The US FDA says Ko Da Pharmaceutical facility in Taoyuan City, Taiwan will not be able to supply the US unless the firm corrects all GMP deviations identified during an inspection last May.
The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US last year.
Aesica Pharmaceuticals has adopted a flexible serialization system capable of helping customer meet track and trace requirements in China, Korea and other key markets.
Envirotainer has opened a ‘service station’ in Delhi, India to help local API and generic drug manufacturers comply with international shipping regulations.
The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.
Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.
3D printing can make drug production simpler and cheaper according to a UK expert who says using it for commercial production is about “numbering up” not scaling up.
The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.
The US FDA has published draft revisions to a thirteen-year old CMC guidance it says will increase the flexibility of post-approval changes for drugmakers.
Janssen is already working on continuous manufacturing methods for other drugs says Rutgers University which helped develop the new Prezista production process approved by the US FDA.
Drug companies should share more details of their APIs and the green credentials of the companies that supply says an award winning environmental researcher.
The Swiss importer that supplied fake Harvoni to Israel has named the Indian manufacturer from which it bought the drug and is cooperating with an investigation say regulators.
Swissmedic has warned hepatitis C sufferers not to buy Harvoni from unknown sources after fake versions of the Gilead drug imported by a Swiss trading company were found in Israel.
Controlled substances and peptides are on AMRI’s wish list as it profits from a growth strategy which has seen six acquisitions over the past two years.
Fresenius Kabi has moved into the prefilled syringe space by acquiring Becton, Dickinson and Company’s injectables business and US manufacturing plant.
Restarting production at the former Ben Venue facility in Ohio will be a “significant task” says Xellia Pharmaceuticals which plans to invest after buying the site from Hikma.
Tweaks to EU orphan drug rules (OD) may be needed to accommodate Ebola treatment development and block industry attempts to delay generic entry says the European Commission.
Horizon Pharma has hit back at allegations it was secretly working with a “captive pharmacy” to preferentially dispense its own drugs, claiming its accuser is trying to reduce competition with its own distribution service.
Piramal chief executive Vivek Sharma won last week’s CPhI award for the pharma industry’s CEO of the year. Outsourcing-Pharma.com spoke to Sharma about his plans for the CDMO the day after the jury’s unanimous decision.
The US FDA has revoked approval for Sun Pharmaceutical Industries’ extended-release epilepsy drug Elepsia XR over concerns the firm's manufacturing plant in Halol, India does not meet quality standards.
Royal DSM will make up to 1100 staff redundant by the end of 2017 to cut costs following the formation of its Sinochem JV and pharma products deal with Patheon.
