and aimed at harmonising API monographs, should generate its first results before the end of the year.
Barack Obama’s support for R&D tax credits to boost innovation is designed to assuage Big Pharma’s fears about a ban on “authorised generics,” and new “comparative effectiveness" tests, according to Datamonitor’s Sandra Reynolds.
Indian process technology firm ACE Technologies has won the contract to sell and service GEA Pharma Systems’ range of Courtoy tablet presses to local drug manufacturers as part of the latter company’s Asian expansion plan.