Drugmaker Pozen says its API supplier has done everything the FDA asked after noting issues in an April plant inspection and the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline and are part of a larger recall for which the FDA spanked GSK.
Having committed to a fast rollout of APIs at the start of the summer, the FDA made good on its promise this week by making data on drug labeling available. And the regulator went beyond its initial commitment by releasing an API for medical device adverse events.
The $218 million takeover gives Hospira an API plant and 665 staff in Aurangabad, India, furthering its ambition to become less reliant on third-party ingredient suppliers.
There is more movement in the active pharmaceutical ingredient manufacturing market, this time in France, where peptide specialist Synprosis was snapped up by fine chemical maker Provence Technologies Group.
Over the past 18 months, India's SeQuent Scientific has won FDA approval of its API plant, sold its specialty chemicals business and acquired a stake in Shasun Pharma. The Bangalore-based business is maintaining the pace and further bolstering its API production business by agreeing to buy Arvee Synthesis.
GlaxoSmithKline closed an aging active pharmaceutical plant in Thane, Maharashtra, India, a couple of years ago and let go of more than 300 people who worked there. Now, the British drugmaker would like to unload the property.
Japanese drugmaker Kyowa Hakko Kirin, which develops its own drugs and is in a partnership with Fuji to make biosimilars, has completed construction on a new active pharmaceutical plant for biologics.
Indian authorities, who have been criticized for turning a blind eye to serious problems at Ranbaxy Laboratories plants there, have stopped a Ranbaxy API plant in Toansa from being able to sell products outside of India.
GlaxoSmithKline has said it will recall some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been tainted. But the U.K.-based drugmaker didn't decide to take the step until it was publicly chastised by the FDA about the problem in a warning letter.