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API

Latest Headlines

Latest Headlines

Belgian company investing in Indian API plant

Indian drugmaker Dr. Datsons Labs has told the Bombay Stock Exchange it expects a $17 million investment from a Belgium-based nutraceutical maker which wants access to one of its API facilities. According to  VCCircle, the structure of the deal was not disclosed in the filing but Dr. Datsons said Eubage Laboratory intends to invest in its manufacturing operations and also outlicense 20 of its products to the Indian drugmaker.

India's Himachal Pradesh state eyes foreign investment in bulk drugs

India's state of Himachal Pradesh, known as Asia's pharmaceutical hub, is taking steps to make its bulk-drug industry more attractive to foreign and other investors, but finds attempting to do so a hard slog. The action, and that of other states, is considered key to reducing India's reliance on imports of active pharmaceutical ingredients, mainly from China.

China's Novacyl Wuxi gets FDA warning letter

The FDA has issued a warning letter to a Chinese plant that makes active pharmaceutical ingredients for having suspect testing data after finding a failed test result in the trash and discovering the computer record of it had been overwritten. The letter comes as the agency is working to get more inspectors into the country, which has become the go-to producer of cheap APIs for the global market.

Pozen gets a second CRL as its API supplier awaits FDA reinspection

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 recalls Paxil tainted at GSK plant

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.

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.