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API

Latest Headlines

Latest Headlines

Rollout of openFDA continues with drug labeling, medtech adverse event APIs

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.

Hospira completes Orchid plant takeover to boost API supply security

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.

More consolidation in the API market as Provence picks up peptidemaker Synprosis

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.

SeQuent continues to build Indian API assets with Arvee acquisition

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.

GSK plans to unload site of closed Indian API plant

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.

Kyowa Hakko Kirin finishes $60M biologics API plant

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 authority withdraws Ranbaxy plant export permit

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.

GSK recalls Paxil after FDA issues warning letter

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.

Source: Ranbaxy shops for Nexium API to salvage lucrative launch

Making drugs requires ingredients--and that is what Ranbaxy Laboratories has been struggling with since the FDA banned its key active pharmaceutical ingredient (API) plant in January

Google-backed genomics alliance details data interoperability plans

The Global Alliance for Genomics and Health was thrust into the headlines last week when Google joined its ranks. This week it met for the first time to discuss its goals. Development of an open-source public application programming interface (API) for sequencing reads and genetic variants is high on the agenda.