India drug authorities are working on plans to increase the nation's capacity to produce its own bulk drugs in an effort to reduce its drug industry's dependence on imports, mainly from China.
Sixty-four jobs are at risk as a result of AMRI's proposal to close an API plant in Wales. A final decision for the plant will come after a consultation with employees and discussions on ways to reduce "redundancies" at the former Excelsyn facility.
In a conference call after reporting solid sales and earnings, Novo Nordisk CFO Jesper Brandgaard said the company expects to spend 5 billion Danish kroner ($767 million) this year to boost its capacity for manufacturing biopharmaceuticals and APIs and insulin filling, as well as some for new R&D construction.
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 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.
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.
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.