After issuing an import alert last year for an IPCA Laboratories API plant in India where employees had been falsifying drug testing results and deleting failed tests, the FDA began looking at its operations further upstream and has now banned products from two of IPCA's finished product facilities.
India's government has threatened to place restrictions on imports of nonessential items, including pharmaceuticals, from China if it does not ease some of its "protectionist tendencies" toward India products.
Norwegian drugmaker Weifa figures its consumer health biz and its contract active pharmaceutical ingredient operations both have a better shot at growth if they go their separate ways. To make that happen, Weifa plans on spinning the API business off into a contract manufacturing operation, with its first contract to make the APIs for Weifa.
The FDA has cited a Novacyl active pharmaceutical ingredient (API) manufacturing plant in Thailand with a warning letter after finding some of the same issues there that it had uncovered at the company's facility in China.
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.