Hospira has received a US FDA Warning Letter at an Australian injectables facility months after workers asked the firm not turn the site into “the new Rocky Mount.”
The acquisition of Shasun Pharmaceuticals will add API production and contracting services to Strides Arcolab, and according to Shasun’s CEO no jobs will be lost.
Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.
West Pharmaceutical Services has confirmed it is evaluating potential expansions but says rumours that it plans to pay €100m ($130m) for a facility in Ireland are premature.
Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
Pfizer and Sun Pharmaceutical Industries have boosted their sterile injectables businesses through the respective acquisitions of InnoPharma and the CMO Pharmalucence.
Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.
Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing...
Until final regulations are finished, the US FDA has released draft guidance describing the agency’s expectations for outsourcing facilities and the cGMP requirements for them.
The US FDA has set emphasising the benefits of QbD, traceability and risk based manufacturing facility inspections as strategic priorities for the next four years in document published for consultation this week.
A regulatory expert has warned of the “unintended consequences” of that would require the US Food and Drug Administration (FDA) to begin reviewing drug candidates within 90 days of their approval in the EU.
The use of ethanol as a diluent in injectables is under the spotlight following a new US FDA warning that its presence in the cancer medicine docetaxel poses an intoxication risk.
Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant
As manufacturers will have to identify illegitimate product for trading partners and the US FDA beginning next year, the agency is now offering pragmatic advice in the form of draft guidance for drugmakers regarding situations where suspect product might...
European regulatory authorities have reinstated the Good Manufacturing Practice (GMP) certificate at Ranbaxy Laboratories’ API manufacturing site in Toansa, India, which was suspended in January.
Johnson Matthey has completed restructuring its API unit and plans to pursue more generics industry business, after non-branded drug launches drove fine chemicals growth in fiscal 2014.
The Form 483 from the US FDA cited Chicago-based Morton Grove Pharmaceuticals, which was acquired by Wockhardt in October 2007, for 12 different observations.
For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.
Sun Pharma says the closure of a Michigan plant employing 179 staff is necessary in order to consolidate its US manufacturing network, and not related to its Ranbaxy acquisition.
Albemarle has agreed to sell its ibuprofen business to US chemical intermediates firm SI Group in a deal that will also see it divest the anaesthetic agent, propofol.
AMRI will acquire Cedarburg Pharmaceuticals for $38.2m (€27.7) in cash, plus $2.8m of assumed liabilities, to expand its API and drug development offerings.
Sun Pharma’s antibiotic facility import alert is the latest blow to the Indian drug industry but is unlikely to impact revenues or cause US shortages, the firm says.
Publication of a US FDA enforcement report detailing a recall by Ranbaxy in January saw the beleaguered Indian drugmakers’ share price fall 3% last week.
Criminal access to APIs must be cut off in a way that does not infringe generics companies’ right to buy chemicals, a top US prosecutor told In-Pharmatechnologist.com.
AMRI says it intends to expand its API business to target both generics and more complex molecules after reporting record full year revenue from contract services.
