Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the overseas facilities.
The UK government’s health committee is calling for all clinical trial information to be in the public domain but industry push back is expected, experts say.
Indian pharmaceutical exporters now need to apply barcodes on their secondary packages as part of an effort to increase safety and traceability, but some have avoided the requirements, experts say.
In-PharmaTechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from AstraZeneca and Roche.
UK CMP Aesica has continued its strategy of partnering with academics with a new collaboration designed to make operations at its Cramlington plant more efficient.
EU pharmaceutical and active substance manufacturers should determine the threshold for cross-contamination when multiple drugs are produced in shared facilities.
The drug industry is seeking more clarity on the descriptions of variations made to marketed drugs under the European Commission’s regulation governing the ways marketing authorizations can be re-classified.
BASF says revised offer for omega-3 API maker Pronova Biopharma is fair value given recent Greek Government decision to stop reimbursing two key drugs.
Cambridge Major Labs’ (CML) new private-equity investor plans to expand the CMO’s chemistry and API business and assess cross selling synergies with other firms in its portfolio.
The US Food and Drug Administration (FDA) can require opioid generics to have abuse-deterrent properties if the same requirements are applicable to their brand name counterparts, FDA Commissioner Margaret Hamburg said in a letter to Rep. Fred Upton (R-Mich.)...
The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.
United Parcel Service (UPS) has abandoned its bid to buy Holland-based logistics firm TNT Express after the European Commission said it would block the deal.
IDIFarma has been cleared to make commercial batches of high potency tablets and hopes the new capability will attract developers of niche drugs and large CMOs.
Exela Pharma Sciences will invest $8.5million in its research and manufacturing plant in North Carolina. The venture, to be spread over the next three years, will provide 38 new jobs almost doubling its present workforce.
Private equity group Warburg Pincus has acquired sterile injectables specialist JHP Pharmaceuticals for $195m and says it has a “sizable amount” to invest in the CMO.
Saltigo says climbing raw materials, energy and shipping costs prompted it to increase the price of key chemical intermediates, 1,2,4-triazole and chloroformate.
The Indian Pharmacopoeia Commission (IPC) says a first of its kind guidance manual will help drugmakers comply with quality requirements and testing procedures.
Mitsubishi Chemical Holdings (MCHC) has announced plans to buy the ‘dominant’ pharma-grade HPMC capsule maker Qualicaps as the global gelatin shortage continues.
An advocacy group says actor Jack Klugman's support was key for US law that encouraged pharmaceutical firms to make drugs for rare diseases over the past 30 years.
