23-Mar-2017 - Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.
22-Mar-2017 - The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.
22-Mar-2017 - Jinan Jinda Pharmaceutical Chemistry Co. Ltd has more to do to bring its drug ingredient plant in Shandong, China up to code according to the US FDA.
20-Mar-2017 - Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.
16-Mar-2017 - Axim Biotech has enrolled patients in its Phase II trial for Canchew Plus chewing gum – a delivery method with a “cumulative effect,” says CEO.
16-Mar-2017 - The US FDA has criticised Badrivishal Chemicals & Pharmaceuticals for failing to document production and monitor the efficacy of water purification systems at its API plant in Maharashtra.
15-Mar-2017 - The US FDA has slammed China’s Lumis Global Pharmaceuticals for problems documenting and labelling active pharmaceutical ingredients.
15-Mar-2017 - DSM Sinochem Pharmaceuticals has licensed enzyme-based antibiotic production IP to Sandoz and accused Sinopharm Weiqida Pharmaceutical of patent infringement.
14-Mar-2017 - Siegfried saw higher sales in 2016 thanks to the API business it bought from BASF and opening of new plant in China, but profits fell on integration costs and higher taxes.
09-Mar-2017 - Dr Reddy’s Laboratories says it is addressing the observations at its Duvvada plant which was hit with a warning letter in 2015.
08-Mar-2017 - A second Megafine Pharma plant has landed a US FDA warning letter for cGMP violations, including sourcing API intermediate materials from a facility on import alert.
08-Mar-2017 - Noramco has added cannabinoids to its portfolio of opioid APIs.
07-Mar-2017 - Former J&J controlled substance API unit Noramco is to rejig its business to cater for branded and generic drug firms and companies looking for formulation tech solutions.
07-Mar-2017 - The US FDA has told Wockhardt its quality issues are company-wide, citing problems at subsidiary Morton Grove as an example in a warning letter published today.
06-Mar-2017 - Keryx Biopharmaceuticals will continue to work with Norwich Pharmaceuticals despite bringing Patheon on board to manufacture Auryxia (ferric citrate).
06-Mar-2017 - The US FDA has warned Wockhardt Limited about operations at its US subsidiary Morton Grove Pharmaceuticals Inc.
02-Mar-2017 - The EU and US have agreed to recognize drug and API manufacturing plant inspections conducted in their respective territories under a deal signed this week.
02-Mar-2017 - The US FDA has cleared Akorn Inc. to sell a generic version of the immunosuppressant CellCept made at its plant in Decatur, Illinois.
02-Mar-2017 - Wacker Biosolutions says an excipient shown to increase the bioavailability of a food supplement by a factor of 40 could have implications in the API space.
01-Mar-2017 - Lab staff at an API plant run by Chongqing Pharma Research Institute Co., Ltd. deleted out of spec test results according to the US Food and Drug Administration (FDA).