Authorities in Europe have flagged a noncompliant China plant for 18 shortcomings revealed in a recent inspection, the latest in a series of crackdowns by Western regulators working to ensure the quality of drugs coming from Asian plants.
If the holes in the ceiling and walls allowing pigeons to fly around manufacturing equipment at India's Pan Drugs were not enough to warrant an FDA warning letter, then the fact that it also was not thoroughly testing its APIs did the trick.
Germany's leon-nanodrugs GmbH announced the closure of its €18.5 ($20.4 million) Series A preferred stock offering. The company develops oral and parenteral reformulations of generic active pharmaceutical ingredients using its patented MJR nanotechnology platform.
When drugmaker Pozen got a second FDA complete response letter tied to issues with its API supplier, the company insisted it had already done everything the agency asked.
Swedish contract drug developer Recipharm has signed a deal with Virginia's Synthonics, investing in the biotech and lending its expertise in the development of new compounds.
Indonesia drugmakers expect to emerge from a long period of a depressed currency to almost double industry sales this year, according to one of the pharma leaders.
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.