Gelatin firm Rousselot BV has joined IPEC Europe describing the move as an opportunity to contribute to the development of regulatory standards for pharmaceutical excipients.
Gilead Sciences Inc. faces renewed allegations it bought an API used in three of its HIV drugs from an unapproved Chinese supplier after a US Court of Appeals ruling.
Newlink Genetics Corporation has expended its indoximod IP portfolio weeks after data suggested the cancer drug may make Provenge and Keytruda more effective.
Bayer has pulled-out of a development and licensing deal for a pseudoephedrine containing product based on Acura Pharmaceuticals’ methamphetamine resistant technology, Impede.
Japanese regulators are investigating allegations API firm Yamamoto Chemical Industry gave inspectors false information and improperly bulked-up batches of acetaminophen and zonisamide.
The European Medicines Agency has approved a new tablet formulation of Esbriet (pirfenidone), which Roche says reduces pill-load and increases dosing flexibility for patients with a rare lung disease.
The Carlyle Group and GTCR LLC are poised to complete the takeover of Albany Molecular Research (AMRI) after the early termination of the mandatory waiting period that covers such deals in the US.
BASF has said it will build an ibuprofen plant in Ludwigshafen, Germany and increase production capacity for the API at a facility in Bishop, Texas in the US.
The European Commission has confirmed that UK drug ingredient manufacturers will have to supply European customers with written confirmation their products are made in compliance with EU standards after Brexit.
Cure Pharmaceutical has entered into a strategic collaboration to test and develop potential cancer therapeutics utilising a blend of the cannabis plant-derived terpenes.
The High Court of Delhi, India, has granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement of DSM Sinochem Pharmaceuticals’ enzyme-based antibiotic production IP.
IFPMA launches Alliance to track drug firms' progress in the fight against ‘superbugs'.
Drug manufacturers, retail pharmacies and regulators have a role to play in curbing antimicrobial resistance say campaigners urging industry to ensure their API suppliers are not part of the problem.
Cefic has agreed to make sure its members only sell the intermediate gamma butyrolactone (GBL) to legitimate users to stop it being abused or used in “date rape” drug GHB.
With almost 40% of attendees coming from outside the US, the political climate has had no effect on the latest CPhI franchise which starts today in Philadelphia.
Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.
The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.
An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.
Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.
Deutsche Post DHL Group’s contract logistics business, DHL Supply Chain, has announced its intention to acquire Brazilian transport service provider Polar Transportes.
Smithfield Foods Inc. has tasked a new bioscience unit with turning byproducts from its pork business into supplies for regenerative meds and drug firms.
Industrial action at a Pfizer Ireland Ltd plant in Ringaskiddy, County Cork has ended after the firm agreed to let 35 new staff to join the company pension scheme.
A Combino Pharm dosage form plant in Malta has passed a US FDA inspection according to parent Medichem, which says it is now poised to expand its US business.
India has told state regulators to inspect API sites making oxytocin in an effort to prevent the hormone being used to speed up childbirth without medical justification.
The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.
