IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.
Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.
In response to stakeholder feedback, the US FDA has issued a final guidance detailing changes to the regulatory classification of co-crystals, from intermediate to API.
Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
The International Pharmaceutical Excipient Council (IPEC) has updated its Quality Agreement guidelines to reflect changing regulatory expectations and global nature of supply chains.
The acquisition of FMC Corporation's health and nutrition business gives DowDuPont “one of the broadest pharma offerings to serve the growing excipients industry,” the firm says.
Drug firms need excipients suited to continuous manufacturing according to Dow, which says a better understanding of how products perform when used in round-the-clock production is required.
Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.
Cambrex Corporation has announced plans to start making high potency APIs at its plant in Milan, Italy citing impending patent losses for small molecule drugs as an opportunity.
BASF has announced plans for a specialty amines plant at its site on the Nanjing Chemical Industry Park in China, citing increasing demand from customers in Asia.
A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.
Price controls and procurement programmes would favour drugs containing locally-made APIs under a Government proposal designed to reduce India's reliance on imported ingredients and intermediates.
Tesaro Inc has hired STA Pharmaceutical Co. Ltd to supply intermediates for its recently approved, $117k-a-year, ovarian cancer drug Zejula (niraparib).
GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and respiratory drug capacity.
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.
Failure to establish system suitability testing for heparin and heparin-related drugs has landed Shandong Analysis and Test Center a US FDA warning letter.
Cure Pharmaceutical has entered into a strategic collaboration to test and develop potential cancer therapeutics utilising a blend of the cannabis plant-derived terpenes.
Pop Test Abuse Deterrent Technologies has received a patent for an opioid drug delivery and abuse deterrent ‘smart pill’ it says can prevent death, theft, diversion and counterfeiting.